Clinical trial NCT03840915
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-small Cell Lung Cancer Bintrafusp alfa (proposed INN) M7824 Stage IV INTR@PID LUNG 024
Sponsor: EMD Serono Research & Development Institute, Inc.
Start date: 2019-04-02; Completion date: 2022-07-29
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of the study was to evaluate the safety and tolerability of M7824 in combination with chemotherapy.

Detailed description:

Arms: arm 1: Participants received 2400 miligrams (mg) Bintrafusp alfa along with Cisplatin or Carboplatin, and Pemetrexed every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death. arm 2: Participants received 2400 mg Bintrafusp alfa along with Carboplatin, and Paclitaxel or Nab-paclitaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death. arm 3: Participants received 2400 mg Bintrafusp alfa along with Cisplatin or Carboplatin, and Gemcitabine every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death. arm 4: Participants received 2400 mg Bintrafusp alfa along with Docetaxel every 3 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
Interventions: intervention 1: Cisplatin intervention 2: Carboplatin intervention 3: Pemetrexed intervention 4: Nab-paclitaxel intervention 5: Gemcitabine intervention 6: Docetaxel intervention 7: M7824 intervention 8: Carboplatin intervention 9: Carboplatin intervention 10: Bintrafusp alfa intervention 11: Paclitaxel
Intervention descriptions: intervention 1: Cisplatin was administered intravenously at a dose of 75 milligrams per meter square (mg/m\^2) over 60 minutes every 21 days for 4 cycles (each cycle is 21 days). intervention 2: Carboplatin was administered at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days). intervention 3: Pemetrexed was administered intravenously at a dose of 500 mg/ m\^2 over 10 minutes every 21 days. intervention 4: Nab-paclitaxel was administered intravenously at as dose of 100 mg/m\^2 over 30 minutes in a 21 days cycle on Day 1, 8, and 15 in each cycle for 4 cycles (each cycle is 21 days). intervention 5: Gemcitabine was administered intravenously at a dose of 1250 mg/m\^2 over 30 minutes in a 21 days cycle on Day 1, and 8, in each cycle for 4 cycles (each cycle is 21 days). intervention 6: Docetaxel was administered intravenously at a dose of 75 mg/m\^2 over 60 minutes every 21 days for 4 cycles (each cycle is 21 days). intervention 7: M7824 was administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 and pemetrexed. intervention 8: Carboplatin was administered at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days). intervention 9: Carboplatin was administered at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days). intervention 10: M7824 was administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 alone. intervention 11: Paclitaxel was administered intravenously at a dose of 200 mg/m2 over 3 hours every 3 weeks for 4 cycles (each cycle is 21 days).

Protocol documents:
Prot_000.pdf: 
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1  
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Dis p ositi o n of Partici pa nts a n d Disc o nti n uati o ns  ...............................2 8  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
5 /8 5  
 
 
1 0. 2  
Pr ot oc ol De viati o ns / E xcl usi o n fr o m A nal ysis P o p ulati o ns  ..............3 1  
1 0. 2. 1  
I m p orta nt Pr ot oc ol De viati o ns ............................................................3 1  
1 1  
De m o gra p hics a n d Ot her Baseli ne C haracteristics  .............................3 2  
1 1. 1  
De m o gra p hics  .....................................................................................3 2  
1 1. 2  
Me dical Hist or y  ..................................................................................3 3  
1 1. 3  
Ot her B aseli ne C haracteristics  ............................................................3 3  
1 1. 3. 1  
Disease Hist or y  ...................................................................................3 3  
1 1. 3. 2  
E C O G Perf or ma nce Stat us at Baseli ne  ...............................................3 5  
1 1. 3. 3  
E C G at Baseli ne  ..................................................................................3 5  
1 1. 3. 4  
Vital Si g ns at Baseli ne  ........................................................................3 5  
1 1. 3. 5  
S ki n Stat us Hist or y  .............................................................................3 6  
1 1. 3. 6  
Nic oti ne C o ns u m pti o n  ........................................................................3 6  
1 2  
Pre vi o us or C o nc o mita nt Me dicati o ns/ Pr oce d ures  .............................3 6  
1 2. 1  
Pre vi o us A ntica ncer Me dicati o ns  .......................................................3 6  
1 2. 2  
Pre vi o us a n d C o nc o mita nt Me dicati o ns  .............................................3 7  
1 2. 3  
C o nc o mita nt Pr oce d ures  .....................................................................3 8  
1 2. 4  
S u bse q ue nt A ntica ncer Treat me nt  ......................................................3 8  
1 2. 5  
Pre me dicati o ns  ....................................................................................3 9  
1 3  
St u d y I nter ve nti o n C o m plia nce a n d E x p os ure  ...................................3 9  
1 4  
Efficac y A nal yses  ...............................................................................4 3  
1 4. 1  
Pri mar y E n d p oi nt A nal ysis  .................................................................4 4  
1 4. 2  
Sec o n dar y E n d p oi nt A nal ysis  .............................................................4 4  
1 4. 2. 1  
C o nfir me d O bjecti ve Res p o nse Acc or di n g t o R E CI S T 1. 1 as 
Assesse d b y I n vesti gat or  .....................................................................4 4  
1 4. 2. 2  
S u b gr o u p A nal ysis f or C o nfir me d O bjecti ve Res p o nse  .....................4 6  
1 4. 2. 3  
Pr o gressi o n -Free S ur vi val Acc or di n g t o R E CI S T 1. 1 as Assesse d 
b y I n vesti gat or  ....................................................................................4 6  
1 4. 2. 4  
O verall S ur vi val  ..................................................................................4 8  
1 4. 2. 5  
S u b gr o u p A nal ysis f or P F S a n d O S  ....................................................4 9  
1 4. 2. 6  
Se nsiti vit y A nal ysis f or P F S  ...............................................................4 9  
1 4. 2. 7  
D urati o n of Res p o nse  .........................................................................4 9  
1 4. 3  
F urt her E n d p oi nt A nal yses  .................................................................5 0  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 /8 5  
 
 
1 4. 3. 1  
F oll o w -u p Ti me f or P F S  .....................................................................5 0  
1 4. 3. 2  
F oll o w -u p Ti me f or O S  ......................................................................5 0  
1 4. 3. 3  
Pr o gressi o n -Free S ur vi val 2  ...............................................................5 1  
1 4. 3. 4  
Ti me t o Res p o nse  ...............................................................................5 2  
1 4. 3. 5  
T u m or S hri n ka ge i n Tar get Lesi o ns  ...................................................5 2  
1 4. 3. 6  
Brai n Lesi o ns  ......................................................................................5 2  
1 4. 3. 7  
Dela ye d Res p o nse after I nitial Pr o gressi o n  ........................................5 3  
1 4. 3. 8  
T u m or Res p o nse as A dj u dicate d b y I R C  ............................................5 3  
1 5  
Safet y A nal yses  ..................................................................................5 3  
1 5. 1  
A d verse E ve nts  ...................................................................................5 3  
1 5. 1. 1  
All A d v erse E ve nts .............................................................................5 7  
1 5. 1. 2  
A d verse E ve nts Lea di n g t o St u d y I nter ve nti o n Disc o nti n uati o n  .......6 2  
1 5. 2  
Deat hs, Ot her Seri o us A d verse E ve nts, a n d Ot her Si g nifica nt 
A d verse E ve nts  ...................................................................................6 7  
1 5. 2. 1  
Deat hs  .................................................................................................6 7  
1 5. 2. 2  
Seri o us A d verse E ve nts  ......................................................................6 8  
1 5. 2. 3  
D ose -Li miti n g T o xicit y  ......................................................................6 8  
1 5. 2. 4  
Blee di n g E ve nts  ..................................................................................6 9  
1 5. 2. 5  
A d verse E ve nts of S pecial I nterest  .....................................................6 9  
1 5. 2. 5. 1  
I nf usi o n-Relate d Reacti o ns I ncl u di n g I m me diate H y perse nsiti vit y  ...6 9  
1 5. 2. 5. 2  
I m m u ne-Relate d A Es  ..........................................................................6 9  
1 5. 2. 5. 3  
S ki n T E A Es  ........................................................................................7 0  
1 5. 2. 5. 4  
A ne mia  ................................................................................................7 1  
1 5. 3  
Cli nical La b o rat or y E val uati o n ...........................................................7 1  
1 5. 4  
Vital Si g ns  ..........................................................................................7 4  
1 5. 5  
Ot her Safet y or T olera bilit y E val uati o ns  ............................................7 5  
1 6  
A nal yses of Ot her E n d p oi nts  ..............................................................7 5  
1 6 . 1 
P har mac o ki netics  ................................................................................7 5  
1 6. 1. 1  
Missi n g/ n o n -q ua ntifia ble P K Data Ha n dli n g  .....................................7 6  
1 6. 1. 2  
Descri pti ve P K A nal ysis  .....................................................................7 6  
1 6. 1. 3  
P har mac o ki netic N o n -C o m part me ntal A nal ysis  ................................7 8  
 
 
Gl o bal Versi o n I D: C CI
C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
7 /8 5  
 
 
1 6. 3  
I m m u n o ge nicit y ..................................................................................8 0  
1 7  
Refere nces  ...........................................................................................8 4  
1 8  
A p pe n dices  .........................................................................................8 5  
1 8. 1  
A p pe n di x 1: List of I m p orta nt Pr ot oc ol De viati o ns  ...........................8 5  
1 8. 2  
A p pe n di x 2: I de ntificati o n of Pre vi o us or C o nc o mita nt 
Me dicati o ns  .........................................................................................8 5  
1 8. 3  
A p pe n di x 3: Defi niti o n of N CI -C T C A E Gra di n g  ..............................8 5  
 
Gl o bal Versi o n I D: C CI
C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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I N F O R M A T I O N 
8 /8 5  
 
 
2  
L ist of A b bre vi ati o ns a n d Defi niti o n of Ter ms  
A D A   
A nti d r u g anti b o d y  
A E  
A d verse E ve nt  
A E SI   
A d verse E ve nt of S pecial I nterest  
A L T   
Ala ni ne a mi n otra nsferase  
A L K   
A na plastic l y m p h o ma ki nase  
A L P  
Al kali ne p h os p hatase  
A S T  
As partate tra nsa mi nase  
A T C   
A nat o mical T hera pe utic C he mical  
A U C 0 -t  
Area u n der t he c o nce ntrati o n-ti me c ur ve fr o m ti me zer o ( = d osi n g ti me) 
t o t he last sa m pli n g ti me at w hic h t he c o nce ntrati o n is at or a b o ve t he l o wer 
li mit of q ua ntificati o n 
A U C 0 -∞  
Area u n der t he c o nce ntrati o n -ti me c ur ve fr o m ti me zer o ( d osi n g ti me) 
e xtra p olate d t o i nfi n it y 
B L Q   
Bel o w t he l o wer li mit of q ua ntificati o n  
B MI  
B o d y Mass I n de x  
B S A   
B o d y S urface Area  
B M  
Bi o mar ker  (a nal ysis p o p ulati o n) 
C e oi 
T he c o nce ntrati o n o bser ve d i m me diatel y at t he e n d of i nf usi o n  
CI  
C o nfi de nce I nter val  
Cr Cl   
Creati n i ne Cleara nce 
C ma x    
Ma xi m u m o bser ve d c o nce ntrati o n  
C O VI D -1 9   
2 0 1 9 N o vel C or o na vir us Disease  
C R  
C o m plete Res p o nse  
C S R   
Cli nical St u d y Re p ort  
C T  
C he m ot hera p y  
 
 
C T/ M RI   
C o m p ute d T o m o gra p h y/ Ma g netic Res o na nce I ma gi n g  
C T C A E   
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts  
C tr o u g h  
T he 
c o nce ntrati o n 
o bser ve d 
i m me diatel y 
bef ore 
ne xt 
d osi n g 
(c orres p o n di n g t o pre-d ose or tr o u g h c o nce ntrati o n f or m ulti ple d osi n g)  
C V %   
C oefficie nt of variati o n  
Gl o bal Versi o n I D: C CI
C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
9 /8 5  
 
 
D B P   
Diast olic Bl o o d Press ure  
D C R   
Disease c o ntr ol rate 
D L T   
D ose -Li miti n g T o xicit y  
D o D R   
D urati o n of Dela ye d Res p o nse  
D o R  
D urati o n of Res p o nse  
E C O G P S   
Easter n C o o perati ve O nc ol o g y Gr o u p Perf or ma nce Stat us  
E C G   
Electr ocar di o gra m  
e C R F   
Electr o nic Case Re p ort F or m  
E G F R   
E pi der mal Gr o wt h Fact or Rece pt or  
E O T   
E n d of Treat me nt  
F A S  
F ull A nal ysis Set (a nal ysis p o p ulati o n)  
G C P   
G o o d Cli nical Practices  
Ge o C V %   
Ge o metric C oefficie nt of V ariati o n 
Ge o Mea n   
Ge o metric M ea n 
G F R   
Gl o mer ular Filtrati o n Rate  
I A P 
I nte grate d A nal ysis Pla n 
I C H 
I nter nati o nal C o u ncil f or Har m o nizati o n 
I H C 
I m m u n o hist oc he mistr y 
I M M  
I m m u n o ge nicit y (a nal ysis p o p ulati o n) 
ir A E  
I m m u ne-relate d A d verse E ve nt  
I R C 
I n de pe n de nt Re vie w C o m mittee 
I R R 
I nf usi o n-relate d reacti o n 
 
 
K A  
Kerat oaca nt h o ma  
λ Z  
Ter mi nal first or der (eli mi nati o n) rate c o nsta nt  
L L N   
L o wer Li mits of N or mal  
L L O Q   
L o wer L i mit of Q ua ntificati o n  
Ma x  
Ma xi m u m  
Mea n   
Arit h metic mea n  
Me d D R A   
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
Mi n  
Mi ni m u m  
Gl o bal Versi o n I D: C CI
C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
1 0 /8 5  
 
 
n  
N u m ber of n o n -missi n g o bser vati o ns  
N CI  
Nati o nal Ca ncer I nstit ute  
n d  
N ot deter mi ne d  
N S C L C   
N o n -small cell l u n g ca ncer  
N E  
N ot E val ua ble  
O R R   
O bjecti ve res p o nse rate 
O S  
O verall S ur vi val  
P D  
Pr o gressi o n of disease  
 
   
P F S  
Pr o gressi o n -Free S ur vi val  
 
 
P K  
P har mac o ki netic  
P K A S   
P har mac o ki netic A nal ysis S et (a nal ysis p o p ulati o n) 
P R  
Partial Res p o nse  
P T  
Preferre d Ter m  
Q Tc F   
C orrecte d Q T i nter val b y Fri dericia  
R DI  
Relati ve D ose I nte nsit y  
R E CI S T 1. 1   
Res p o nse E val uati o n Criteria i n S oli d T u m ors Versi o n 1. 1   
S A E  
Seri o us A d verse E ve nt  
S A F  
Safet y A nal ysis Set (a nal ysis p o p ulati o n) 
S B P  
S yst olic Bl o o d Press ure  
S C R  
Scree ni n g (a nal ysis p o p ulati o n)  
S D  
Sta ble Disease  
S D T M   
St u d y Data Ta b ulati o n M o del  
S M C   
Safet y M o nit ori n g C o m mittee  
S O C   
S yste m Or ga n Class  
S C C  
S q ua m o us C ell C arci n o ma 
S tD  
Sta n dar d D e viati o n 
t1/ 2 
A p pare nt ter mi nal  (eli mi nati o n) half -life 
T E A E   
Treat me nt -E mer ge nt A d verse E ve nt  
T G F β   
Tra nsf or mi n g G r o wt h F act or β 
Gl o bal Versi o n I D: C CI
C CI
C CI




 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
1 2 /8 5  
 
 
U ni q u e  
I d e ntifi er 
f or 
V er si o n  
D at e of  
I A P V er si o n  
A ut h or  
C h a n g e s fr o m t h e Pr e vi o u s V er si o n  
3. S e cti o n 1 0. 1: u p d at e d t h e c at e g ori z ati o n of p arti ci p a nt s 
p ot e nti all y i m p a ct e d b y C O VI D -1 9 w h o st art e d t h e 
tr e at m e nt b ef or e t h e p a n d e mi c (fr o m r e c ei v e d at l e a st o n e 
d o s e d uri n g t h e p a n d e mi c t o o n -st u d y d uri n g t h e 
p a n d e mi c).  
4. S e cti o n 1 4. 2. 4 : u p d at e d r e as o n s f or o v er all s ur vi v al 
c e n s ori n g.  
5 . S e cti o n 1 5. 1. 1: 
- a d d e d a n o v er vi e w of tr e at m e nt -e m er g e nt a d v er s e 
e v e nt s b y A D A st at u s (tr e at m e nt e m er g e nt A L L  v er s u s 
n o n tr e at m e nt A L L ). 
- u p d at e d t h e i d e ntifi c ati o n of C O VI D -1 9 r el at e d a d v er s e 
e v e nt s ( fr o m: b a s e d o n a pr e d efi n e d li st of t er m s pr o vi d e d 
b y M e d D R A; t o: pr ef err e d t er m c o nt ai n s C O VI D-1 9 or 
S A R S -C O V -2).  
6. S e cti o n 1 6. 3:  
- a d d e d a n e w c at e g ori z ati o n f or A D A st at u s (tr e at m e nt 
e m er g e nt A L L  v er s u s n o n tr e at m e nt e m er g e nt A L L ). 
- a d d e d a s u m m ar y of t h e  ti m e t o A D A o n s et a n d d ur ati o n 
of A D A i m m u n o g e ni cit y r e s p o n s e.   
- a d d e d a li sti n g of A D A r e s ult s f or tr e at m e nt e m er g e nt 
A L L  p arti ci p a nt s.  
7. R e m o v e d s e n siti vit y a n al y s e s f or o bj e cti v e r e s p o n s e, 
o v er all s ur vi v al, a n d pr o gr e s si o n -fr e e s ur vi v al (r e pli c at e d 
a n al y si s b a s e d o n t h e c h e m ot h er a p y r e gi m e n t h at w a s 
gi v e n m o stl y ). 
8. S e cti o n 1 0. 1: a d d e d t h e n u m b er a n d p er c e nt a g e of 
p arti ci p a nt s w h o s wit c h e d t h e c h e m ot h er a p y r e gi m e n.  
9. R e n a m e d p ot e nti al T G F β -m e di at e d s ki n a d v er s e  
e v e nt s  a s T G F -β  i n hi biti o n m e di at e d s k i n a d v er s e  e v e nt s . 
4  
P ur p ose of t he I nte gr ate d A n al ysis Pl a n  
T he p ur p ose of t his I nte grate d A nal ysis Pla n (I A P) is t o d oc u me nt tec h nical a n d detaile d 
s pecificati o ns f or t he i nteri m, mai n , a n d f oll o w-u p a nal yses  of data c ollecte d f or pr ot oc ol 
M S 2 0 0 6 4 7 _ 0 0 2 4.  
Res ults of t he a nal yses descri be d i n t his I A P will be i ncl u de d i n t he Cli nical St u d y Re p ort ( C S R). 
A d diti o nall y, t he pla n ne d i nteri m , mai n , a n d f oll o w -u p a nal yses i de ntifie d i n t his I A P will be 
i ncl u de d i n re g ulat or y s u b missi o ns or f ut ure ma n uscri pts. A n y p ost-h oc, or u n pla n ne d a nal yses 
perf or me d t o pr o vi de res ults f or i ncl usi o n i n t he C S R b ut n ot i de ntifie d i n t his pr os pecti ve I A P 
will be clearl y i de ntifie d i n t he C S R.  
T he  I A P is base d u p o n Secti o n  9 ( Statistical C o nsi derati o ns) of t he st u d y pr ot oc ol a n d is pre pare d 
i n c o m plia nce wit h I nter nati o nal C o u ncil f or Har m o nizati o n (I C H) G ui deli ne E 9.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
1 3 /8 5  
 
 
5  
O bjecti ves a n d E n d p oi nts   
T he o bjecti ves a n d e n d p oi nts are defi ne d i n  Ta ble 1 .  
T a ble 1    
St u d y O bjecti ves a n d E n d p oi nts   
 
O bj e cti v e  
E n d p oi nt  
I A P s e cti o n 
Pri m ar y  
O bj e cti v e  
T o e v al u at e t h e s af et y a n d 
t ol er a bilit y of bi ntr af u s p alf a i n 
c o m bi n ati o n wit h c h e m ot h er a p y  
•  
O c c urr e n c e of d o s e -li miti n g to xi citi e s 
(D L T s ) d uri n g t h e 3 -w e e k D L T o b s er v ati o n 
p eri o d  
•  
O c c urr e n c e of tr e at m e nt-e m er g e nt 
a d v er s e e v e nt s ( T E A E s ) a n d tr e at m e nt -
r el at e d a d v er s e e v e nt s ( A E s ) 
S af et y 
A n al y s e s 
1 5. 2. 3  
S e c o n d ar y 
O bj e cti v e  
T o e v al u at e o bj e cti v e re s p o n s e 
rat e ( O R R) f or bi ntr af u s p alf a i n 
c o m bi n ati o n wit h c h e m ot h er a p y  
C o nfir m e d o bj e cti v e r e s p o n s e a c c or di n g t o 
R e s p o n s e E v al u ati o n Crit eri a i n S oli d T u m or s 
V er si o n 1. 1 ( R E CI S T 1. 1) a s s e s s e d b y 
In v e sti g at or  
Effi c a c y 
A n al y s e s  
1 4. 2 . 1 
T o e v al u at e p r o gr e s si o n-fr e e 
s ur vi v al ( P F S ) f or bi ntr af u s p alf a 
i n c o m bi n ati o n wit h c h e m ot h er a p y 
P F S a c c or di n g t o R E CI S T 1. 1 a s s e s s e d b y 
In v e sti g at or  
Effi c a c y 
A n al y s e s  
1 4. 2. 3  
T o e v al u at e o v er all s ur vi v al ( O S) 
f or bi ntr af u s p alf a i n c o m bi n ati o n 
wit h c h e m ot h er a p y  
O S  
Effi c a c y 
A n al y s e s  
1 4. 2. 4  
T o e v al u at e d ur ati o n of re s p o n s e 
(D o R ) f or bi ntr af u s p alf a i n 
c o m bi n ati o n wit h c h e m ot h er a p y  
D o R a s s e s s e d fr o m c o m pl et e re s p o n s e ( C R) 
or p arti al re s p o n s e ( P R) u ntil p r o gr e s si o n of 
d i s e a s e ( P D) or d e at h 
Effi c a c y 
A n al y s e s  
1 4. 2. 7  
T o c h ar a ct eri z e p h ar m a c o ki n eti c 
( P K) pr ofil e of bi ntr af u s p alf a  
•  
P K pr ofil e of bi ntr af u s p alf a i n t er m s of Ce oi  
a n d C tr o u g h f or all p arti ci p a nt s 
•  
P K pr ofil e of bi ntr af u s p alf a i n t er m s of 
A U C 0 -t, A U C0 -∞, Cm a x , tm a x , λ Z , a n d t 1/ 2  ( o nl y 
f or p arti ci p a nt s i n t h e s af et y p art of t h e 
st u d y)  
A n al y s e s of 
Ot h er 
E n d p oi nt s  
1 6. 1  
T o e v al u at e t h e i m m u n o g e ni cit y 
of bi ntr af u s p alf a  
I m m u n o g e ni cit y of bi ntr af u s p alf a , a s 
m e a s ur e d b y a nti d r u g a nti b o d y ( A D A) a s s a y, 
fr o m S cr e e ni n g t hr o u g h t h e l a st S af et y 
F oll o w -u p Vi sit  
A n al y s e s of 
Ot h er 
E n d p oi nt s  
1 6. 3  
Gl o bal Versi o n I D: C CI
C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
1 4 /8 5  
 
 
A D A = a nti dr u g a nti b o d y, A E = a d v er s e e v e nt, A U C 0 -t = T h e ar e a u n d er t h e c o n c e ntr ati o n -ti m e c ur v e ( A U C) fr o m 
ti m e z er o ( = d o si n g ti m e) t o t h e l a st s a m pli n g ti m e (tl a st) at w hi c h t h e c o n c e ntr ati o n i s at or a b o v e t h e l o w er li mit of  
q u a ntifi c ati o n, A U C 0 -∞ = T h e A U C fr o m ti m e z er o ( d o si n g ti m e) e xtr a p ol at e d t o i nfi nit y, C e oi  = c o n c e ntr ati o n 
o b s er v e d i m m e di at el y at t h e e n d of i nf u si o n; Cm a x  = M a xi m u m o b s er v e d c o n c e ntr ati o n, C R  = c o m pl et e r e s p o n s e, 
C tr o u g h = c o n c e ntr ati o n i m m e di at el y b ef or e n e xt d o si n g, 
, D L T = d o s e-li miti n g 
t o xi cit y, D o R = d ur ati o n of re s p o n s e I H C = i m m u n o hi st o c h e mi str y, I R C = I n d e p e n d e nt R e vi e w  
C o m mitt e e, ir P F S = i m m u n e -r el at e d pr ogr e s si o n -fr e e s ur vi v al, ir R E CI S T = i m m u n e-r el at e d R e s p o n s e E v al u ati o n 
Crit eri a i n S oli d T u m or s, O R R = o bj e cti v e r e s p o n s e r at e, O S = o v er all s ur vi v al, P D = pr o gr e s si o n of di s e a s e, P D L 1  
= pr o gr a m m e d d e at h li g a n d 1, P F S = pr o gr e s si o n -fr e e s ur vi v al, 
 
, P K = p h ar m a c o ki n eti c s, P R = p arti al r e s p o n s e, 
R E CI S T 1. 1 = re s p o n s e r e s p o n s e ev al u ati o n c rit eri a i n s oli d tu m or s v er si o n 1. 1, T E A E = tr e at m e nt-e m er g e nt 
a d v er s e  
e v e nt, T M B = t u m or m ut ati o n al b ur d e n, t m a x  = T h e ti m e t o r e a c h t h e m a xi m u m o b s er v e d c o n c e ntr ati o n c oll e ct e d 
d uri n g a d o si n g i nt er v al,  t1/ 2  = a p p ar e nt t er mi n al  ( eli mi n ati o n) h alf -lif e, λZ  = t er mi n al fir st or d er ( eli mi n ati o n) r at e 
c o n st a nt.  
6  
O ver vie w of Pl a n ne d A n al yses   
T his I A P f oc use s o n i nteri m , mai n , a n d f oll o w -u p  a nal yses. A se parate statistical a nal ysis pla n will 
be pr o vi de d f or t he Safet y M o nit ori n g C o m mittee ( S M C) . Ta ble 2  bel o w dis pla ys a n o ver vie w of 
t he pla n ne d  a nal yses. 
F urt her a nal yses ma y be perf or me d, e. g. , f or p u blicati o n p ur p oses. I nteri m a nal yses at ti me p oi nts 
t hat are n ot s pecifie d i n t he pr ot oc ol ma y be perf or me d f or i nter nal pla n ni n g p ur p oses.  
T a ble 2    
O ver vie w of Pl a n ne d  A n al yses   
A n al y si s  
D at a c ut off d at e  
D L T a n al y si s   
S af et y will b e cl e ar e d b a s e d o n D L T s o b s er v e d i n e a c h of t h e f o ur c o h ort s d uri n g t h e s af et y 
r u n-i n p art of t h e st u d y w h e n t h e l a st p arti ci p a nt c o m pl et e s D L T o b s er v ati o n p eri o d i n t h e 
c orr e s p o n di n g c o h ort.  
E arl y i nt eri m 
a n al y si s  
T h e d at a c ut off d at e f or t h e e arl y i nt eri m a n al y si s i s s et t o t h e 7t h of O ct o b er, 2 0 2 0.  
Gl o bal Versi o n I D: C CI
C CI
C CI
C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
1 5 /8 5  
 
 
I nt eri m a n al y si s 
If C o h ort A i s e x p a n d e d t o N = 4 0 p arti ci p a nt s, a n i nt eri m a n al y si s will b e c o n d u ct e d 6 m o nt h s 
aft er t h e tr e at m e nt st art of t h e l a st p arti ci p a nt i n t h e e x p a n d e d pil ot c o h ort ( C o h ort A). 
M ai n a n al y si s  
T h e m ai n a n al y si s of  s af et y a n d  effi c a c y e n d p oi nt s will b e c o n d u ct e d 1 8 m o nt h s aft er t h e 
tr e at m e nt st art of t h e l a st p arti ci p a nt of C o h ort A . 
F oll o w -u p 
a n a y si s  
T h e  f oll o w-u p a n al y si s will b e c o n d u ct e d at t h e e n d of t h e st u d y. T h e e n d of st u d y i s d efi n e d 
a s 3 y e ar s aft er tr e at m e nt st art of t h e l a st p arti ci p a nt or u ntil all t h e p arti ci p a nt s i n t h e st u d y 
e x p eri e n c e d pr o gr e s si v e di s e a s e t o t h e s u b s e q u e nt tr e at m e nt, w hi c h e v er o c c ur s fir st.  T h e 
st u d y c o ul d al s o r e a c h a n e n d o n c e a c c e s s t o st u d y i nt er v e nti o n f or p arti ci p a nt s  still b e n efiti n g 
i s pr o vi si o n e d vi a a r oll o v er st u d y, e x p a n d e d a c c e s s, m ar k et e d pr o d u ct or a n ot h er 
m e c h a ni s m of a c c e s s a s a p pr o pri at e.  
T he ti mi n g of c o n d uct of t he i nteri m , mai n , a n d f oll o w-u p  a nal yses will be tri g gere d b y t he data 
c ut off dates me nti o ne d  i n Ta ble 2 . 
6. 1  
S afet y M o nit ori n g C o m mittee   
A S M C  will be res p o nsi ble f or peri o dic safet y e val uati o ns of t he st u d y. Details ca n be  f o u n d i n t he 
S M C C harter.  
T he S M C will als o clear safet y base d o n D L Ts o bser ve d i n  eac h of  t he f o ur c o h orts d uri n g t he 
safet y r u n-i n part of t he st u d y w he n t he 8t h e val ua ble partici pa nt of eac h c o h ort c o m pletes D L T 
o bser vati o n peri o d .  
A s pecific statisti cal a nal ysis pla n will be pre pare d f or t he S M C.  
6. 2  
E arl y I nteri m A n al ysis   
A n earl y i nteri m a nal ysis will be perf or me d base d o n data c ut at 0 7 -Oct -2 0 2 0. T his i nteri m a nal ysis 
is i nte n de d f or i nter nal pla n ni n g p ur p oses a n d will i ncl u de t he f oll o wi n g efficac y e n d p oi nts: 
•  C o nfir me d o bjecti ve res p o nse  
•  Pr o gressi o n -free s ur vi val  
•  O verall s ur vi val  
•  D urati o n of res p o nse  
Partici pa nt dis p ositi o n, de m o gra p hics, me dical hist or y, pre vi o us a ntica ncer me dicati o ns, disease 
hist or y, treat me nt c o m plia nce a n d e x p os ure, a n d safet y data ( A Es a n d cli nical la b orat or y 
e val uati o ns) will als o be descri be d.  
T he f ull list of ta bles, listi n g s a n d fi g ures t o be pr o vi de d is i de ntifie d i n t he ta ble of c o nte nt of t he 
o ut p ut s hells.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
1 6 /8 5  
 
 
6. 3  
I nteri m A n al ysis  
O nce t he safet y pr ofile of t he pil ot c o h ort ( C o h ort A) has bee n cleare d b y t he S M C, a n a d diti o nal 
3 2 partici pa nts will be e nr olle d i n t he e x pa nsi o n part of C o h ort A res ulti n g i n a t otal sa m ple size 
of N = 4 0 partici pa nts . A n i nteri m a nal ysis will be c o n d uc te d 6 m o nt hs after t he treat me nt start of 
t he last partici pa nt i n t he e x pa n de d pil ot c o h ort t o assess a d diti o nal safet y data a n d preli mi nar y 
efficac y a n d will descri be:  
•  C o nfir me d o bjecti ve res p o nse  (e xcl u di n g t he a nal ysis perf or me d  o n t he s u bset of 
partici pa nts wit h 6 m o nt hs of f oll o w -u p)  
•  Pr o gressi o n -free sur vi val  (e xcl u di n g t he a nal ysis perf or me d o n t he s u bset of partici pa nts 
wit h 6 m o nt hs of f oll o w -u p)  
•  D urati o n of res p o nse  
Partici pa nt dis p ositi o n, de m o gra p hics, me dical hist or y, pre vi o us a ntica ncer  me dica ti o ns a n d ot her 
baseli ne c haracteristics ( disease hist or y, Easter n C o o perati ve O nc ol o g y Gr o u p Perf or ma nce Stat us 
[ E C O G P S]), treat me nt c o m plia nce a n d e x p os ure, a n d safet y a nal yses ( A Es a n d cli nical la b orat or y 
e val uati o ns) will als o be descri be d at t he ti me  of t he i nteri m a nal ysis.   
I m m u n o ge nicit y a n d P K a nal ysis  will be perf or me d w he n all partici pa nts i n eac h c o h ort of t he 
safet y r u n-i n ha ve fi nis he d C ycle 2. Res ults will be e val uate d b y Cli nical P K/ P D gr o u p ( C P K) of 
Tra nslati o nal Me dici ne, Merc k Healt hcare K Ga A, Dar msta dt, Ger ma n y . 
6. 4  
M ai n A n al ysis   
T he mai n a nal ysis of safet y a n d efficac y e n d p oi nts c o nsi deri n g partici pa nts of C o h ort A, will be 
c o n d ucte d 1 8 m o nt hs after t he treat me nt start of t he last partici pa nt of t he c o h ort. All pla n ne d 
a nal yses i de ntifie d i n t his I A P  (e xcl u di n g t he a nal ysis of efficac y e n d p oi nts perf or me d o n t he 
s u bset of partici pa nts wit h 6 m o nt hs of f oll o w-u p)  will be perf or me d o nl y after t his peri o d wi t h all 
st u d y data i n-h o use, all data q ueries res ol ve d, a n d t he data base l oc ke d.  A D ata R e vie w M eeti n g 
will be hel d pri or t o data base l oc k. I n a d diti o n, n o data base ca n be l oc ke d u ntil t his I A P has bee n 
a p pr o ve d. 
6. 5  
F oll o w -u p  A n al ysis   
A f oll o w -u p a nal ysis will be c o n d ucte d at t he e n d of t he st u d y. T he e n d of st u d y is defi ne d as 3 
years after treat me nt start of t he last partici pa nt or u ntil all t he partici pa nts i n t he st u d y e x perie nce d  
pr o gressi ve disease t o t he s u bse q ue nt treat me nt, w hic he ver occ urs first. T he f oll o wi n g a nal ysis will 
be perf or me d:  
•  Dis p ositi o n of p artici pa nts 
•  O verall s ur vi val  ( Secti o ns 1 4 . 2.4 , 1 4. 2. 5 , 1 4. 3. 2 ) 
•  Pr o gressi o n -free s ur vi val ( Secti o n 1 4. 3. 3 ) 
Gl o bal Versi o n I D: C CI




 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
1 8 /8 5  
 
 
I nstea d, a d diti o nal o ut p uts (s u m mar y ta bles a n d listi n gs) will be ge nerate d t o assess p ote ntial 
i m pacts of C O VI D-1 9 o n  t his st u d y i ncl u di n g:  
•  S u m mar y of partici pa nts i n pre/ d uri n g/ p ost C O VI D -1 9 st u d y peri o d  
•  S u m mar y of C O VI D -1 9 relate d pr ot oc ol de viati o ns  
•  S u m mar y of 
C O VI D -1 9 i m pact ( misse d st u d y i nter ve nti o n a d mi nistrati o ns, t u m or 
assess me nts or misse d visits d ue t o C O VI D -1 9 ) 
•  Listi n g of A Es relate d t o C O VI D -1 9  
8  
A n al ysis P o p ul ati o ns a n d S u b gr o u ps   
8. 1  
Defi niti o n of A n al ysis P o p ul ati o ns   
Scree ni n g A n al ysis Set ( S C R)  
T he Scree ni n g A nal ysis S et i ncl u des all partici pa nts, w h o pr o vi de d i nf or me d c o nse nt, re gar dless 
of t he partici pa nt’s st u d y i nter ve nti o n stat us i n t he st u d y.  
D ose -li miti n g to xicities A n al ysis Set ( D L T)  
T he d ose -li miti n g to xicities  A nal ysis  S et i ncl u des all  partici pa nts  of t he D L T e val uati o n (t he first 
8 partici pa nts of eac h c o h ort) w h o were a d mi nistere d wit h at least 9 0 % of t he bi ntraf us p alfa 
i nf usi o n d uri n g t he D L T o bser vati o n peri o d of 3 wee ks a n d di d n ot disc o nti n ue treat me nt f or ot her 
reas o ns t ha n D L T.  
F ull A n al ysi s Set ( F A S) 
T he F ull A nal ysis S et i ncl u des all partici pa nts, w h o were a d mi nistere d a n y d ose of a n y st u d y 
i nter ve nti o n. A nal yses will c o nsi der partici pa nts as treate d. I n case t he c he m ot hera p y re gi me n was 
s witc he d, t he partici pa nt will be a nal yze d wit hi n t he first c he m ot hera p y re gi me n a n d c o h ort.  
If m ore t ha n 1 0 % s witc hers occ ur i n a c o h ort (i.e., t w o or m ore s witc hers i n C o h ort B t o D a n d 
fi ve or  m ore i n C o h ort A) , se nsiti vit y a nal yses f or efficac y will be perf or me d c o nsi deri n g t he 
c he m ot hera p y t hat was gi v e n m ostl y a n d t he res pecti ve c o h ort.  
S afet y A n al ysis Set ( S A F)  
T he S afet y A nal ysis S et i ncl u des all partici pa nts, w h o were a d mi nistere d a n y d ose of a n y st u d y 
i nter ve nti o n. A nal yses will c o nsi der partici pa nts as treate d. I n case t he c he m ot hera p y re gi me n was 
s witc he d, t he partici pa nt will be a nal yze d wit hi n t he first c he m ot hera p y re gi me n a nd c o h ort.  
P h ar m ac o ki netic A n al ysis Set ( P K A S ) 
Gl o bal Versi o n I D: C CI




 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
2 0 /8 5  
 
 
o  a ge ≥ 6 5 years  
•  Se x  
o  Male  
o  Fe male  
•  Ge o gra p hic Re gi o n  
o  N ort h A merica  
o  Lati n A merica  
o  Wester n E ur o pe  
o  Easter n E ur o pe  
o  A ustralia  
o  Asia  
•  Race  
o  W hite  
o  Blac k or Africa n A merica n  
o  Asia n  
o  A merica n I n dia n or Alas ka Nati ve  
o  Nati ve Ha waiia n or Ot her Pacific Isla n der  
o  N ot c ollecte d at t his site  
o  M ore t ha n o ne race  
o  Ot her  
•  Hist ol o g y  
o  S q ua m o us  (i.e., s q ua m o us cell carci n o ma or a de n os q ua m o us carci n o ma) 
o  N o n -s q ua m o us (i.e., all ot her hist ol o gies)  
•  S m o ki n g stat us:  
o  Ne ver s m o ker  
o  E ver s m o ker  
•  Brai n metastasis at Baseli ne ( base d o n “tar get lesi o ns” a n d “ n o n-tar get” lesi o ns e C R F pa ges) 
o  Yes  
o  N o  
•   Li ver metastasis at Baseli ne ( base d o n “tar get lesi o ns” a n d “ n o n-tar get” lesi o ns e C R F pa ges) 
o  Yes  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
2 1 /8 5  
 
 
o  N o  
•  C he m ot hera p y ( C o h ort s A a n d C se paratel y a n d c o h orts A a n d C c o m bi ne d, base d o n first 
c he m ot hera p y recei ve d  f or A E s u m maries; C o h ort A o nl y f or efficac y s ub gr o u p a nal ysis ) 
o  Cis plati n  
o  Car b o plati n  
•  A D A  stat us (see Secti o n 1 6. 3  f or defi niti o n) 
o  Ne ver p ositi ve  
o  E ver p ositi ve  
  
     A N D  
o  Treat me nt e mer ge nt A L L vers us  
o  N o n -treat me nt e mer ge nt A L L 
F or varia bles wit h m ore t ha n t w o cate g ories, i n case of l o w n u m ber of partici pa nts wit hi n a 
cate g or y ( < 1 0 partici pa nts), cate g ories will be p o ole d.  
O nl y s u b gr o u p varia bles wit h a mi ni m u m of 1 0 partici pa nts per s u b gr o u p will be c o nsi dere d f or 
efficac y para meters.  
9  
Ge ner al S pecific ati o ns f or D at a A n al yses   
U nless ot her wise i n dicate d , all ge neral (i.e., dis p ositi o n of partici pa nts a n d disc o nti n uati o ns, 
pr ot oc ol de viati o ns, de m o gra p hic s a n d ot her baseli ne c haracteristics, a n d pre vi o us or c o nc o mita nt 
me dicati o n), safet y a n d efficac y a nal yses will be perf or me d b y c o h ort ( C o h orts A, B, C a n d D) 
a n d c o m bi ni n g C o h ort A, B, a n d C ( 1 L C o h ort  A, B, C ). Listi n gs will o nl y be pr o vi de d b y c o h ort 
a n d n ot c o m bi ne d.  T he s pecificati o ns f or P K data a nal ysis are prese nte d i n  Secti o n 1 6. 1 , a n d, i n 
case of discre pa ncies, Secti o n 1 6. 1  s hall s u perse de t his secti o n f or t he p ur p ose of P K data ha n dli n g, 
a nal ysis, a n d prese ntati o n.  
P o oli n g of ce nters:  
Beca use of t he hi g h n u m ber of partici pati n g ce nters a n d t he a ntici pate d s mall n u m ber of 
partici pa nts recr uite d i n eac h ce nter data will be p o ole d acr oss ce nters, a n d t he fact or ce nter will 
n ot be c o nsi dere d i n statistical m o dels or f or s u b gr o u p a nal yses.  
U nsc he d ule d assess me nts : 
As per data base defi niti o n, t he u nsc he d ule d safet y assess me nts are al wa ys li n ke d t o a sc he d ule d 
ti me p oi nt (eac h u nsc he d ule d assess me nt is li n ke d t o t he pre vi ous sc he d ule d ti me p oi nt). Safet y 
data retrie ve d fr o m a n u nsc he d ule d ti me p oi nt ( vital si g ns a n d la b orat or y data) will be a nal yze d 
acc or di n g t o t he f oll o wi n g sce nari o:  
•  F or s hift ta bles, t he y will be ta ke n i nt o acc o u nt i n t he defi niti o n of t he w orst assess me nt 
d uri n g t he st u d y  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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•  F or descri pti o n at eac h ti me p ost -baseli ne p oi nt, t he first a vaila ble res ult (i n c hr o n ol o gical 
or der) will be ta ke n i nt o acc o u nt i n t he a nal ysis i n case of m ulti ple val ues.  
F or anti d r u g anti b o d y ( A D A) a nal ysis, u nsc he d ule d visits will a ls o be ta ke n i nt o acc o u nt i n t he 
a nal ysis. 
F or P K a nal ysis, u nsc he d ule d sa m ples will n ot be li n ke d t o a sc he d ule d ti me p oi nt a n d will be 
e xcl u de d fr o m s u m maries.  
F or descri pti o n at Baseli ne , t he last a vaila ble/n o n -missi n g  res ult bef ore first st u d y i nter ve nti o n will 
be ta ke n i nt o acc o u nt i n t he a nal ysis i n case of m ulti ple val ues  (see f urt her details bel o w). 
Si g nific a nce le vel:  
T here is n o f or mal si g nifica nce le vel f or t his trial a n d all a nal yses are c o nsi dere d descri pti ve.  
Prese nt ati o n of c o nti n u o us  a n d q u alit ati ve v ari a bles:  
C o nti n u o us varia bles  ot her t ha n P K  will be s u m marize d usi n g t he f oll o wi n g descri pti ve statistics, 
i.e.,  
•  n u m ber of partici pa nts ( N), n u m ber of partici pa nts wit h missi n g val ues  
•  mea n, sta n dar d de viati o n  ( St D) 
•  me dia n, 2 5t h Perce nt ile - 7 5t h Perce ntile ( Q 1 -Q 3),  
•  mi ni m u m  ( Mi n) a n d ma xi m u m  ( Ma x). 
If t here are n o missi n g val ues t his s h o ul d be i n dicate d b y a 0. 
P har mac o ki netic varia bles (c o nce ntrati o ns a n d para meters) will be s u m marize d as descri be d i n 
Secti o n 1 6. 1. 2 . 
Q ualitati ve varia bles will be s u m marize d b y c o u nts a n d perce nta ges.  
U nless ot her wise state d t he calc ula ti o n of pr o p orti o ns will be base d o n t he n u m ber of partici pa nts 
of t he a nal ysis set of i nterest. T heref ore, c o u nts of missi n g o bser vati o ns will be i ncl u de d i n t he 
de n o mi nat or a n d prese nte d as a se parate cate g or y.  
I n case t he a nal ysis refers o nl y t o certai n visits, perce nta ges will be base d o n t he n u m ber of 
partici pa nts still prese nt i n t he st u d y at t hat visit, u nless ot her wise s pecifie d. 
St u d y i nter ve nti o n:  
I n th is st u d y, bi ntraf us p alfa a n d c he m ot hera p y are c o nsi dere d st u d y  i nter ve nti o ns. T he date of 
first st u d y i nter ve nti o n will be defi ne d as t he earliest date of a n y  treat me nts (bi ntraf us p alfa or 
c he m ot hera pies). T he date of last st u d y i nter ve nti o n will be defi ne d as t he latest date of a n y 
treat me nts (bi ntraf us p alfa or c he m ot hera pies).  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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Preferre d ter m f o r a n al ysis of W orl d He alt h Or g a niz ati o n’s Dr u g Dicti o n ar y ( W H O -D D) 
c o de d d at a:  
F or data c o de d acc or di n g t o W H O -D D (e. g., c o nc o mita nt me dicati o ns), s u m maries will be d o ne 
o n t he preferre d ter m ( P T) le vel w here t he preferre d ter m is c orres p o n di n g t o c o des e n di n g i n 
0 1 0 0 1. Wit h t his a p pr oac h, variati o ns of salt f or ms of acti ve i n gre die nts will be a nal yze d u n der 
t he sa me ter m, e. g., di p he n h y dra mi ne a n d di p he n h y dra mi ne h y dr oc hl ori de will be a nal yze d as t he 
sa me preferre d ter m di p he n h y drami ne.  
Re -scree ne d p artici p a nts: 
Re -scree ne d partici pa nts will be o nl y c o u nte d o nce i n t he scree ni n g a nal ysis set, c o nsi deri n g t he 
latest scree ni n g (scree ni n g wit h latest i nf or me d c o nse nt). If a partici pa nt is re-scree ne d se veral 
ti mes, t he n he will be c o unte d o nl y o nce i n t he dis p ositi o n ta ble i n t he n u m ber of re -scree ne d 
partici pa nts.  
S oft w are:  
All a nal yses will be perf or me d usi n g S A S 9. 4 or hi g her i n t he S A S Gri d e n vir o n me nt. T he 
c o m p uter pr o gra m P h oe ni x ® 
Wi n N o nli n ® versi o n 6. 4 or hi g her will be use d t o deri ve P K 
para meters a p pl yi n g n o n -c o m part me ntal a nal ysis ( N C A).  
9. 1  
D at a H a n dli n g after C ut -off D ate   
Data after t he c ut off will n ot u n der g o t he clea ni n g pr ocess, a n d will be c ut at S D T M le vel, i.e., 
bef ore t he pr ocess of A D A M creati o n. T he y will n ot be dis pla ye d i n a n y listi n gs or use d f or 
s u m mar y statistics, e. g., la b orat or y val ues of sa m ples ta ke n after data c ut off, A Es wit h o nset date 
after data c ut off, etc.  
St o p dates are n ot affe cte d b y t his r ule, e. g. , a st o p date of A Es, w hic h starts pri or t o t he c ut off, 
b ut st o p pe d after date of c ut off, will n ot be c ha n ge d.  
9. 2  
Defi niti o n of B aseli ne  a n d C h a n ge fr o m B aseli ne   
T he last a vaila ble / n o n-missi n g  assess me nt pri or t o t he first st u d y i nter ve nti o n is defi ne d as 
“ baseli ne” val ue or “ baseli ne” assess me nt f or safet y a n d efficac y a nal yses. If a n assess me nt is 
pla n ne d t o be perf or me d pri or t o t he first d ose of st u d y i nterve nti o n  i n t he pr ot oc ol a n d t he 
assess me nt is perf or me d o n t he sa me da y as t he first d ose of st u d y i nter ve nti o n, it will be ass u me d 
t hat it was perf or me d pri or t o st u d y i nter ve nti o n, if assess me nt ti me p oi nt is n ot c ollecte d or is 
missi n g. If assess me nt ti me p oi nts are c ollecte d, t he o bser ve d ti me p oi nt will be use d t o deter mi ne 
pre -d ose o n st u d y da y 1 f or baseli ne calc ulati o n. U nsc he d ule d assess me nts will be use d i n t he 
deter mi nati o n of baseli ne. H o we ver, if ti me is missi n g, a n u nsc he d ule d assess me nt o n st u d y da y 1 
will be c o nsi dere d t o ha ve bee n o btai ne d after st u d y i nter ve nti o n. 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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2 4 /8 5  
 
 
Partici pa nts w h o start i nter ve nti o n a n d disc o nti n ue fr o m t he st u d y o n t he sa me da y ma y ha ve 2 
differe nt sets of data c ollecte d o n st u d y da y 1 ( o ne d uri n g st u d y a n d o ne i n t he E n d of Treat me nt 
[ E O T]) visit. Data re p orte d at t he E O T visit are n ot eli gi ble f or baseli ne selecti o n.  
If a sc he d ule d pre-d ose meas ure me nt act uall y occ urre d p ost -d ose, t he n t he c orres p o n di n g 
meas ure me nt will be treate d a n d a nal yze d as if it was a n u nsc he d ule d p ost -d ose meas ure me nt.  
If a sc he d ule d p ost-d ose meas ure me nt act uall y occ urre d pre -d ose, t he n t he c orres p o n di n g 
meas ure me nt will be treate d a n d a nal yze d as if it was a n u nsc he d ule d pre -d ose meas ure me nt.  
A bs ol ute a n d perce nt c ha n ges fr o m ba seli ne are defi ne d as  
  
a bs ol ute c ha n ge = visit val ue –  baseli ne val ue  
  
perce nt c ha n ge = 1 0 0 * ( visit val ue –  baseli ne val ue) / baseli ne val ue  
9. 3  
St u d y D a y / St u d y Tre at me nt D a y   
Da y 1 is t he da y of start of st u d y treat me nt, t he da y bef ore is Da y -1 ( n o Da y 0 is defi ne d). St u d y 
da y / St u d y treat me nt da y is defi ne d relati ve t o Da y 1.  
9. 4  
Defi niti o n of D ur ati o n a n d ‘ti me si nce’ V ari a bles   
D urati o n will be calc ulate d b y ta ki n g t he differe nce of start a n d st o p date + 1 (e. g., s ur vi val ti me 
[ da ys] = date of deat h –  date of first st u d y i nt er ve nti o n + 1), if n ot ot her wise s pecifie d.  
T he ti me si nce a n e ve nt (e. g., ti me si nce first dia g n osis) will be calc ulate d b y s u btracti n g t he date 
of e ve nt fr o m t he refere nce date.  
9. 5  
C o n versi o n F act ors   
T he f oll o wi n g c o n versi o n fact ors will be use d t o c o n vert da ys i nt o m o nt hs or years:  
•  1 m o nt h = 3 0. 4 3 7 5 da ys  
•  1 year = 3 6 5. 2 5 da ys.  
9. 6  
D ate of l ast C o nt act   
T he f o ll o wi n g c o m plete dates will be use d t o deter mi ne t he last date k n o w n t o be ali ve. O nl y t he 
o nes a m o n g t he m t hat are bef ore or at data c ut off s hall be use d i n t he deri vati o n. Dates past t he 
data c ut off will be i g n ore d b y t he deri vati o n:  
•  All partici pa nt asse ss me nt dates ( bl o o d dra ws [la b orat or y, P K, vital si g ns, perf or ma nce stat us, 
E C G, t u m or assess me nts])  
•  Start a n d e n d dates of a ntica ncer t hera pies a d mi nistere d after st u d y i nter ve nti o n 
disc o nti n uati o n.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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•  A E start a n d e n d dates  
•  Last k n o w n ali ve date c ollecte d o n t he “ S u bject Stat us / S ur vi val F oll o w -u p” e C R F pa ge (d o 
n ot use t he f oll o w u p date ) 
•  St u d y i nter ve nti o ns start a n d e n d dates  
•  Date of disc o nti n uati o n fr o m t he “ St u d y Ter mi nati o n” e C R F pa ge ( d o n ot use if reas o n f or 
disc o nti n uati o n is l ost t o f oll o w -u p or deat h ) 
•  Data c ollecte d after rei nitiate d treat me nt will be c o nsi dere d i n t he deri vati o n of t he last k n o w n 
t o be ali ve date. 
O nl y dates ass ociate d wit h act ual e xa mi nati o ns of t he partici pa nt re p orte d i n t he e C R F will be 
use d i n t he deri vati o n. Dates ass oc iate d wit h a tec h nical o perati o n u nrelate d t o partici pa nt stat us 
s uc h as t he date a bl o o d sa m ple was pr ocesse d will n ot be use d.   
9. 7  
Ti me Wi n d o w   
N o ti me wi n d o w defi ne d.  
9. 8  
Defi niti o n of O n -tre at me nt P eri o d  
T he o n -treat me nt peri o d will i ncl u de t he i nitial treat me nt peri o d as well as t he rei nitiati o n of 
treat me nt peri o d, as a p plica ble. W het her a partici pa nt rei nitiates treat me nt (f oll o wi n g t he r ules as 
o utli ne d i n t he pr ot oc ol) or n ot, t he o n -treat me nt peri o d is defi ne d as t he ti me fr o m t he first st u d y 
i nter ve nti o n t o t he last st u d y i nter ve nti o n + 3 0 da ys , or  t he earliest date of s u bse q ue nt a ntica ncer 
t hera p y mi n us 1 da y, or deat h, o r t he data c ut-off date, w hic he ver occ urs first, u nless ot her wise 
state d.  
A n y s yste mic a ntica ncer t hera p y, a n y a ntica ncer s ur ger y a n d a n y a ntica ncer ra di ot hera p y will be 
c o nsi dere d as s u bse q ue nt a ntica ncer t hera p y ( b o ne ra di ot hera p y or brai n metastasis ra di ot hera p y 
is re gar de d as palliati ve treat me nt all o we d o n st u d y treat me nt a n d t heref ore n ot c o nsi dere d as 
s u bse q ue nt a ntica ncer t hera p y, w hereas ot her a ntica ncer t hera p y is c o nsi dere d as s u bse q ue nt 
t hera p y). 
F or i m m u ne -relate d A Es as liste d i n Secti o n 1 5. 2. 5. 2 , a n e x pa n de d o n-treat me nt peri o d will be 
use d as a defa ult f or a n y a nal ysis:  
Ti me fr o m t he first st u d y i nter ve nti o n t o t he last st u d y i nter ve nti o n date + 9 0 da ys, deat h O R t o 
t he earliest date of s u bse q ue nt a ntica ncer t hera p y mi n us 1 da y, w hic he ver occ urs first, u nless 
ot her wise state d.  
9. 9  
I m p ut ati o n of M issi n g D at a   
U nless ot her wise s pecifie d i n t his I A P, missi n g data will n ot be i m p ute d.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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Missi n g statistics, e. g. , w he n t he y ca n n ot be calc ulate d, s h o ul d be prese nte d as “ n d” f or “ n ot 
deter mi ne d. F or e xa m ple, if n = 1, t he meas ure of varia bilit y [e. g. , sta n dar d de viati o n ( St D)] ca n n ot 
be c o m p ute d a n d s h o ul d be prese nte d as “ n d”.  
H a n dli n g of i nc o m plete d ates : 
•  Missi n g d at a h a n dli n g r ules f or a ge c alc ul ati o n  
I nc o m plete dates ( date of i nf or me d c o nse nt, date of birt h) f or t he calc ulati o n of a ge will be 
i m p ute d as f oll o ws:  
o  I n case of missi n g da y f or at least o ne date, b ut m o nt h a n d year a vaila ble f or b ot h dates: 
t he da y of i nf or me d c o nse nt a n d t he da y of birt h will be set t o 1. 
o  I n case of missi n g m o nt h f or at least o ne date, b ut year a vaila ble f or b ot h dates, t he da y 
a n d t he m o nt h of i nf or me d c o nse nt a n d t he da y a n d m o nt h of birt h will be set t o 1. 
o  I n all ot her cases, t he i nc o m plete dates will n ot be i m p ute d.  
•  Missi n g d at a h a n dli n g r ules f or dise ase hist or y  
I nc o m plete dates f or disease hist or y ( date of i nitial dia g n osis date, date of d oc u me nte d, l ocall y 
a d va nce d, i n o pera ble or metastatic disease dia g n osis, date of res p o nse or pr o gressi o n i n pri or 
treat me nt) will be i m p ute d as f oll o ws:  
o  If t he da y is missi n g, it will be i m p ute d t o t he 1st da y of t he m o nt h.  
o  If b ot h da y a n d m o nt h are missi n g, t he m o nt h a n d da y will be i m p ute d as Ja n uar y 1st .  
o  If t he date is c o m pletel y missi n g, n o i m p utati o n will be perf or me d. 
•  
Missi n g d at a h a n dli n g r ules f or a d verse e ve nts  
I nc o m plete A E-relate d dates will be i m p ute d as f oll o ws:  
o  I n case t he o nset date is missi n g c o m pletel y or missi n g partiall y b ut t he o nset m o nt h 
a n d year, or t he o nset year are e q ual t o t he start of st u d y treat me nt t he n t he o nset date 
will be i m p ute d b y t he mi ni m u m of start of st u d y treat me nt a n d A E res ol uti o n date (if 
n ot missi n g).  
o  I n all ot her cases, t he missi n g o nset da y or missi n g o nset m o nt h will be i m p ute d b y 1. 
o  I nc o m plete st o p dates will be i m p ute d b y t he last da y of t he m o nt h (if da y is missi n g 
o nl y) , if n ot res ulti n g i n a date later t ha n t he date of partici pa nt’s deat h. I n t he latter 
case, t he date of deat h will be use d t o i m p ute t he i nc o m plete st o p date.  
o  I n all ot her cases, t he i nc o m plete st o p date will n ot be i m p ute d.  
•  
Missi n g d at a h a n dli n g r ules f or pre vi o us a n d c o nc o mit a nt me dic ati o ns (see A p pe n di x 
2 ) 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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I nc o m plete dates f or pre vi o us a n d c o nc o mita nt me dicati o ns will be i m p ute d as f oll o ws:  
F or start date of me dicati o n : 
o  If t he da y is missi n g, it will be i m p ute d t o t he 1st da y of t he m o nt h.  
o  If b ot h da y a n d m o nt h are missi n g, t he m o nt h a n d da y will be i m p ute d as Ja n uar y 1 st.  
o  If t he date is c o m pletel y missi n g, n o i m p utati o n will be perf or me d.  
F or e n d date me dicati o n:  
o  If t he da y is missi n g, it will be i m p ute d t o t he last da y of t he m o nt h.  
o  If b ot h da y a n d m o nt h are missi n g, t he m o nt h a n d da y will be i m p ute d as Dece m ber 
3 1 st. 
o  If t he date is c o m pletel y missi n g, n o i m p utati o n will be perf or me d. 
N ote: I n case t he i m p utati o n res ults i n a date later t ha n t he date of patie nt's deat h, t he n t he date 
of deat h will be use d t o i m p ute t he i nc o m plete st o p date.  
•  
Missi n g d at a h a n dli n g r ules f o r s u bse q ue nt a ntic a ncer t her a p y  
I nc o m plete dates f or start date of s u bse q ue nt a ntica ncer t hera p y ( dr u g t hera p y, ra di ot hera p y, 
s ur ger y) will be i m p ute d as f oll o ws a n d will be use d f or deter mi ni n g ce ns ori n g dates f or 
efficac y a nal yses a n d i n t he deri vati o n o f t he e n d of o n-treat me nt peri o d: 
o  If o nl y da y is missi n g, it will be i m p ute d as t he last da y of t he m o nt h u nless t he e n d 
date of s u bse q ue nt a ntica ncer t hera p y is bef ore t hat date. I n t hat case, t he i nc o m plete 
a ntica ncer t hera p y start date will be i m p ute d a s t he e n d date of t he a ntica ncer t hera p y. 
o  If b ot h da y a n d m o nt h are missi n g, n o i m p utati o n will be perf or me d.  
o  I nc o m plete s u bse q ue nt a ntica ncer t hera p y st o p dates will n ot be i m p ute d.  
•  
Missi n g d at a h a n dli n g r ules f or de at h d ate  
F or t he p ur p ose of s ur vi val a nal yses  ( P F S a n d O S), partiall y missi n g deat h dates will be i m p ute d 
as f oll o ws:  
o  If o nl y t he da y is missi n g, t he deat h date will be i m p ute d t o t he ma xi m u m of t he ( n o n -
i m p ute d) date after t he date of last k n o w n ali ve date a n d t he 1 5t h da y of t he m o nt h . 
o  Ot her wise it will n ot be i m p ute d . 
•   H a n dli n g r ules f or t u m or assess me nts  
o  If t here are m ulti ple sca n dates ass ociate d wit h a n e val uati o n, t he earliest of t he sca n 
dates ass ociate d wit h t he e val uati o n will be use d as t he date of assess me nt . 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
2 8 /8 5  
 
 
Partial dates, w hic h are n ot t o be i m p ute d acc or di n g t o t he I A P, will be prese nte d i n t he f or mat 
li ke “ _ _ _ _ _ Y Y Y Y”. If val ues are i m p ute d acc or di n g t o t he I A P, i m p ute d val ues will be prese nte d 
i n partici pa nt data listi n gs a n d i m p ute d i nf or mati o n will be fla g ge d.  
9. 1 0  
Sc ori n g of H R Q O L D at a   
N ot a p plica ble.  
9. 1 1  
D at a C ollecte d after R e-i niti ate d T re at me nt   
Data c ollecte d after re -i nitiati o n of treat me nt will be i ncl u de d i n s u m mar y ta bles f or all a nal yses. 
Data listi n gs will i ncl u de b ot h, d ata c ollecte d d uri n g t he first peri o d of treat me nt a n d d uri n g t he 
rei nitiati o n of treat me nt a n d data c ollecte d d uri n g t he rei nitiati o n of treat me nt will be fla g ge d. 
1 0  
St u d y P artici p a nts   
T he s u bsecti o ns i n t his secti o n i ncl u de s pecificati o ns f or re p orti n g partici pa nt  dis p ositi o n a n d 
treat me nt/trial disc o nti n uati o ns. A d diti o nall y,  pr oce d ures f or re p orti n g pr ot oc ol de viati o ns are 
pr o vi de d.  S u m maries will be prese nte d b y c o h ort, c o m bi ne d 1 L C o h ort A, B, C a n d all c o h orts 
c o m bi ne d. 
1 0. 1  
Dis p ositi o n of P artic ip a nts a n d Disc o nti n u ati o ns   
Descri pti ve statistics 
will be use d 
t o s u m marize partici pa nt  dis p ositi o n a n d reas o n f or 
disc o nti n uati o n, base d o n t he electr o nic case re p ort f or m (e C R F) data.  All partici pa nts wit hi n t he 
S C R A nal ysis Set will be c o nsi dere d.  
T he f oll o wi n g i nf or mati o n will be re p orte d  per c o h ort  ( C o h ort A, B, C, a n d D), 1 L C o h ort A, B, 
C  a n d o verall , i ncl u di n g rei nitiati o n p hase : 
•  T otal n u m ber of scree ne d partici pa nts  
•  T otal n u m ber of re -scree ne d partici pa nt s 
•  N u m ber of partici pa nt s w h o di d n ot c o nti n ue be y o n d scree ni n g o verall a n d gr o u pe d b y 
reas o n (partici pa nt  di d n ot meet all eli gi bilit y criteria, wit h dr e w c o nse nt , pr o gressi ve  disease, 
a d verse e ve nt, l ost t o f oll o w -u p, deat h, ot her)  
•  N u m ber of treate d partici pa nt s  
•  N u m ber 
a n d perce nta ge of partici pa nts 
w h o c o m plete d / disc o nti n ue d bi ntraf us p alfa 
treat me nt, gr o u pe d b y mai n reas o n deat h or pr o gressi o n of disease (as re p orte d o n “ M 7 8 2 4 
ter mi nati o n” pa ge of t he e C R F) 
•  N u m ber a n d perce nta ge of partici pa nts w h o c o m plete d / disc o nti n ue d c he m ot hera p y, gr o u pe d 
b y c he m ot hera p y a n d 
mai n reas o n d eat h or pr o gressi o n of disease (as re p orte d o n 
“ C he m ot hera p y ter mi nati o n” pa ge of t he e C R F)  
•  N u m ber  a n d perce nta ge  of partici pa nt s wit h bi ntraf us p alfa treat me nt o n-g oi n g  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
2 9 /8 5  
 
 
•  N u m ber a n d perce nta ge of partici pa nts wit h c he m ot hera p y s witc h , gr o u pe d b y c o m bi nati o n 
(e. g., cis plati n t o car b o plati n) 
•  N u m ber a n d perce nta ge of partici pa nts w h o rei nitiate d bi ntraf us p alfa treat me nt 
•  N u m ber a n d perce nta ge of partici pa nts w h o disc o nti n ue d treat me nt after bi ntraf us p alfa 
rei nitiati o n 
•  F or eac h c he m ot hera p y, n u m ber a n d perce nta ge of partici pa nts wit h treat me nt o n g oi n g  
•  N u m ber a n d perce nta ge of partici pa nt s w h o disc o nti n ue d t he st u d y, gr o u pe d b y mai n reas o n 
(as re p orte d o n “ St u d y ter mi nati o n” pa ge of t he e C R F). 
T he n u m ber of partici pa nt s i n eac h a nal ysis set defi ne d i n S ecti o n 8. 2  will als o be s u m marize d. 
T he perce nta ge of partici pa nt s wit h perce nta ge base d o n t he n u m ber of partici pa nt s i n t he F A S  
p o p ulati o n will be prese nte d  (e xce pt f or n u m bers re gar di n g scree ni n g ). T he n u m ber of  partici pa nts 
i n eac h a nal ysis set will als o be s u m marize d b y site.  
T he listi n g of partici pa nt  dis p ositi o n will i ncl u de all partici pa nt s (i.e., i ncl u di n g scree ni n g fail ures). 
T he listi n g will i ncl u de t he f oll o wi n g i nf or mati o n (if a p plica ble): c o h ort, parti ci pa nt i de ntifier, 
date of i nf or me d c o nse nt, i ncl u de d i n t he st u d y, reas o n f or e xcl usi o n, first/last st u d y i nter ve nti o n 
date, reas o n off -treat me nt, date a n d reas o n off-st u d y, p o p ulati o n fla gs. W he n t he reas o ns, s uc h as 
t he reas o n off-treat me nt is cate g orize d as “ Ot her, s pecif y” , “ Pr ot oc ol n o n-c o m plia nce, s pecif y” or 
“Wit h dr a wal b y s u bject, s pecif y”, t he ver bati m te xt as e ntere d i n t he e C R F will be prese nte d i n 
t he listi n g.  
If a n y re-scree ne d partici pa nt s will be o bser ve d, a listi n g of re-scree ne d partici pa nt s will be 
pr o vi de d a n d will i ncl u de t he f oll o wi n g i nf or mati o n: c o h ort , partici pa nt  i de ntifier, date of 
i nf or me d c o nse nt, date of first a d mi nistrati o n of st u d y i nter ve nti o n, partici pa nt  i de ntifier at scree n 
fail ure, date of i nf or me d c o nse nt at scree n fail ure, date of scree ni n g fail ure, reas o n of scree ni n g 
fail ure. 
I n a d diti o n, a listi n g of partici pa nts f or w hic h bi ntraf us p alfa has bee n rei nitiate d will be pr o vi de d 
wit h t he f oll o wi n g i nf or mati o n: c o h ort, partici pa nt i de ntifier, date of first st u d y i nter ve nti o n, date 
of last st u d y i nter ve nti o n, reas o n f or treat me nt ter mi nati o n, first a n d last rei nitiati o n bi ntraf us p alfa 
a d mi nistrati o n date, stat us at e n d of treat me nt rei nitiati o n, a n d pri mar y reas o n f or per ma ne nt 
bi ntraf us p alfa disc o nti n uati o n. W he n t he reas o n  is cate g orize d as “ Ot her, s pecif y”, “ Pr ot oc ol n o n-
c o m plia nce, s pecif y” or “ Wit h d ra wal b y s u bject, s pecif y”, t he ver bati m te xt as e ntere d i n t he e C R F 
will be prese nte d i n t he listi n g . 
T he i n direct i m pact of C O VI D -1 9 will be assesse d as f oll o ws:  
•  T he n u m ber a n d perce nta ge of partici pa nts i n pre/ d uri n g/ p ost C O VI D -1 9 st u d y peri o d will 
be pr o vi de d : 
o  N u m ber of partici pa nts  w h o starte d treat me nt pri or t o t he C O VI D -1 9 st u d y peri o d  
▪ O n -st u d y d ur i n g t he C O VI D-1 9 st u d y peri o d  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
3 0 /8 5  
 
 
▪ Disc o nti n ue d t he st u d y bef ore start of t he C O VI D -1 9 st u d y peri o d  
o  N u m ber of partici pa nts  w h o starte d treat me nt d uri n g t he C O VI D -1 9 st u d y peri o d  
o  N u m ber of partici pa nts  w h o starte d treat me nt p osteri or t o t he C O VI D -1 9 st u d y 
peri o d  
T he C O VI D -1 9 st u d y peri o d is defi ne d as f oll o ws:  
•  T he start of C O VI D -1 9 st u d y peri o d will be defi ne d b y c o u ntr y as t he mi ni m u m of t he date 
of t he first deat h fr o m C O VI D -1 9 occ urre d i n eac h c o u ntr y (acc or di n g t o t he p u blis he d data 
b y E ur o pea n Ce ntre f or Disease Pre ve nti o n a n d C o ntr ol o n 2 6 t h J u ne 2 0 2 0) a n d 1 1 Marc h 
2 0 2 0 ( W H O -start of w orl d-wi de pa n de mic).  
•  P ost -pa n de mic c o ul d be defi ne d as date ( 1) vacci nati o n is release d, ( 2) 
W H O declares 
C O VI D -1 9 pa n de mic o ver, ( 3) re gi o n -s pecific calls are ma de t o e n d s ocial dista nci n g 
meas ures wit h n o rele va nt rise i n cases t hereafter.  
A n o ver vie w of t he C O VI D -1 9 i m pact o n t he st u d y will als o be pr o vi de d. T his will i ncl u de t he 
n u m ber a n d perce nta ge of pa rtici pa nts w h o meet t he f oll o wi n g ite ms: 
•  P ote ntiall y affecte d b y C O VI D -1 9  ( Starte d d uri n g pa n de mic/ Starte d bef ore pa n de mic a n d 
o n -st u d y d uri n g pa n de mic)  
•  At least o ne C O VI D -1 9 i m pact  
o  At least o ne a d verse e ve nt relate d t o C O VI D -1 9 (see Secti o n 1 5. 1. 1 ) 
o  N u m ber of partici pa nts w h o die d f or a n y reas o n relate d t o C O VI D -1 9  
o  At least o ne C O VI D -1 9 -relate d pr ot oc ol de viati o n 
o  At least o ne misse d d ose of bi ntraf us p alfa  
o  At least o ne misse d d ose of a n y c he m ot hera p y a ge nt s 
o  At least o ne misse d visit  ( base d o n pr ot oc ol de viati o ns) 
o  Cate g orizati o n of t he t otal n u m ber of misse d visits per partici pa nt ( 1, 2, 3 or > 3)  
o  At least o ne misse d t u m or assess me nt  ( base d o n pr ot oc ol de viati o ns) 
o  Cate g orizati o n of t he t otal n u m ber of misse d t u m or assess me nts per partici pa nt ( 1, 
2, 3 or > 3)  
o  At least o ne tele -visit re placi n g o n -site visit ( base d o n pr ot oc ol de viati o ns) 
o  Cate g orizati o n of t he t otal n u m ber of tele -visits re placi n g o n -site visits per 
partici pa nt ( 1, 2, 3 or > 3)  
o  N u m ber of partici pa nts w h o per ma ne ntl y  disc o nti n ue d bi ntraf us p alfa f or a n y 
reas o n relate d t o C O VI D-1 9  
o  N u m ber of partici pa nts w h o  per ma ne ntl y  disc o nti n ue d at least o ne c he m ot hera p y 
a ge nt  f or a n y reas o n relate d t o C O VI D-1 9  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
3 1 /8 5  
 
 
o  N u m be r of partici pa nts w h o disc o nti n ue d t he st u d y f or a n y reas o n relate d t o 
C O VI D -1 9  
A listi n g of all partici pa nts  affecte d b y C O VI D -1 9  i ncl u di n g t he o utc o me t o eac h cate g or y of t he 
o ver vie w ta ble, t he P T a n d A E n u m ber of A Es attri b ute d t o C O VI D -1 9, a n d t he C O V I D-1 9 relate d 
pr ot oc ol de viati o ns will als o be pr o vi de d.  
1 0. 2  
Pr ot oc ol De vi ati o ns / E xcl usi o n fr o m A n al ysis P o p ul ati o ns   
1 0. 2. 1   
I m p ort a nt Pr ot oc ol De vi ati o ns   
I m p orta nt pr ot oc ol de viati o ns are pr ot oc ol de viati o ns t hat 
mi g ht si g nifica ntl y affect t he 
c o m plete ness, acc urac y, a n d/ or relia bilit y of t he st u d y data or t hat mi g ht si g nifica ntl y affect a 
partici pa nt's ri g hts, s afet y, or well -bei n g.  
I m p orta nt pr ot oc ol de viati o ns i ncl u de: 
•  Partici pa nts w h o are d ose d o n t he st u d y des pite n ot satisf yi n g t he i ncl usi o n criteria;  
•  Partici pa nts w h o de vel o p wit h dra wal criteria w hilst o n t he st u d y b ut are n ot wit h dra w n;  
•  Partici pa nts w h o re cei ve a n i nc orrect d ose;  
•  Partici pa nts w h o recei ve a n e xcl u de d c o nc o mita nt me dicati o n;  
•  De viati o n fr o m G o o d Cli nical Practices ( G C P).  
I m p orta nt pr ot oc ol de viati o ns will be i de ntifie d a n d c o nfir me d pri or t o or at t he Data Re vie w 
Meeti n g at t he latest a n d will  be classifie d i n t he f oll o wi n g cate g ories: i nf or me d c o nse nt, 
eli gi bilit y a n d e ntr y criteria, c o nc o mita nt me dicati o n, la b orat or y assess me nt, st u d y pr oce d ure, 
seri o us a d verse e ve nt, ra n d o mizati o n, visit sc he d ule, I P c o m plia nce, efficac y, a d mi nistrati ve, 
s o urce d oc u me nt, re g ulat or y or et hics a p pr o vals, ot her. 
All i m p orta nt pr ot oc ol de viati o ns will be d oc u me nte d i n St u d y Data Ta b ulati o n M o del ( S D T M) 
datasets w het her i de ntifie d t hr o u g h site m o nit ori n g, me dical re vie w or pr o gra m mi n g.  
I m p orta nt pr ot oc ol de viati o ns will be defi ne d i n a s pecific d oc u me nt (see A p pe n di x 1 ), de viati o ns 
t o be c hec ke d pr o gra m maticall y will be i de ntifie d i n t his list. 
F urt her c o nsi der ati o ns f or P K:  
E xa m ples of i m p orta nt pr ot oc ol de viati o ns or i m p orta nt e ve nts f or P K i n ter ms of t his st u d y ma y 
i ncl ude, b ut ma y n ot be li mite d t o, t he f oll o wi n g:  
•  D ose dela ye d o utsi de t he all o we d wi n d o w  
•  A ct ual d osi n g ti me n ot rec or de d  
•  D ose c ha n ge or misse d d ose  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
3 2 /8 5  
 
 
•  Pre -d ose sa m ple c ollecte d after t he act ual start of i nf usi o n  
•  E n d -of -i nf usi o n sa m ple c ollecte d bef ore t he act ual e n d of i nf usi o n  
•  Sa m ple pr ocessi n g err ors t hat ma y lea d t o i nacc urate bi oa nal ytical res ults  
F or t he a b o ve i m p orta nt pr ot oc ol de viati o ns or i m p orta nt e ve nts f or P K, t he rele va nt P K data will 
be e xcl u de d fr o m s u m maries base d o n t he P K a nal ysis set.  
I m porta nt pr ot oc ol de viati o ns will be deter mi ne d f or all partici pa nt s b y eit her me dical re vie w 
pr ocesses , site m o nit ori n g or pr o gra m mi n g base d o n t he i ncl usi o n/e xcl usi o n criteria or ot her 
criteria prese nte d i n t he pr ot oc ol a n d d oc u me nte d i n S D T M. S u m maries wi ll be pr o vi de d f or t he 
F A S b y c o h ort a n d c o m bi ne d 1 L C o h ort A, B, C.  
T he f oll o wi n g s u m mar y ta bles a n d listi n gs of i m p orta nt pr ot oc ol de viati o ns will be pr o vi de d:  
•  Fre q ue nc y ta ble per cate g or y of i m p orta nt pr ot oc ol de viati o ns  
•  Listi n g of i m p orta nt pr ot oc ol de viati o ns  w hic h will i ncl u de partici pa nt i de ntifier, cate g or y 
of t he de viati o n, a n d a descri pti o n of t he de viati o n .  
A d diti o nall y, t he C O VI D -1 9 relate d pr ot oc ol de viati o ns will be descri be d as f oll o ws:  
•  Fre q ue nc y ta ble per cate g or y of i m p orta nt C O VI D -1 9 relate d pr ot oc ol de viati o ns  
•  Fre q ue nc y ta ble per cate g or y of n o n -i m p orta nt C O VI D-1 9 relate d pr ot oc ol de viati o ns  
o  Listi n g of C O VI D -1 9 relate d pr ot oc ol de viati o ns  
1 1  
De m o gr a p hics a n d Ot her B aseli ne C h ar acteristics   
S u m maries will be prese nte d f or t he F A S  b y c o h ort , c o m bi ne d 1 L C o h ort  A, B, C  a n d all c o h orts 
c o m bi ne d . 
1 1. 1  
De m o gr a p hics   
De m o gra p hic c haracteris tics will be s u m marize d usi n g t he f oll o wi n g i nf or mati o n fr o m t he 
Scree ni n g/ Baseli ne Visit eC R F pa ges.  
•  Se x : male, fe male 
•  Et h nicit y: His pa nic or Lati n o, n ot His pa nic or Lati n o  
•  Race :  
o  F or partici pa nts re p orti n g o ne race o nl y: W hite, B lac k or Africa n A merica n,  A sia n, 
A merica n I n dia n or Alas ka Nati ve , Nati ve Ha waiia n or Ot her Pacific Isla n der, N ot 
c ollecte d at t his site , M ore t ha n o ne race, a n d Ot her  
o  F or partici pa nts re p orti n g se veral races, all c o m bi nati o ns will be re p orte d  
•  A ge ( years): s u m mar y statistics  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
3 3 /8 5  
 
 
•  A ge cate g ories: < 6 5 years, ≥ 6 5 years ( 6 5 -7 4 years, 7 5 -8 4 years, ≥ 8 5 years)  
•  Ge o gra p hic Re gi o n: N ort h A merica, Lati n A merica, 
Wester n E ur o pe, Easter n E ur o pe, 
A ustralia, Asia  
S pecific ati o ns f or c o m p ut ati o n:  
•  A ge [ years]: ( date of gi ve n i n f or me d c o nse nt - date of birt h + 1) / 3 6 5. 2 5  
•  I n vesti gat or site c o des will be use d f or t he deter mi nati o n of t he partici pa nt’s ge o gra p hic re gi o n. 
T he relate d listi n g will als o be pr o vi de d wit h t he f oll o wi n g i nf or mati o n : c o h ort, partici pa nt  
i de ntifier, se x, race (i ncl u di n g all re p orte d races i n case of “ m ulti ple” races, a n d details i n case of 
“ ot her” race) , et h nicit y, ge o gra p hic re gi o n, a ge, a ge cate g or y . 
1 1. 2  
Me dic al Hist or y   
Rele va nt past a n d o n g oi n g me dical c o n diti o ns at Baseli ne will be s u m marize d fr o m t he “ Me dical 
Hist or y Details” e C R F pa ge, usi n g t he latest a vaila ble versi o n of 
Me dical Dicti o nar y f or 
Re g ulat or y Acti vities ( Me d D R A), preferre d ter m as e ve nt cate g or y a n d Me d D R A s yste m or ga n 
class ( S O C) b o d y ter m as B o d y S yste m cate g or y.  
Me dical hist or y will be dis pla ye d i n ter ms of fre q ue nc y ta bles  al p ha beticall y  or dere d b y S O C a n d 
P T. Eac h partici pa nt  will be c o u nte d o nl y o nce wit hi n eac h P T or S O C.  
T he relate d listi n g will als o be pr o vi de d wit h t he f oll o wi n g i nf or mati o n: c o h ort, partici pa nt 
i de ntifier, a ge, se x, race, preferre d ter m, re p orte d me dical hist or y ter m, start date, e n d date, relate d 
t o st u d y c o n diti o n, o n g oi n g, gra de. T his listi n g will be s orte d b y c o h ort, participa nt i de ntifier, start 
date, e n d date, preferre d ter m.   
1 1. 3  
Ot her B aseli ne C h ar acteristics   
Ot her baseli ne c haracteristics i ncl u d e disease hist or y, E C O G Perf or ma nce Stat us,  E C G val ues  a n d 
res ults, vital si g ns  a n d s ki n stat us hist or y.  La b orat or y res ults at Baseli ne will be prese nte d t o get her 
wit h t he res ults of all ot her la b orat or y assess me nts.  
1 1. 3. 1   
Dise ase Hist or y   
I nf or mati o n o n disease c haracteristics c ollecte d o n t he “ Disease Hist or y” e C R F pa ge will be 
s u m marize d as f oll o ws: 
•  T u m or hist ol o g y: a de n ocarci n o ma, s q ua m o us cell carci n o ma ( S C C), lar ge cell carci n o ma, 
a de n os q ua m o us carci n o ma, sarc o mat oi d carci n o ma, ne ur oe n d ocri ne carci n o ma, diff use 
i di o patic carci n o ma, ot her 
•  Ti me si nce i nitial ca ncer dia g n osis ( m o nt hs)  
•  Ti me si nce d oc u me nte d, l ocall y a d va nce d, i n o pera ble or metastatic disease dia g n osis ( m o nt hs)  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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C O N F I D E N T I A L  
I N F O R M A T I O N 
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•  T N M classificati o n at i nitial dia g n osis a n d at st u d y e ntr y: eac h T, N, M cate g or y will be 
descri be d ( T X, T 0, N 1, etc.)  
•  M olec ular a b n or malities:  
o  E pi der mal Gr o wt h Fact or Rece pt or ( E G F R) ( m utate d, wil d t y pe)  
o  A na plastic l y m p h o ma ki nase ( A L K) p ositi ve  ( yes, n o, n ot a p plica ble) 
o  R O S 1 rearra n g e me nt ( yes, n o , n ot a p plica ble) 
o  B R A F V 6 0 0 E m utati o n ( yes, n o , n ot a p plica ble) 
Gl o bal Versi o n I D: C CI
C CI




 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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I N F O R M A T I O N 
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1 1. 3. 5   
S ki n St at us Hist or y   
S ki n stat us hist or y is c ollecte d o n t he “ S ki n Stat us Hist or y” e C R F pa ge  wit h t he f oll o wi n g data : 
•  Pers o nal hist or y of fre q ue nt s u n b ur n ( Yes, N o, U n k n o w n)  
•  Pers o nal hist or y of eas y s u n b ur n ( Yes, N o, U n k n o w n)  
•  Pers o nal hist or y of s ki n ca ncer ( Yes, N o, U n k n o w n)  
•  Pers o nal hist or y of si g nifica nt U V e x p os ure ( Yes, N o, U n k n o w n)  
•  Pers o nal hist or y of p h ot ose nsiti vit y d ue t o  s ki n dis or der ( Yes, N o, U n k n o w n) 
•  Pers o nal hist or y of p h ot ose nsiti vit y d ue t o me dicati o n ( Yes, N o, U n k n o w n)  
•  Fa mil y hist or y of s ki n ca ncer i n first de gree relati ve (i.e. , pare nts, si bli n gs a n d/ or c hil dre n) 
( Yes, N o, U n k n o w n) 
A listi n g of s ki n stat us hist or y  will be pr o vi de d.  
1 1. 3. 6   
Nic oti ne C o ns u m pti o n   
T he nic oti ne c o ns u m pti o n i nf or mati o n will be c ollecte d fr o m t he “ Nic oti ne c o ns u m pti o n” e -C R F 
pa ge a n d it will be descri be d as f oll o ws:  
•  Nic oti ne use: Ne ver user, E ver user (i ncl u di n g f urt her brea k d o w n: f or mer / c urre nt) as 
c ollecte d i n e -C R F  
•  S m o ki n g e x p os ure ( pac k -years): 0, < 2 0, 2 0 -< 4 0, ≥4 0 a n d s u m mar y statistics  
•  Years si nce q uitti n g: ne ver s m o ker, c urre nt s m o ker, < 5, 5 -< 1 0, ≥1 0 a n d s u m mar y statistics 
Years si nce q uitti n g is c o m p ute d f or f or mer s m o kers o nl y as ( year of first st u d y i nter ve nti o n - 
e n d year of s m o ki n g).  
T he relate d listi n g will als o be pr o vi de d wit h t he f oll o wi n g i nf or mati o n: c o h ort, partici pa nt 
i de ntifier, a ge, se x, race, nic ot i ne use stat us ( ne ver use d/f or mer/c urre nt), n u m ber of s m oc ki n g pac k 
year, start a n d e n d date of nic oti ne c o ns u m pti o n, d urati o n of c o ns u m pti o n i n years . T his listi n g 
will be s orte d b y c o h ort  a n d partici pa nt i de ntifier.  
1 2  
P re vi o us  or C o nc o mit a nt Me dic ati o ns/ Pr oce d ures   
S u m maries will be perf or me d o n t he F A S  b y c o h ort a n d c o m bi ne d 1 L C o h ort  A, B, C .  
1 2. 1  
Pre vi o us A ntic a ncer Me dic ati o ns   
Pre vi o us antica ncer  m e dicati o ns f or N o n -small cell l u n g ca ncer (N S C L C ) are c ollecte d u n der t he 
“ Pri or A ntica ncer  Dr u g T hera pies f or N S C L C Details”, “ Pri or A ntica ncer  Ra di ot hera p y f or 
N S C L C Details”, a n d t he “ Pri or A ntica ncer  S ur geries f or N S C L C Details” e C R F pa ges.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
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T he n u m ber of partici pa nt s i n eac h of t he f oll o wi n g a ntica ncer  treat me nt cate g ories will be 
ta b ulate d: 
•  Partici pa nts wit h at least o ne pre vi o us a ntica ncer  treat me nt or pr oce d ure (i.e., dr u g t hera p y, 
ra di ot hera p y or s ur ger y) 
•  Partici pa nts wit h at least o ne pre vi o us a ntica ncer  dr u g t hera p y  
•  Partici pa nts wit h at least o ne pre vi o us a ntica ncer  ra di ot hera p y 
•  Partici pa nts wit h at least o ne pre vi o us a ntica ncer  s ur ger y. 
Pre vi o us a ntica ncer  dr u g t hera p y will be s u m marize d as f oll o ws:  
•  N u m ber of a n y pre vi o us a ntica ncer t hera p y re gi me ns:  0 / 1 / 2 / 3 / ≥ 4  
•  N u m ber of pre vi o us li nes of t hera p y f or metastatic/l ocall y  a d va nce d disease: 0 / 1 / 2  
•  I nte nt of t hera p y: Ne oa dj u va nt/ A dj u va nt/ Metastatic or l ocall y a d va nce d/ C he m ora diati o n  
•  Best res p o nse t o last treat me nt re gi me n: c o m plete res p o nse ( C R)/ partial res p o nse ( P R)/sta ble 
disease ( S D)/ pr o gressi o n of disease ( P D)/ n o n -c o m plete res p o nse or n o n -pr o gressi o n of disease 
( N o n C R/ N o n P D) / n ot e val ua ble ( N E)/ u n k n o w n.  
Pre vi o us a ntica ncer dr u g t hera p y, pre vi o us ra di ot hera p y, a n d pre vi o us a ntica ncer s ur ger y will be 
prese nte d i n se parate listi n gs as f oll o ws:  
•  T he pre vi o us a ntica nc er dr u g listi n g will c o ntai n c o h ort, partici pa nt  i de ntifier, a ge, se x, race, 
preferre d ter m, me dicati o n na me, start date, e n d date, r o ute, i nte nt of t hera p y a n d li ne n u m ber 
i n case of metastatic/l ocall y a d va nce d, best res p o nse a n d d oc u me nte d pr o gressi o n disease date. 
T his listi n g will be s orte d b y c o h ort, partici pa nt  i de ntifier, a ntica ncer  dr u g start date, e n d date  
a n d preferre d ter m .  
•  T he pre vi o us ra di ot hera p y listi n g will c o ntai n c o h ort, partici pa nt i de ntifier, a ge, se x, race, start 
date, e n d date, l ocati o n of ra di ot hera p y, si de a n d l o be if l ocati o n is l u n g, t otal d ose, n u m ber of 
fracti o ns a n d best res p o nse o n t he treat me nt re gi me n. T his listi n g will be s orte d b y c o h ort, 
partici pa nt i de ntifier, ra di ot hera p y start date, ra di ot hera p y e n d date a n d l ocati o n.  
•  T he pre vi o us a ntica ncer s ur ger y listi n g will c o ntai n c o h ort, partici pa nt  i de ntifier, a ge, se x, race, 
date of s ur ger y, na me a n d l ocati o n of s ur ger y, c urati ve i nte nt of s ur ger y ( Y/ N), a n d o utc o me 
of s ur ger y. T his listi n g will be s orte d b y c o h ort, partici pa nt  i de ntifier, s ur ger y date, na me of 
s ur ger y a n d l ocati o n of s ur ger y . 
1 2. 2  
Pre vi o us a n d C o nc o mit a nt Me dic ati o ns   
Pre vi o us me dicati o ns are me dicati o ns, ot her t ha n st u d y i nter venti o n  a n d pre me dicati o ns f or st u d y 
i nter ve nti o n, w hic h starte d pri or t o first d ose date of st u d y i nter ve nti o n. In case t he date val ues 
will n ot all o w t o u ne q ui v ocall y all ocate a me dicati o n t o pre vi o us me dicati o n , t he me dicati o n will 
be c o nsi dere d as pre vi o us me dicati o n.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
3 8 /8 5  
 
 
C o nc o mita nt me dicati o ns  are me dicati o ns, ot her t ha n st u d y i nter ve nti o n a n d pre me dicati o ns f or 
st u d y i nter ve nti o n, w hic h are ta ke n b y partici pa nt s a n y ti me o n-treat me nt (see o n-treat me nt 
defi niti o n i n Secti o n 9 ), me dicati o ns ta ke n o n t he first da y of st u d y i nter ve nti o n will be c o nsi dere d 
o n -treat me nt. I n case t he date val ues clearl y i n dicate t hat t he me dicati o n ca n n ot be all ocate d t o 
pre vi o us me dicati o n a n d d o n ot  all o w t o u ne q ui v ocall y all ocate it t o c o nc o mita nt me dicati o n, t he 
me dicati o n will be c o nsi dere d as c o nc o mita nt me dicati o n.  
Pre vi o us a n d co nc o mita nt me dicati o ns  will be s u m marize d fr o m t he “ C o nc o mita nt M e dicati o n 
D etails” e C R F. A nat o mical T hera pe utic C he mical ( A T C )-2 n d le vel a n d preferre d ter m will be 
ta b ulate d as gi ve n fr o m t he W H O-D D  dicti o nar y c urre nt versi o n . I n case m ulti ple A T C’s are 
assi g ne d t o a dr u g, all A T C -2 n d le vel will be use d f or re p orti n g.  
A partici pa nt  will be c o u nte d o nl y o nce wit hi n a gi ve n dr u g class  a n d wit hi n a gi ve n dr u g na me, 
e ve n if he/s he recei ve d t he sa me me dicati o n at differe nt ti mes. T he s u m mar y will be s orte d b y 
Dr u g Class a n d Preferre d Ter m i n al p ha betical or der.  
Pre vi o us a n d C o nc o mita nt me dicati o ns will be prese nte d i n a listi n g i ncl u di n g  c o h ort, partici pa nt 
i de ntifier, a ge, se x, race, preferre d ter m a n d me dicati o n na me as pr o vi de d b y t he I n vesti gat or, start 
date /ti me, e n d date/ti me, d ose, d ose u nits, fre q ue nc y, r o ute, i n dicati o n, reas o n f or t he me dicati o n. 
A fla g will be a d de d t o i de ntif y  me dicati o ns as pre vi o us o nes a n d c o nc o mita nt o nes. T his listi n g 
will be s orte d b y c o h ort, partici pa nt i de ntifier, start date  a n d ti me , e n d date a n d ti me ( n ote t hat 
missi n g e n d date are c o nsi dere d as o n g oi n g a n d will be dis pla ye d after n o n -missi n g date i n case 
of sa me start date) , a n d preferre d ter m.  
1 2. 3  
C o nc o mit a nt  Pr oce d ures   
C o nc o mita nt  pr oce d ures  u n derta ke n a n y ti me o n trial, are c ollecte d u n der  t he eC R F pa ge 
“ C o nc o mita nt  Pr oce d ures  D etails”.  
C o nc o mita nt pr oce d ures will be prese nte d i n a listi n g i ncl u di n g c o h ort, partici pa nt  i de ntifier, a ge, 
se x, race, na me of pr oce d ure (as pr o vi de d b y t he In vesti gat or), start date, e n d date, i n dicati o n, a n d 
reas o n f or pr oce d ure. A fla g will be a d de d t o i de ntif y eac h pr oce d ure as pri or t o treat me nt or after 
t he o n -treat me nt peri o d . T he listi n g will be s orte d b y c o h ort, partici pa nt i de ntifier, start date, e n d 
date ( n ote t hat missi n g e n d date are c o nsi dere d as o n g oi n g a n d will be dis pla ye d a fter n o n-missi n g 
date i n case of sa me start date) a n d pr oce d ure na me.  
1 2. 4  
S u bse q ue nt A ntic a ncer Tre at me nt   
S u bse q ue nt 
a ntica ncer  treat me nt is c ollecte d 
u n der t he “ A ntica ncer  T reat me nt after 
Disc o nti n uati o n  D etails”, “ Ra di ot hera p y after Disc o nti n uati o n D etails” ( N ote: Ra di ot hera p y d o ne 
w hile partici pa nt is still recei vi n g st u d y i nter ve nti o n is n ot c o nsi dere d s u bse q ue nt a ntica ncer 
treat me nt.) a n d “ S ur geries after Disc o nti n uati o n  D etails” e C R F pa ges.  
S u bse q ue nt a ntica ncer treat me nt will be prese nte d i n a listi n g i ncl u di n g c o h ort, partici pa nt  
i de ntifier, a ge, se x, race, preferre d ter m/ me dicati o n na me, treat me nt t y pe ( me dicati o n or 
ra di ot hera p y or sur ger y) , re gi me n na me (if me dicati o n), best res p o nse (if me dicati o n), start date, 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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I N F O R M A T I O N 
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e n d date  (if 
me dicati o n or ra di ot hera p y), ra di ot hera p y site/ na me of s ur ger y/l ocati o n (if 
ra di ot hera p y or s ur ger y). T his listi n g will be s orte d b y c o h ort, partici pa nt  i de ntifier, start date, e n d 
date, treat me nt ty pe , preferre d ter m a n d me dicati o n na me .  
1 2. 5  
Pre me dic ati o ns   
Pre me dicati o ns are me dicati o ns a d mi nistere d per pr ot oc ol pri or t o st u d y i nter ve nti o n.  
Pre me dicati o n f or bi ntraf us p alfa will be base d o n “ Pre me dicati o n 
M 7 8 2 4” e C R F pa ge 
( partici pa nts f or w h o m t he q uesti o n “ Has t he partici pa nt recei ve d pre me dicati o ns bef ore M 7 8 2 4 
i nf usi o n?” is a ns were d “ Yes” at t he c orres p o n di n g visit). Pre me dicati o n f or c he m ot hera p y will be 
base d o n “ Pre me dicati o n c he m ot hera p y” e C R F pa ge ( partici pa nts f or w h o m t he q uesti o n “ Has t he 
partici pa nt recei ve d pre me dicati o ns bef ore c he m ot hera p y i n f usi o n?” is a ns were d “ Yes” at t he 
c orres p o n di n g visit).  
A listi n g of pre me dicati o n f or bi ntraf us p alfa a n d a listi n g of pre me dicati o n f or c he m ot hera p y will 
be pr o vi de d. T heses listi n gs will i ncl u de c o h ort, partici pa nt i de ntifier, a ge, se x, race, na me of 
me dicati o n, start date/ti me of pre me dicati o n, e n d date/ti me of pre me dicati o n, st u d y da ys si nce t he 
first st u d y i nter ve nti o n, d ose, u nit, r o ute. T hese listi n gs will be s orte d b y c o h ort, partici pa nt 
i de ntifier, start date/ti me of pre me dicati o n , e n d date/ti me of pre me dicati o n a n d me dicati o n na me.  
1 3  
St u d y Inter ve nti o n C o m pli a nce a n d E x p os ure   
S u m maries will be perf or me d o n S A F A nal ysis S et b y c o h ort  a n d c o m bi ne d 1 L C o h ort A, B, C .  
A d mi nistrati o n details of bi ntraf us p alfa a n d ot her st u d y i nter ve nti o ns are gi ve n i n Secti o n 6 of t he 
pr ot oc ol.  
D ur ati o n of 
T her a p y ( W ee ks) a n d N u m ber of Inf usi o ns  f or B i ntr af us p alf a a n d 
C he m ot her a p y  
All d urati o n of treat me nt a n d n u m ber of i nf usi o ns s u m maries will be base d o n “ M 7 8 2 4 
A d mi nistrati o n 
Details” , “ Cis plati n 
A d mi nistrati o n 
Details”, “ Car b o plati n 
A d mi nistrati o n 
Details”, “ Pe metre xe d A d mi nistrati o n Details”, 
“ Paclita xel A d mi nistrati o n Details”, “ Na b -
paclita xel 
A d mi nistrati o n 
Details”, 
“ Ge mcita bi ne 
A d mi nistrati o n 
Details”, 
“ D oceta xel 
A d mi nistrati o n Details” e C R F pa ge .  
Bi ntraf us p alfa , cis plati n, car b o plati n, pe metre xe d, paclita xel a n d d oceta xel are a d mi nistere d e ver y 
3 wee ks. T he d urati o n of t hera p y (i n wee ks) f or eac h of t hese treat me nts is defi ne d as:  
d urati o n of t hera p y = ( date of last d ose of t h er a p y - date of first d ose of t h er a p y + 2 1
7
)  
Na b -paclita xel is a d mi nistere d i n a 3 -wee k c ycle o n Da y 1, 8, a n d 1 5, i n eac h c ycle. W het her t he 
partici pa nt rei nitiates t he treat me nt or n ot, t he d urati o n of t hera p y (i n wee ks) f or t his treat me nt is 
defi ne d as:  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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C O N F I D E N T I A L  
I N F O R M A T I O N 
4 0 /8 5  
 
 
d urati o n of na b -paclita xel t hera p y = ( date of last d ose of na b-paclita xel -date of first d ose of na b -paclita xel + 7
7
)  
Ge mcita bi ne is a d mi nistere d i n a 3 -wee k c ycle o n Da y 1, a n d 8 i n eac h c ycle. W het her t he 
partici pa nt rei nitiates t he treat me nt or n ot, the d urati o n of t hera p y (i n wee ks) f or t his treat me nt  is 
defi ne d as:  
d urati o n of ge mcita bi ne t hera p y = ( date of last d ose of ge mcita bi ne -date of first d ose of ge mcita bi ne + 1 4
7
)  
W het her t he partici pa nt rei nitiates t he treat me nt or n ot, t he d urati o n of t he c he m ot hera p y 
c o m bi nati o ns   
(cis plati n /pe metre xe d,   
car b o plat i n/pe metre xe d,   
car b o plati n/ paclita xel, 
car b o plati n/na b -paclita xel, cis plati n /ge mcita bi ne, car b o plati n /ge mcita bi ne ) will als o be defi ne d as 
f oll o ws:  
d urati o n of c h e m ot hera p y c o m bi n ati o n = ( date of last d ose of c h e m o-date of first d ose of c he m o + 2 1
7
)  
A n i nf usi o n is re gar de d t o be recei ve d, if t he act ual d ose recei ve d is > 0 m g . 
T he f oll o wi n g s u m mar y ta bles will be pr o vi de d:  
•  D urati o n of t hera p y ( wee ks) f or eac h treat me nt ( bi ntraf us p alfa , cis plati n, car b o plati n, 
pe metre xe d, 
paclita xel, 
na b -paclita xel, 
ge mc ita bi ne, 
d oceta xel, a n d 
c he m ot hera p y 
c o m bi nati o ns ) 
•  N u m ber of i nf usi o ns recei ve d f or eac h treat me nt ( bi ntraf us p alfa , cis plati n, car b o plati n, 
pe metre xe d, paclita xel, na b -paclita xel, ge mcita bi ne, d oceta xel)  
Bi ntr af us p alf a a n d C he m ot her a p y C u m ul ati ve D ose, D ose Inte nsit y, R el ati ve D ose Inte nsit y  
Bi ntraf us p alfa a n d c he m ot hera p y  d osi n g calc ulati o ns a n d s u m maries will be base d o n “ M 7 8 2 4 
A d mi nistrati o n 
Details”, 
“ Cis plati n 
A d mi nistrati o n 
Details”, “ Car b o plati n 
A d mi nistrati o n 
Details”, “ Pe metre xe d A d mi nistrati o n 
Details”, “ Paclita xel A d mi nistrati o n Details”, “ Na b -
paclita xel 
A d mi nistrati o n 
Details”, 
“ Ge mcita bi ne 
A d mi nistrati o n 
Details”, 
“ D oceta xel 
A d mi nistrati o n Details” e C R F pa ge s. A d ose is re gar de d t o be a d mi nistere d, if t he act ual d ose 
recei ve d is > 0 m g . 
C u m ulati ve d ose ( m g/ m²) = s u m o ver all visits d uri n g  t he ti me peri o d of [act ual d ose ( m g) recei ve d 
at visit i / b o d y s urface area [ B S A] ( m²) at visit i], w here: 
B S A at a visit  i ( m²) = √( h ei g ht at B aseli ne (c m) * wei g ht at visit i ( k g) 
3 6 0 0
)  
T he c u m ulati ve d ose of car b o plati n recei ve d i n a ti me peri o d will be fi rst calc ulate d i n m g as t he 
s u m of t he act ual d ose le vels ( m g) t hat t he partici pa nt recei ve d wit hi n t hat peri o d ( directl y 
c ollecte d i n t he e C R F).  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
4 1 /8 5  
 
 
T he c u m ulati ve d ose of car b o plati n will als o be c o m p ute d i n m g. mi n/ m L usi n g t he Cal vert 
e q uati o n as f oll o ws:  
C u m ulati ve d ose ( m g. mi n/ m L) = s u m o ver all visits d uri n g t he ti me peri o d of [act ual d ose ( m g) 
recei ve d at visit i / ( Gl o mer ular Filtrati o n Rate [ G F R] at visit i + 2 5)], w here G F R is esti mate d b y 
calc ulate d creati ni ne cleara nce ( Cr Cl) usi n g t he C oc kcr oft -Ga u lt e q uati o n: 
Esti mate d G F R ( m L/ mi n) = Cr Cl = (( 1 4 0 - a ge ( years)) * wei g ht ( k g) * ( 0. 8 5 f or fe males o nl y)) / 
( 7 2 * creati ni ne ( m g/ d L)) 
C o n versi o n fact or f or creati ni ne: 1 m g/ d L = 8 8. 4 µ m ol/ L.  
T he G F R val ue will be ca p pe d at 1 2 5 m L/ mi n.  
I n case t he wei g ht or creati ni ne is n ot a vaila ble at a visit, it will be i m p ute d t o t he last o bser ve d 
val ue . 
T he c u m ulati ve d ose of bi ntraf us p alfa per partici pa nt i n a ti me peri o d is t he s u m of t he act ual d ose 
le vels of  bi ntraf us p alfa  t hat t he partici pa nt recei ve d wit hi n t hat peri o d (i.e. , t otal d ose a d mi nistere d 
[ m g]). 
T he d ose i nte nsit y ( DI)  of c he m ot hera p y  (m g/ m² /c ycle) (e xcl u di n g car b o plati n) per 3 -wee k peri o d 
is defi ne d as: 
DI = (
cu m ulati ve d ose  ( m g / m²)
( d urati o n of t hera p y (i n wee ks))/ 3)  
T he DI of car b o plati n ( m g. m i n/ m L/c ycle) per 3-wee k peri o d is defi ne d as:  
DI = ( 𝑐u m ulati ve d ose  (𝑚𝑔.𝑚𝑖𝑛/ 𝑚𝐿)
( d urati o n of t hera p y (i n wee ks))/ 3)  
T he DI of bi ntraf us p alfa ( m g/c ycle) per 3-wee k peri o d is defi ne d as:  
DI = (
cu m ulati ve d ose  (m g ) 
( d urati o n of t hera p y (i n wee ks))/ 3)  
F or partici pa nts w h o rei nitiate d bi ntraf us p alfa d uri n g t he st u d y, f or m ula a b o ve will als o a p pl y.  
T he relati ve d ose i nte nsit y ( R DI) of bi ntraf us p alfa is defi ne d as t he act ual d ose i nte nsit y di vi de d 
b y t he pla n ne d d ose per c ycle  ( 2 4 0 0 m g) a n d e x presse d i n perc e nta ge. 
R DI ( %) = 1 0 0 * (
DI
pla n ne d d ose per c ycle )  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
4 2 /8 5  
 
 
T he R DI of c he m ot hera p y a ge nts ( %) is defi ne d as f oll o ws: R DI ( %) = 1 0 0 * ( DI / pla n ne d DI), 
w here t he pla n ne d DI ( m g/ m²/c ycle or A U C m g. mi n/ m L/c ycle) de pe n ds o n eac h c he m ot hera p y 
a d mi nistrati o n sc he d ule a n d is defi ne d as f oll o ws: 
( na b-paclita xel) pla n ne d d ose at wee k 1 da y 1 ( m g/ m²) * 3  
( ge mcita bi ne) pla n ne d d ose at wee k 1 da y 1 ( m g/ m²) * 2 
(all ot her c he m ot hera pies) pla n ne d d ose at wee k 1 da y 1 ( m g/ m² or A U C) 
T he f oll o wi n g s u m mar y ta bles will be  pr o vi de d:  
•  C u m ulati ve d ose f or bi ntraf us p alfa ( m g) a n d eac h c he m ot hera p y  ( m g/ m² or A U C ) (cis plati n, 
car b o plati n, pe metre xe d, paclita xel, na b -paclita xel, ge mcita bi ne, d oceta xel)  
•  D ose i nte nsit y f or bi ntraf us p alfa ( m g/c ycle) a n d eac h c he m ot hera p y  ( m g/ m²/c ycle or 
m g. mi n/ m L/c ycle ) (cis plati n, car b o plati n, pe metre xe d, paclita xel, na b -paclita xel, ge mcita bi ne, 
d oceta xel)  
•  Relati ve d ose i nte nsit y ( %)  f or bi ntraf us p alfa a n d eac h c he m ot hera p y (cis plati n, car b o plati n, 
pe metre xe d, paclita xel, na b -paclita xel, ge mcita bi ne, d oceta xel) : < 8 0 % / [ 8 0 %-9 0 %]  / > 9 0 %.  
C he m ot her a p y D ose Re d ucti o ns  
C he m ot hera p y d ose re d ucti o ns as rec or de d o n t he “ Cis plati n 
A d mi nistrati o n 
Details” , 
“ Car b o plati n 
A d mi nistrati o n 
Details”, “ Pe metre xe d 
A d mi nistrati o n 
Details”,  “ Paclita xel 
A d mi nistrati o n Details”,  “ Na b-paclita xel A d mi nistrati o n Details”, “ Ge mcita bi ne A d mi nistrati o n 
Details”, “ D oceta xel A d mi nistrati o n Details” pa ge s of t he e C R F (i.e. , a ns wer t o t he q uesti o n “Is 
t here a c ha n ge i n d ose?” = “ D ose a dj uste d”) will be use d f or a nal ysis. N u m ber of partici pa nt s wit h 
at least o ne d ose re d ucti o n, reas o ns f or d ose re d ucti o n, as well as a cate g orizati o n of t he n u m ber 
of i nf usi o n wit h d ose re d uce d ( 1 / 2 / ≥ 3) will be s u m marize d.  
S u m mar y ta bles will be pr o vi de d f or eac h c he m ot hera p y (cis plati n, car b o plati n, pe metre xe d, 
paclita xel, na b -paclita xel, ge mcita bi ne, d oceta xel).  N o d ose re d ucti o n is all o we d f or bi ntraf us p 
alfa.  
Bi ntr af us p alf a a n d C he m ot her a p y T her a p y Del a ys  
Bi ntraf us p alfa , cis plati n, car b o plati n, pe metre xe d, paclita xel a n d d oceta xel are a d mi nistere d e ver y 
3 wee ks. Dela ys of t hera p y f or eac h of t hese treat me nts will be deri ve d b y i nf usi o n as t he n u m ber 
of da ys si nce t he start of last i nf usi o n –  2 1.  
Na b -paclita xel is a d mi nistere d i n a 3 -wee k c ycle o n Da y 1, 8, a n d 1 5 , i n eac h c ycle. Dela ys of 
t hera p y f or na b-paclita xel will be deri ve d b y i nf usi o n as t he n u m ber of da ys si nce t he start of last 
i nf usi o n –  7.  
Ge mcita bi ne is a d mi nistere d i n a 3 -wee k c ycle o n Da y 1, a n d 8, i n eac h c ycle. Dela ys of t hera p y 
f or ge mcita bi ne will be deri ve d b y i nf usi o n as t he n u m ber of da ys si nce t he start of last i nf usi o n –  
7 if t he last i nf usi o n was t he first i nf usi o n wit hi n a c ycle, ot her wise as t he n u m ber of da ys si nce 
t he start of last i nf usi o n –  1 4.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
4 3 /8 5  
 
 
If t he val ue a b o ve is > 0 da ys, t he n t his will be classe d as a dela y. A partici pa nt  ma y ha ve m ore 
t ha n o ne treat me nt dela y t hr o u g h o ut t he c o urse of treat me nt. 
T he f oll o wi n g will be s u m marize d i n a ta ble:  
•  N u m ber of partici pa nt s wit h at least o ne dela y 
•  L o n gest dela y  per partici pa nt  ( n o dela y, 1-2 da ys, 3 -8 da ys, 9 -1 5 da ys, ≥1 6 da ys)  
•  N u m ber of dela ys per partici pa nt  ( 0 dela y, 1 dela y, 2 dela ys, 3 dela ys, ≥ 4 dela ys). 
S u m mar y ta bles will be pr o vi de d  f or eac h treat me nt (bi ntraf us p alfa , cis plati n, car b o plati n, 
pe metre xe d, paclita xel, na b -paclita xel, ge mcita bi ne, d oceta xel) . 
A listi n g of treat me nt e x p os ure t o bi ntraf us p alfa will be pr o vi de d. It will i ncl u de c o h ort, 
partici pa nt  i de ntifier, a ge, se x, race, c u m ulati ve d ose, d ose i nte nsit y,  relati ve d ose i nte nsit y, visit, 
i nf usi o n start date a n d ti me, i nf usi o n e n d date a n d ti me, c ha n ge i n d ose a n d reas o n f or c ha n ge, 
i nf usi o n rate ( m L/ hr), act ual d ose ( m g), r o ute, a d mi nistrati o n m o dificati o n a n d reas o n f or 
m o dificati o n, c ha n ge i n a d mi nistrati o n detail , treat me nt dela y ( da ys). I nf usi o ns d uri n g t he 
rei nitiati o n p hase will be fla g ge d i n t he listi n g. T h is listi n g will be s orte d b y c o h ort, partici pa nt  
i de ntifier, i nf usi o n start date a n d i nf usi o n e n d date.  
A listi n g of treat me nt e x p os ure t o n a b-p aclita xel, a listi n g of treat me nt e x p os ure t o paclita xel, a 
listi n g of treat me nt e x p os ure t o car b o plati n, a listi n g of treat me nt e x p os ure t o cis plati n, a listi n g of 
treat me nt e x p os ure t o g e mcita bi ne, a listi n g of treat me nt e x p os ure t o p e metre xe d a n d a listi n g of 
treat me nt e x p os ure t o d oceta xel will be pr o vi de d. T he y will i ncl u de c o h ort , partici pa nt  i de ntifier, 
a ge, se x, race, c u m ulati ve d ose, d ose i nte nsit y, relati ve d ose i nte nsit y,  visit, i nf usi o n start date a n d 
ti me, i nf usi o n e n d date a n d ti me, c ha n ge i n d ose a n d reas o n f or c ha n ge, i nf usi o n rate ( m L/ hr), 
pla n ne d d ose ( m g), act ual d ose ( m g), r o ute, a d mi nistrati o n 
m o dificati o n a n d reas o n f or 
m o dificati o n, c ha n ge i n a d mi nistrati o n detail, tre at me nt dela y ( da ys). I nf usi o ns d uri n g t he 
rei nitiati o n p hase will be fla g ge d i n t hese listi n gs. T hese listi n gs will be s orte d b y c o h ort, 
partici pa nt  i de ntifier, i nf usi o n start date a n d i nf usi o n e n d date. 
C he m ot her a p y S witc h  
A listi n g of c he m ot hera p y s witc h  will als o be pr o vi de d  base d o n “ C he m ot hera p y S witc h” e C R F 
pa ge . S witc hes wit hi n c o h orts (fr o m o ne c he m ot hera p y t o a n ot her) a n d bet wee n c o h orts will be 
c o nsi dere d. T hese listi n g 
will i ncl u de c o h ort, partici pa nt  i de ntifier, a ge, se x, race, ne w 
c he m ot hera p y re gi me n, reas o n f or s witc h.  
1 4  
Effic ac y A n al yses   
If n ot state d ot her wise, e fficac y a nal yses will be prese nte d f or t he F A S b y c o h ort a n d  c o m bi ne d  
1 L C o h ort A, B, C  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
4 4 /8 5  
 
 
1 4. 1  
Pr i m ar y E n d p oi nt A n a lysis   
T he occ urre nce of treat me nt -e mer ge nt A Es a n d treat me nt -relate d A Es i ncl u di n g A E SIs as pri mar y 
e n d p oi nt  of t his st u d y  will be descri be d i n Secti o n 1 5 . 
1 4. 2  
Sec o n d ar y E n d p oi nt A n al ysis   
1 4. 2. 1   
C o nfir me d O bjecti ve Res p o nse A cc or di n g  t o R E CI S T 1. 1 as 
A ssesse d b y I n vesti g at or  
A sec o n dar y e n d p oi nt of t his st u d y is t he c o nfir me d o bjecti ve res p o nse .  
Best o verall res p o nse ( B O R) will be assesse d base d o n re p orte d o verall res p o nses at differe nt 
e val uati o n ti me p oi nts fr o m t he  date of first st u d y i nter ve nti o n u ntil d oc u me nte d disease 
pr o gressi o n i n acc or da nce t o R E CI S T v 1. 1, ta ki n g re q uire me nts f or c o nfir mati o n i nt o acc o u nt as 
detaile d bel o w. O nl y t u m or assess me nts perf or me d bef ore t he start of a n y s u bse q ue nt a nti -ca ncer 
t hera pies will be c o nsi dere d i n t he assess me nt of B O R. If a t u m or assess me nt was perf or me d o n 
t he sa me da y as start of ne w a nti-ca ncer t hera p y, it will be ass u me d t hat t he t u m or assess me nt was 
perf or me d pri or t o t he start of t he ne w a nti -ca ncer t hera p y, t heref ore  t he t u m or assess me nt will be 
i ncl u de d i n t he assess me nt of B O R. 
B O R b ase d o n co nfir me d res p o nses: 
•  C R = at least t w o deter mi nati o ns of C R at least 4 wee ks a part ( wit h n o P D i n bet wee n) 
•  P R = at least t w o deter mi nati o ns of P R or better ( P R f oll o we d b y P R or P R f oll o we d b y 
C R) at least 4 wee ks a part (a n d n ot q ualif yi n g f or a C R) , wit h n o P D i n bet wee n 
•  S D = at least o ne S D assess me nt  ( or better) ≥ 6  wee ks after t he first st u d y i nter ve nti o n (a n d 
n ot q ualif yi n g f or C R or P R)  
•  P D = P D ≤ 1 2 wee ks after t he first st ud y i nter ve nti o n (a n d n ot q ualif yi n g f or C R, P R or 
S D)  
•  N E = all ot her cases 
S D ca n f oll o w P R o nl y i n t he rare case t hat t u m or i ncreases b y less t ha n 2 0 % fr o m t he na dir, b ut 
e n o u g h t hat a pre vi o usl y d oc u me nte d 3 0 % decrease fr o m baseli ne n o l o n ger h ol ds.  If t his occ urs 
t he se q ue nce P R-S D -P R is c o nsi dere d a c o nfir me d P R.  A se q ue nce of P R –  S D –  S D –  P D w o ul d 
be a best res p o nse of S D if t he mi ni m u m d urati o n f or S D defi niti o n has bee n met.  
O bjecti ve res p o nse ( O R)  is defi ne d as a c o nfir me d B O R of C R  o r P R acc or di n g t o R E CI S T v 1. 1.  
Partici pa nts w h o d o n ot ha ve a n o n -treat me nt ra di o gra p hic t u m or assess me nt d ue t o earl y 
pr o gressi o n, w h o recei ve a nti -t u m or treat me nts ot her t ha n t he st u d y treat me nts pri or t o reac hi n g 
c o nfir me d C R or P R, or w h o die, pr o gres s, or dr o p o ut f or a n y reas o n pri or t o reac hi n g c o nfir me d 
C R or P R will be c o u nte d as n o n -res p o n ders i n t he assess me nt of O R. Eac h partici pa nt will ha ve 
a n o bjecti ve res p o nse stat us ( 0: ‘ n o O R’; 1: ‘ O R’).  O R rate ( O R R) is t he pr o p orti o n of partici pa nts 
wi t h O R i n t he a nal ysis set. 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
4 5 /8 5  
 
 
T he d ise ase co ntr ol rate  (D C R)  is defi ne d as t he pr o p orti o n of partici pa nts wit h a c o nfir me d best 
o verall res p o nse of  C R  or  P R, or S D o ut of t he t otal n u m ber of partici pa nts bel o n gi n g t o t he 
a nal ysis set of i nterest.  
T he n u m ber a n d perce nta ge of partici pa nts wit h c o nfir me d o bjecti ve res p o nse of C R, P R, S D, P D, 
a n d N E will be ta b ulate d.  
T w o se parate listi n gs of t u m or assess me nt data will be pr o vi de d.  
O ne will i ncl u de c o h ort, partici pa nt i de ntifier, a ge, se x, race, dates of first/l ast a d mi nistrati o n of 
eac h st u d y i nter ve nti o n, date of first s u bse q ue nt a ntica ncer t hera p y as a p plica ble, date of deat h as 
a p plica ble, visit, date(s) of i ma gi n g, descri pti o n of tar get lesi o ns ( descri pti o n, site, t y pe of lesi o n, 
assess me nt met h o d, l o n gest d ia meter or s h ort a xis, s plit/ mer ge d), n o n-tar get lesi o ns ( descri pti o n, 
site, t y pe of lesi o n, assess me nt met h o d, lesi o n stat us), a n d ne w lesi o ns ( descri pti o n, site, t y pe of 
lesi o n, assess me nt met h o d). T his will be s orte d b y c o h ort, partici pa nt i de ntifier, date of i ma gi n g, 
lesi o n t y pe (tar get, n o n-tar get, ne w lesi o ns) a n d lesi o n i de ntifier. 
T he sec o n d listi n g will i ncl u de c o h ort, partici pa nt i de ntifier, a ge, se x, race, dates of first/last 
a d mi nistrati o n of eac h st u d y i nter ve nti o n, date of first s u bse q ue nt a nt ica ncer t hera p y as a p plica ble, 
date of deat h as a p plica ble, visit, date(s) of i ma gi n g, res p o nse f or tar get lesi o ns, res p o nse f or n o n -
tar get lesi o ns, occ urre nce of ne w lesi o ns, s u m of lesi o n dia meters, perce nt c ha n ge i n tar get lesi o ns 
fr o m baseli ne a n d o verall res p o nse. N ote t hat res p o nse f or tar get a n d n o n -tar get lesi o ns is n ot 
a p plica ble at Baseli ne. T his will be s orte d b y c o h ort, partici pa nt i de ntifier a n d date of i ma gi n g.  
T he c o nfir me d O R R a n d t w o -si de d 9 5 % C o nfi de nce I nter vals ( CIs) usi n g t he Cl o p per-Pe ars o n 
met h o d (e xact CI f or a bi n o mial pr o p orti o n as c o m p ute d b y defa ult b y t he F R E Q pr oce d ure usi n g 
t he E X A C T o pti o n) will be pr o vi de d.  
A d diti o nall y, t he n u m ber a n d perce nta ge of partici pa nts wit h D C R wit h a t w o -si de d 9 5 % CI usi n g 
t he Cl o p per-Pears o n met h o d will be dis pla ye d.  
T his  a nal ysis will als o be c o n d ucte d o n t he s u bset of partici pa nts i n t he F A S w h o ha ve bee n  
f oll o we d f or at least 6 m o nt hs, i.e., data c ut-off date –  date of first a d mi nistrati o n + 1 ≥ 1 8 2 da ys.  
I n a d diti o n, a s u m mar y ta ble of t he reas o ns f or n o n-e val ua ble c o nfir me d best o verall res p o nse  will 
be pr o vi de d, t he f oll o wi n g reas o ns will be detaile d:  
•  N o baseli ne assess me nt  
•  N o p ost -baseli ne assess me nts d ue t o deat h wit hi n 6 wee ks after t he start of st u d y i nter ve nti o n  
•  N o p ost -baseli ne assess me nts d ue t o ot her reas o ns  
•  All p ost -baseli ne assess me nts ha ve o verall res p o nse ‘ N o n -e val ua ble’ 
•  Ne w a ntica ncer  t hera p y starte d bef ore first e val ua ble p ost -baseli ne assess me nt  
•  S D of i ns ufficie nt d urati o n ( < 6 wee ks after t he start of st u d y i nter ve nti o n)  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
4 6 /8 5  
 
 
N ote: special cases w here o bjecti ve res p o nse is N E d ue t o b ot h earl y S D a n d late P D will be 
classifie d i nt o t his cate g or y . 
•  P D t o o late (i.e. , t u m or assess me nt of P D was > 1 2 wee ks after start of st u d y i nter ve nti o n a n d 
t here was n o e val ua ble t u m or assess me nt i n bet wee n)  
A listi n g of reas o ns f or n o n -e val ua ble c o nfir me d best  o verall  res p o nse will als o be create d 
i ncl u di n g: partici pa nt i de ntifier, a ge, se x, race, c o h ort, date of first a n d last st u d y i nter ve nti o n, 
date(s) of i ma gi n g, date of first  s u bse q ue nt a nti-ca ncer t hera p y, date of deat h, o verall res p o nse a n d 
t he reas o n f or n o n-e val ua ble c o nfir me d best o verall  res p o nse. 
1 4. 2. 2   
S u b gr o u p A n al ysis f or C o n fir me d O bjecti ve Res p o nse  
T he O R R a nal ysis as descri be d i n 1 4. 2 . 1 will be c o n d ucte d i n t he s u b gr o u ps of partici pa nts defi ne d 
i n Secti o n 8. 2  c o nsi deri n g C o h ort A a n d c o m bi ne d 1 L C o h ort A, B, C o nl y.  T h ose s u b gr o u ps 
a nal yses will be s u p p orte d b y f orest pl ots.  
1 4. 2. 3   
Pr o gressi o n -Free S ur vi v al  A cc or di n g t o 
R E CI S T 1. 1 as 
A ssesse d b y I n vesti g at or   
A sec o n dar y e n d p oi nt of t his st u d y is p r o gressi o n-free sur vi val ( P F S ) acc or di n g t o R E CI S T 1. 1 
assesse d b y t he In vesti gat or. T he disease pr o gressi o n will be d oc u me nte d b y t he In vesti gat or i n 
t he e C R F acc or di n g t o R E CI S T versi o n 1. 1. 
P F S  ti me is defi ne d as t he ti me fr o m first st u d y i nter ve nti o n u ntil date of t he first d oc u me ntati o n 
of o bjecti ve P D or deat h d ue t o a n y ca use, w hic he ver occ urs first : 
P F S = ( date of P D or deat h/ce ns ori n g –  date of first st u d y i nter ve nti o n + 1)/ 3 0. 4 3 7 5 ( m o nt hs).  
T he f oll o wi n g ce ns ori n g r ules will be a p plie d f or t he P F S c o m p utati o n:  
•  A n y partici pa nt  wit h neit her assess me nt of t u m or pr o gressi o n, n or deat h date wit hi n 1 2 w ee ks, 
i.e., 8 4  da ys after last t u m or assess me nt ( or 2 4 wee ks, i.e., 1 6 8 da ys after 1 2 m o nt hs of f oll o w -
u p) or date of first st u d y i nter ve nti o n will be ce ns ore d o n t he date of last t u m or assess me nt or 
first st u d y i nter ve nti o n w hate ver is later  
•  If deat h wit ho ut pre vi o usl y d oc u me nte d P D is o bser ve d after m ore t ha n  1 2 wee ks after last 
t u m or assess me nt ( or 2 4 wee ks after 1 2 m o nt hs of f oll o w-u p) , t he partici pa nt  will be ce ns ore d 
at t he date of t he last e val ua ble t u m or assess me nt  
•  Partici pa nts w h o d o n ot ha ve a ba seli ne t u m or assess me nt or w h o d o n ot ha ve a n y p ost-baseli ne 
t u m or assess me nts will be ce ns ore d at t he date of first st u d y i nter ve nti o n u nless deat h occ urre d 
o n or bef ore t he ti me of t he sec o n d pla n ne d t u m or assess me nt (i.e. , 1 2 wee ks or  2 4 wee ks  after 
1 2 m o nt hs of f oll o w -u p ) i n w hic h case t he deat h will be c o nsi dere d a n e ve nt 
•  Partici pa nts w h o start ne w a ntica ncer treat me nt pri or t o a n e ve nt will be ce ns ore d o n t he date 
of t he last e val ua ble t u m or assess me nt bef ore a ntica ncer t hera p y is gi ve n  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
4 7 /8 5  
 
 
•  Partici pa nts w it h a n e ve nt after t w o or m ore s u bse q ue nt missi n g res p o nse assess me nts (i.e., n o 
assess me nts i n 1 2 wee ks or 2 4 wee ks  after 1 2 m o nt hs of f oll o w -u p ) will be ce ns ore d o n t he 
date of t he last e val ua ble t u m or assess me nt.  
Ce ns ori n g r ules are als o s u m marize d i n  Ta ble 4 . 
T a ble 4    
Ce ns ori n g R ules   
P F S E v e nt St at u s  
C e n s ori n g   
D at e of e v e nt / c e n s ori n g  
Pr o gr e s s e d or 
di e d  
 
Wit hi n t w o s u b s e q u e nt s c h e d ul e d 
t u m or a s s e s s m e nt s aft er l a st 
r e s p o n s e a s s e s s m e nt of C R, P R or 
S D  
E v e nt   
Mi ni m u m ( D at e of P D, D at e of 
d e at h)  
Ot h er wi s e  
C e n s or e d   
D at e of l a st t u m or a s s e s s m e nt wit h 
o ut c o m e C R, P R or S D or d at e of 
fir st st u d y i nt er v e nti o n , w h at e v er i s 
l at er 
N eit h er pr o gr e s s e d n or di e d  
C e n s or e d   
D at e of l a st t u m or a s s e s s m e nt wit h 
o ut c o m e C R, P R or S D or d at e of 
fir st st u d y i nt er v e nti o n , w h at e v er i s 
l at er 
T he last t u m or assess me nt date is defi ne d as t he last a vaila ble a n d e val ua ble t u m or assess me nt 
perf or me d pri or t o t he c ut off date ( or pri or t o e n d of st u d y, i.e. , partici pa nt s l ost t o f oll o w-u p or 
w h o wit h dra w c o nse nt) or pri or t o s u bse q ue nt a ntica ncer t hera p y. If n o e val ua ble t u m or 
assess me nt is a vaila ble, t his date will be t he date of first st u d y i nter ve nti o n. 
K a pl a n -Meier A n al ysis  
Ka pla n -Meier esti mates ( pr o d uct-li mit esti mates) a n d a s u m mar y of ass ociate d statistics will be 
prese nte d i ncl u di n g c orres p o n di n g t w o -si de d 9 5 % CIs. T he CIs f or t he me dia n will be calc ulate d 
acc or di n g t o Br o o k me yer a n d Cr o wle y ( 1 9 8 2) a n d CIs f or t he s ur vi val f u ncti o n esti mates a t 3, 6, 
9, 1 2 a n d 2 4 m o nt hs (if a p plica ble, f urt her s u bse q ue nt ti me p oi nts  will be c o nsi dere d) will be 
deri ve d usi n g t he l o g -l o g tra nsf or mati o n acc or di n g t o 
Kal bfleisc h a n d Pre ntice ( 1 9 8 0) 
( C O N F T Y P E =l o gl o g defa ult o pti o n i n S A S P R O C LI F E T E S T). T he esti mate of sta n dar d err or 
will be c o m p ute d usi n g Gree n w o o d’s f or m ula. A  Ka pla n -Meier  pl ot  will als o be dis pla ye d.  
Fre q ue nc y ( n u m ber a n d perce nta ge) of partici pa nt s wit h eac h e ve nt t y pe ( P D or deat h) a n d 
ce ns ori n g reas o ns will be prese nte d. Ce ns ori n g reas o ns are a s f oll o ws: 
•  O n g oi n g i n t he st u d y wit h o ut a n e ve nt  
•  N o baseli ne assess me nt  
•  N o e val ua ble p ost -baseli ne assess me nt  
•  Start of ne w a ntica ncer t hera p y  
•  E ve nt after 2 or m ore missi n g or n o n -e val ua ble p ost -baseli ne assess me nts  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
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•  Wit h dra wal of c o nse nt  
•  L ost t o f oll o w -u p  
L ost t o f oll o w -u p will i ncl u de t he f oll o wi n g partici pa nt s: 
•  Partici pa nts  declare d as l ost t o f oll o w -u p o n t he “ M 7 8 2 4 T er mi nati o n” or “ C he m ot hera p y 
T er mi nati o n” or “ St u d y T er mi nati o n” e C R F pa ges pri or t o t he a nal ysis c ut off ; 
•  Partici pa nts wit h t he last ali ve date > 1 4 wee ks pri or t o t he a nal ysis c ut off date ( d urati o n 
of 1 4 wee ks is base d o n t he assess me nt sc he d ule of e ver y 1 2 wee ks f or s ur vi val f oll o w -u p 
i nter val + 2 wee ks wi n d o w). 
•  T w o misse d/i na de q uate t u m or assess me nts pri or t o data c ut -off date  
T his a nal ysis will als o be c o n d ucte d o n t he s u bset of partici pa nts i n t he F A S w h o ha ve bee n 
f oll o we d f or at least 6 m o nt hs, i.e., data c ut-off date –  date of first a d mi nistrati o n + 1 ≥ 1 8 2 da ys.  
A listi n g of P F S acc or di n g t o R E CI S T 1. 1 assesse d b y In vesti gat or w ill be pr o vi de d wit h t he 
f oll o wi n g i nf or mati o n: c o h ort, partici pa nt  i de ntifier, a ge, se x, race, date of first st u d y i nter ve nti o n, 
date of last t u m or assess me nt, ce ns ore d ( y es/n o), date of e ve nt/ce ns ori n g, e ve nt/ce ns ori n g reas o n, 
ti me t o e ve nt. 
1 4. 2. 4   
O ver all S ur v i v al  
A sec o n dar y e n d p oi nt of t his st u d y is o verall sur vi val ( O S).  
O S  ti me is defi ne d as t he date fr o m t he first st u d y i nter ve nti o n t o deat h d ue t o a n y ca use:  
O S = ( date of e ve nt/ce ns ori n g –  date of first st u d y i nter ve nti o n + 1)/ 3 0. 4 3 7 5 ( m o nt hs).  
F or partici pa nt s ali ve at t he ti me of data c ut off date, w h o wit h dre w c o nse nt or w h o are l ost t o 
f oll o w u p, O S will be ce ns ore d at t he last date k n o w n t o be ali ve (see Secti o n 9. 6 ).  
T he date of e ve nt / ce ns ori n g is defi ne d i n  Ta ble 5 . 
T a ble 5    
S ur vi v al E ve nt / Ce ns ori n g   
S ur vi v al st at u s  
D at e of e v e nt / c e n s ori n g  
C e n s ori n g  
P arti ci p a nt s ali v e or l o st t o f oll o w-u p 
b ef or e or at c ut off d at e  
L a st d at e k n o w n t o b e ali v e  
Y e s  
P arti ci p a nt s w h o di e d b ef or e or at 
c ut off d at e  
D at e of d e at h  
N o  
T he a nal ysis of O S ti me will be perf or me d f oll o wi n g t he sa me a p pr oac h descri be d f or P F S i n 
Secti o n 1 4. 2. 3 . Ka pla n-Meier esti mates ( pr o d uct -li mit esti mates) will be prese nte d t o get her wit h 
a s u m mar y of ass ociate d statistics i ncl u di n g c orres p o n di n g t w o -si de d 9 5 % CIs. T he y will be 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
4 9 /8 5  
 
 
esti mate d at 1 2, 1 8, 2 4, 3 0, 3 6, 4 2, a n d 4 8 m o nt hs  (if a p plica ble, f urt her s u bse q ue nt ti me p oi nts  
will be c o nsi dere d) . 
Fre q ue nc y ( n u m ber a n d perce nta ge) of partici pa nt s wit h a n e ve nt ( deat h) a n d ce ns ori n g reas o ns 
will be prese nte d. Ce ns o ri n g reas o ns are as f oll o ws: 
•  A d mi nistrati ve ce ns ori n g  (ali ve at t he date of data c ut-off)  
•  N o n -a d mi nistrati ve ce ns ori n g  
N o n -a d mi nistrati ve ce ns ori n g i ncl u des:  
•  Partici pa nts w h o wit h dre w c o nse nt  
•  Partici pa nt s declare d as l ost t o f oll o w-u p o n t he “ M 7 8 2 4 ter mi nati o n” or “ C he m ot hera p y 
ter mi nati o n” or “ St u d y ter mi nati o n” e C R F pa ges pri or t o t he a nal ysis c ut off . 
•  Partici pa nts wit h t he last ali ve date > 1 4 wee ks pri or t o t he a nal ysis c ut off date ( d urati o n 
of 1 4 wee k s is base d o n t he assess me nt sc he d ule of e ver y 1 2 wee ks f or s ur vi val f oll o w-u p 
i nter val + 2 wee ks wi n d o w). A  Ka pla n -Meier pl ot  will als o be dis pla ye d.  
T his a nal ysis will als o be c o n d ucte d o n t he s u bset of partici pa nts i n t he F A S w h o were f oll o we d 
f or at least 6 m o nt hs, i.e., data c ut -off date –  date of first a d mi nistrati o n + 1 ≥ 1 8 2 da ys.  
A listi n g will pr o vi de t he f oll o wi n g i nf or mati o n: c o h ort, partici pa nt  i de ntifier, a ge, se x, race, date 
of first st u d y i nter ve nti o n, ce ns ore d ( y es/n o), date of e ve nt/ce ns ori n g, e ve nt/ce ns ori n g reas o n, a n d 
ti me t o e ve nt. 
1 4. 2. 5   
S u b gr o u p A n al ysis f or P F S a n d O S   
T he P F S a nal ysis  as descri be d i n 1 4. 2 .4  will be c o n d ucte d i n t he s u b gr o u ps of partici pa nts defi ne d 
i n Secti o n 8. 2  c o nsi deri n g C o h ort A a n d c o m bi ne d 1 L C o h ort A, B, C.  
T he O S a nal ysis as descri be d i n 1 4. 2. 5  will be c o n d ucte d i n t he s u b gr o u ps of partici pa nts defi ne d 
i n Secti o n 8. 2  c o nsi deri n g C o h ort A a n d c o m bi ne d 1 L C o h ort A, B, C.  
T h ose s u b g r o u ps a nal yses will be s u p p orte d b y f orest pl ots ( base d o n P F S a n d O S rates at 6-m o nt h 
a n d 1 2 -m o nt h).  
1 4. 2. 6   
S e nsiti vit y  A n al ysis f or P F S   
P F S c o u nti n g all e ve nts ( P D a n d deat h) re gar dle ss of t he start of a ne w a ntica ncer  t hera p y a n d 
i g n ori n g t he n u m ber of missi n g e val ua ble t u m or assess me nts bef ore pr o gressi o n or deat h will be 
c o nsi dere d a n d Ka pla n -Meier esti mates a n d a pl ot as descri be d i n Secti o n 1 4. 2. 3  will be pr o vi de d.  
1 4. 2. 7   
D ur ati o n of Res p o nse   
A sec o n dar y e n d p oi nt of t his st u d y is d urati o n of res p o nse ( D o R).  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
I N F O R M A T I O N 
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D o R  is defi ne d as t he ti me fr o m first d oc u me ntati o n of o bjecti ve res p o nse ( C R or P R) t o t he date 
of first d oc u me ntati o n of o bjecti ve pr o gressi o n of disease ( P D) or deat h d ue t o a n y ca use 
w hic he ver occ urs first. T he a nal ysis of D o R will be perf or me d o n c o nfir m e d o bjecti ve res p o nse 
of C R or P R acc or di n g t o R E CI S T 1. 1 as assesse d b y In vesti gat or. T he ce ns ori n g r ules f or D o R 
are as descri be d a b o ve f or P F S.  
D o R = ( date of P D or deat h/ce ns ori n g –  date of o bjecti ve res p o nse + 1)/ 3 0. 4 3 7 5 ( m o nt hs).  
T he a nal ysis of D o R will be perf or me d usi n g t he Ka pla n -Meier met h o d ( pr o d uct -li mit esti mates) 
a n d a s u m mar y of ass ociate d statistics will be prese nte d i ncl u di n g c orres p o n di n g t w o -si de d 9 5 % 
CIs. T he CIs f or t he me dia n will be calc ulate d acc or di n g t o Br o o k me yer a n d Cr o wle y ( 1 9 8 2) a n d 
CIs f or t he s ur vi val f u ncti o n esti mates at M o nt h 3, 6, 9, 1 2 a n d 2 4 (if a p plica ble, f urt her s u bse q ue nt 
ti me p oi nts  will be c o nsi dere d)  will be deri ve d usi n g t he l o g -l o g tra nsf or mati o n acc or di n g t o 
Kal bfleisc h a n d Pre ntice ( 1 9 8 0) ( C O N F T Y P E =l o gl o g def a ult o pti o n i n S A S P R O C LI F E T E S T). 
T he esti mate of sta n dar d err or will be c o m p ute d usi n g Gree n w o o d’s f or m ula.  
A Ka pla n -Meier pl ot will als o be dis pla ye d.  
T he ti me a n d d urati o n of res p o nse per partici pa nt  will als o be dis pla ye d i n a s wi m mer gra p h i n all 
pa rtici pa nts i ncl u de d i n t he F A S . T he le n gt h of t he bar will dis pla y t he ti me t o pr o gressi o n of 
disease/ deat h/last t u m or assess me nt. T he arr o w at t he e n d of t he bar will i n dicate a n o n g oi n g 
res p o nse (i.e., d urati o n of res p o nse ce ns ore d  a n d partici pa nt still at ris k ). T he first C R, P R a n d P D 
will be dis pla ye d o n t he gra p h, as well as t he first s u bse q ue nt a ntica ncer  t hera p y a n d t he e n d of 
st u d y i nter ve nti o n. Partici pa nts wit h dela ye d res p o nse will als o be s h o w n o n t he fi g ure.  
A listi n g w ill pr o vi de t he f oll o wi n g i nf or mati o n: c o h ort, partici pa nt  i de ntifier, a ge, se x, race, date 
of first st u d y i nter ve nti o n, date of first c o nfir me d res p o nse, ti me t o c o nfir me d res p o nse, date of 
last t u m or assess me nt, ce ns ore d (yes /n o ), date of e ve nt/ce ns ori n g, e ve nt/ce ns ori n g reas o n, D o R . 
1 4. 3  
F urt her E n d p oi nt A n al yses   
1 4. 3. 1   
F oll o w -u p Ti me f or P F S   
A Ka pla n -Meier a nal y sis will be perf or me d t o esti mate t he me dia n ti me of P F S f oll o w-u p d urati o n. 
T heref ore, t he P F S ce ns ori n g  i n dicat or as descri be d i n Ta ble 4  will be re verse d.  
Ka pla n -Meier esti mates will be prese nte d wit h t he me dia n ti me of f oll o w -u p f or P F S. I n partic ular, 
t he f oll o w-u p rate at 3, 6, 9, 1 2 a n d 2 4 m o nt hs (if a p plica ble, f urt her s u bse q ue nt ti me p oi nts  will 
be c o nsi dere d) will be esti mate d wit h c orres p o n di n g t w o -si de d 9 5 % CIs. 
A Ka pla n -Meier pl ot will als o be dis pla ye d.  
1 4. 3. 2   
F oll o w -u p Ti me f or O S   
A Ka pla n -Meier a nal ysis will be perf or me d t o esti mate t he me dia n ti me of O S f oll o w -u p d urati o n. 
T h eref ore, t he O S ce ns ori n g i n dicat or as descri be d i n Ta ble 5  will be re verse d.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
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C O N F I D E N T I A L  
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5 1 /8 5  
 
 
Ka pla n -Meier esti mates will be prese nte d wit h t he me dia n ti me of f oll o w -u p f or O S. I n partic ular, 
t he f oll o w-u p rate at 1 2, 1 8, 2 4, 3 0, 3 6, 4 2, a n d 4 8 m o nt hs  will be esti mate d wit h c orres p o n di n g 
t w o-si de d 9 5 % CIs. 
A Ka pla n -Meier pl ot will als o be dis pla ye d.  
1 4. 3. 3   
Pr o gressi o n -Free S ur vi v al 2   
A n e x pl orat or y  e n d p oi nt of t his st u d y is P F S 2  (disease pr o gressi o n  classifie d  acc or di n g t o R E CI S T 
1. 1 ) assesse d b y In vesti gat or.  
P F S 2  ti me is defi ne d as t he ti me fr o m first st ud y i nter ve nti o n t o o ne of t he f oll o wi n g t w o e ve nts, 
w hic he ver occ urs first:  
•  Assess me nt of P D b y In vesti gat or (ra di o gra p hic a n d/ or s y m pt o matic) after t he start of first 
s u bse q ue nt a ntica ncer t hera p y, usi n g eit her t he date of t u m or assess me nt fr o m “ Pr o gressi o n 
Stat us o n First S u bse q ue nt A nti -Ca ncer Treat me nt ” e C R F f or m, or t he date of assess me nt fr o m 
“Assess me nt of Disease base d o n I ma gi n g (acc or di n g t o R E CI S T 1. 1) - S u bse q ue nt A nti -
Ca ncer Treat me nt ” e C R F f or m w hate ver c o mes first 
or  
•  Deat h d ue t o a n y ca use ( n ote t hat deat h will be c o nsi dere d as e ve nt als o if partici pa nt di d  n o t 
recei ve s u bse q ue nt a ntica ncer t hera p y, or if t he deat h occ urs o utsi de t he first s u bse q ue nt 
a ntica ncer t hera p y peri o d).  
P F S 2 will be defi ne d as f oll o ws a n d re p orte d i n m o nt hs:  
P F S 2 = ( date of t he d oc u me ntati o n of P D after t he start of first s u bse q ue nt a ntica ncer t hera p y or 
deat h /ce ns ori n g –  date of first st u d y i nter ve nti o n + 1)/ 3 0. 4 3 7 5 ( m o nt hs).  
T he f oll o wi n g ce ns ori n g r ules will be a p plie d f or t he P F S 2 c o m p utati o n:  
•  Partici pa nts ali ve a n d w h o di d  n o t recei ve a first s u bse q ue nt a ntica ncer t hera p y will be 
ce ns ore d at t he last e val ua ble P F S assess me nt date  
•  Partici pa nts w h o recei ve d a first s u bse q ue nt a ntica ncer t hera p y a n d w h o di d n ot e x perie nce a n 
e ve nt ( P D or deat h) will be ri g ht -ce ns ore d o n t he date of last e val ua ble t u m or assess me nt. 
T he a nal ysis of P F S 2 will be perf or me d usi n g t he sa me a p pr oac h as descri be d f or P F S i n Secti o n 
1 4. 2. 3 . Ka pla n-Meier esti mates ( pr o d uct -li mit esti mates) will be prese nte d t o get her wit h a 
s u m mar y of ass ociate d statistics i ncl u di n g c orres p o n di n g t w o-si de d 9 5 % CIs. T he y will be 
esti mate d at 3, 6, 9, 1 2, a n d 2 4 m o nt hs  (if a p plica ble, f urt her s u bse q ue nt ti me p oi nts will be 
c o nsi dere d) . 
A Ka pla n -Meier pl ot  of  P F S 2 will als o be dis pla ye d.  
A listi n g will pr o vi de t he f oll o wi n g i nf or mati o n: c o h ort, partici pa nt  i de ntifier, a ge, se x, race, date 
of first st u d y i nter ve nti o n, date of first s u bse q ue nt a ntica ncer t hera p y a d mi nistrati o n, date of last 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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t u m or assess me nt, ce ns ore d ( y es/n o), date of e ve nt/ce ns ori n g, e ve nt/ce ns ori n g reas o n, a n d ti me t o 
e ve nt. 
1 4. 3. 4   
Ti me t o Res p o nse   
T he ti me t o res p o nse ( Tt R) will be calc ulate d f or eac h partici pa nt wit h a c o nfir me d res p o nse 
acc or di n g t o R E CI S T 1. 1 as t he ti me fr o m first st u d y i nter ve nti o n u ntil first o bser vati o n of 
res p o nse as deter mi ne d b y t he i n vesti gat or .  
Tt R  = ( date of C R or P R –  date of first st u d y i nter ve nti o n + 1)/ 3 0. 4 3 7 5 ( m o nt hs).  
Descri pti ve statistics of Tt R  a n d a s wi m mer pl ot ( descri be d u n der secti o n 1 4. 2. 7 ) s h o wi n g Tt R, 
D o R a n d w het her t he res p o nse was c o m plete or partial will be pr o vi de d.   
A partici pa nt listi n g will pr o vi de t he f oll o wi n g i nf or mati o n: c o h ort, partici pa nt i de ntifier , a ge, se x, 
race, date of first st u d y i nter ve nti o n, date of res p o nse, a n d ti me t o res p o nse. 
1 4. 3. 5   
T u m or S hri n k a ge i n T ar get Lesi o ns   
T u m or s hri n ka ge i n tar get lesi o ns will be meas ure d as t he perce nt c ha n ge i n s u m of dia meters of 
tar get lesi o ns acc or di n g t o R E CI S T 1. 1 criteria as assesse d b y In vesti gat or. T he s u m of dia meters 
will i ncl u de all tar get lesi o ns (l o n gest dia meter f or n o n -n o dal lesi o ns a n d s h ort a xis f or n o dal tar get 
lesi o ns).  
T he s hri n ka ge i n t he s u m of dia meters fr o m baseli ne will be dis pla ye d f or vali d ti me p oi nt 
assess me nts, o nl y. F or t he p ur p ose  of t his a nal ysis, a vali d ti me p oi nt assess me nt is defi ne d as a 
c o m plete assess me nt of all tar get lesi o ns re p orte d at B aseli ne a n d at least a p ost -baseli ne 
assess me nt. 
F or t he t u m or s hri n ka ge i n tar get lesi o ns e val uati o n, all t u m or assess me nts perf or me d u p  t o start 
of s u bse q ue nt a ntica ncer t hera p y, or c ut off date ( w hic he ver c o mes first) will be c o nsi dere d.  
F oll o wi n g pl ots will be pr o vi de d:  
o  Waterfall pl ot wit h stac ke d bars s h o wi n g t he s hri n ka ge perce nta ge at first sca n a n d t he 
ma xi m u m s hri n ka ge  si nce baseli ne, i.e. , t he perce nt c ha n ge i n t he s u m of dia meters 
bet wee n baseli ne a n d t he best p ost -baseli ne assess me nt i n t he ti mefra me descri be d a b o ve  
o  S pi der pl ot prese nti n g t he perce nt c ha n ge fr o m baseli ne f or eac h assess me nt a n d partici pa nt  
1 4. 3. 6   
Br ai n Lesi o ns   
A brai n 
C o m p ute d T o m o gra p h y/ Ma g netic Res o na nce I ma gi n g  (C T/ M RI ) sca n s h o ul d be 
perf or me d at B aseli ne, a n d s u bse q ue ntl y if cli nicall y i n dicate d b y de vel o p me nt of ne w s pecific 
s y m pt o ms. 
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Bas e d o n t he “ Brai n I ma gi n g” e C R F pa ge, a listi n g will pr o vi de t he f oll o wi n g i nf or mati o n: c o h ort, 
partici pa nt  i de ntifier, a ge, se x, race, date of first st u d y i nter ve nti o n, assess me nt visit, date of 
C T/ M RI sca n perf or me d, t u m or lesi o ns f o u n d ( Y/ N) a n d assess me nt met h o d, s orte d b y c o h ort, 
partici pa nt  i de ntifier, assess me nt visit. 
1 4. 3. 7   
Del a ye d Res p o nse  after I niti al Pr o gressi o n   
A dela ye d res p o nse will be  defi ne d as a d oc u me nte d o bjecti ve res p o nse [ C R or P R] t hat occ urre d 
after t he i nitial pr o gressi o n of disease. F or t h ose partici pa nts , the d urati o n of dela ye d res p o nse  
( D o D R) will be  defi ne d as:  
D o D R = ( date of e n d of res p o nse –  date of o bjecti ve  res p o nse + 1)/ 3 0. 4 3 7 5 ( m o nt hs).  
wit h e n d of res p o nse bei n g t he earliest date bet wee n P D occ urri n g after res p o nse, deat h, start of 
ne w a ntica ncer treat me nt or c ut -off date.  
Partici pa nts ha vi n g a dela ye d res p o nse will be fla g ge d i n t he listi n g of t u m or assess me nt a n d 
o verall res p o nse per R E CI S T assesse d b y i n vesti gat or descri be d u n der secti o n 1 4. 2. 1 . 
A listi n g of d urati o n of res p o nse f or partici pa nts ha vi n g a dela ye d res p o nse will be pr o vi de d 
i ncl u di n g: c o h ort, partici pa nt i de ntifier, a ge, se x, race, date of first st u d y i nter ve nti o n, date/st u d y 
da y of  first P D, date/st u d y da y of  first res p o nse ( C R or P R), o n g oi n g res p o nse at c ut off date 
( Y/ N), date/st u d y da y of e n d of res p o nse (wit h reas o n f or e n d of res p o nse bei n g P D, deat h, ne w 
a ntica ncer treat me nt , c ut-off ), d urati o n of dela ye d  res p o nse. 
1 4. 3. 8   
T u m or Res p o nse as A dj u dic ate d b y I R C   
If dee me d a p pr o priate b y t he st u d y tea m, t he t u m or res p o nse of bi ntraf us p alfa i n c o m bi nati o n wit h 
c he m ot hera p y will be e val uate d b y I R C (I n de pe n de nt Re vie w C o m mittee). T he a nal ysis of 
c o nfir me d o bjecti ve res p o nse a n d P F S acc or di n g t o R E CI S T 1. 1 assesse d b y I R C will be 
perf or me d as descri be d i n Secti o n 1 4. 2. 1  a n d 1 4. 2. 3 . T he i m m u ne-relate d c o nfir me d o bjecti ve 
res p o nse a n d ir P F S acc or di n g t o ir R E CI S T 1. 1 assesse d b y I R C will als o be e val uate d.  
1 5  
S afet y A n al yses   
If n ot state d ot her wise, s u m maries will be prese nte d f or t he S A F A nal ysis S et b y c o h ort a n d 
c o m bi ne d 1 L C o h ort A, B, C.  
1 5. 1  
A d verse E ve nts   
Treat me nt e mer ge nt a d verse e ve nts ( T E A Es) a re t h ose e ve nts wit h o nset dates occ urri n g d uri n g 
t he o n-treat me nt peri o d ( o n-treat me nt peri o d defi ne d i n Secti o n  9) or if t he w orse ni n g of a n e ve nt 
is d uri n g t he o n-treat me nt peri o d. 
C ha n ges i n t o xicit y gra de, seri o us ness or o utc o me of A Es are rec or de d as se parate e ntries i n t he 
e C R F wit h ass ociate d e n d a n d start dates (start date e q uals e n d date of pre vi o us e ntr y). S uc h e ntries 
Gl o bal Versi o n I D: C CI


 
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re p orti n g t he sa me e ve nt i n s uc h i m me diatel y c o nsec uti ve peri o ds will be c o nsi dere d as o ne e ve nt 
i n t he a nal ysis. T hese e ve nts will be ke pt as se parate rec or ds i n t he data base i n or der t o mai ntai n 
t he f ull detaile d hist or y of t he e ve nts. T he start date of t he i nitial rec or d i n t he se q ue nce is ta ke n as 
start date of t he e ntire e ve nt, si milarl y t he e n d date of t he last e ve nt i n t he se q ue nce is ta ke n as e n d 
date of t he e ntire e ve nt. T he o verall o utc o me of t he a d verse e ve nt is t he o utc o me of t he last e ve nt 
i n t he se q ue nce. D urati o n of t he A E a n d t he T E A E fla g will be a dj uste d acc or di n gl y i n t he a nal ysis.  
All a nal yses descri be d i n t his secti o n will be base d o n T E A Es d uri n g o n -treat me nt peri o d if n ot 
ot her wise s pecifie d a n d will be descri be d b y c o h ort. T he A E listi n gs will i ncl u de all A Es ( w het her 
treat me nt-e mer ge nt or  n ot). A Es o utsi de t he o n -treat me nt peri o d will be fla g ge d i n t he listi n gs. 
A Es occ urri n g d uri n g t he rei nitiati o n p hase will be c o nsi dere d i n t he s u m mar y ta bles a n d will be 
fla g ge d i n t he listi n gs. 
I nc o m plete A E-relate d dates will be ha n dle d as state d i n Secti o n 9 . 
D ose Li miti n g T o xicities A d verse E ve nts  are t h ose e ve nts re p orte d o n t he “ A d verse E ve nt 
Details” e C R F pa ge wit h t he “Is t his a d verse e ve nt a d ose li miti n g t o xicit y” fiel d tic ke d “ Yes”.  
Bi ntr af us p alf a Rel ate d A d verse E ve nts  are t h ose A Es wit h relati o ns hi p t o bi ntraf us p alfa 
re p orte d b y t he In vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n “ Relati o ns hi p wit h M 7 8 2 4” = 
“ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge)  a n d t h ose of u n k n o w n relati o ns hi p (i.e., n o 
a ns wer t o t he q uesti o n “ Relati o ns hi p wit h M 7 8 2 4”) . 
C he m ot her a p y  Rel ate d A d verse E ve nts  are t h ose A Es wit h relati o ns hi p t o cis plati n or 
car b o plati n or pe metre xe d  or  paclita xel or  na b -paclita xel  or ge mcita bi ne  or d oceta xel  defi ne d as 
f oll o ws:  
•  F or cis plati n re p orte d b y t he In vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n 
“ Relati o ns hi p wit h Cis plati n ” = “ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge)  a n d 
t h ose of u n k n o w n relati o ns hi p (i.e., n o a ns wer t o t he q uesti o n “ Re lati o ns hi p wit h 
Cis plati n”).  
•  F or car b o plati n re p orte d b y t he In vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n 
“ Relati o ns hi p wit h Car b o plati n” = “ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge)  a n d 
t h ose of u n k n o w n relati o ns hi p (i.e., n o a ns wer t o t he q uesti o n “ Relati o ns hi p wit h 
Car b o plati n”) .  
•  F or pe metre xe d  re p orte d b y t he In vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n 
“ Relati o ns hi p wit h Pe metre xe d” = “ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge)  a n d 
t h ose of u n k n o w n relati o ns hi p (i.e., n o a ns wer t o t he q uesti o n “ Relati o ns hi p wit h 
Pe metre xe d”) .  
•  F or paclita xel re p orte d b y t he I n vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n 
“ Relati o ns hi p wit h Paclita xel” = “ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge) a n d 
t h ose of u n k n o w n relati o ns hi p (i.e., n o a ns wer t o t he q uesti o n “ Relati o ns hi p wit h 
Paclita xel”).  
•  F or na b -paclita xel  re p orte d b y t he In vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n 
“ Relati o ns hi p wit h Na b -paclita xel” = “ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge)  
Gl o bal Versi o n I D: C CI


 
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a n d t h ose of u n k n o w n relati o ns hi p (i.e. , n o a ns wer t o t he q uesti o n “ Relati o ns hi p wit h N ab -
paclita xel”) .  
•  F or ge mcita bi ne  re p orte d b y t he In vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n 
“ Relati o ns hi p wit h Ge mcita bi ne” = “ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge)  a n d 
t h ose of u n k n o w n relati o ns hi p (i.e., n o a ns wer t o t he q uesti o n “ Relati o ns hi p wit h 
Ge mcita bi ne”) .  
•  F or d oceta xel  re p orte d b y t he In vesti gat or as relate d (i.e. , a ns wer t o t he q uesti o n 
“ Relati o ns hi p wit h D oceta xel” = “ Relate d” o n “ A d verse E ve nt Details” e C R F pa ge)  a n d 
t h ose of u n k n o w n relati o ns hi p (i.e., n o a ns wer t o t he q uesti o n “ Relati o ns hi p wit h 
D oceta xel”) .  
Seri o us A d verse E ve nts ( S A Es) are t h ose e ve nts re p or te d o n t he “ A d verse E ve nt Details” e C R F 
pa ge wit h t he “ Seri o us A d verse E ve nt” fiel d tic ke d “ Yes”.  
A d verse E ve nts Le a di n g t o D ose Re d ucti o n  of C he m ot her a p y  A ge nt(s) : A Es lea di n g t o d ose 
re d ucti o n of cis plati n or car b o plati n  or pe metre xe d  or  paclita xel or  na b -paclita xel  or ge mcita bi ne  
or d oceta xel  are defi ne d as f oll o ws:    
•  F or cis plati n c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Cis plati n” = “ D ose 
re d uce d” o n “ A d verse E ve nt Details” e C R F pa ge).  
•  F or car b o plati n  c o nsi der  a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Car b o plati n” = 
“ D ose re d uce d” o n “ A d verse E ve nt Details” e C R F pa ge).  
•  F or pe metre xe d  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Pe metre xe d” = 
“ D ose re d uce d” o n “ A d verse E ve nt Details” e C R F pa ge).  
•  F or paclita xel c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Paclita xel” = “ D ose 
re d uce d” o n “ A d verse E ve nt Details” e C R F pa ge).  
•  F or na b -paclita xel  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Na b -paclita xel” 
= “ D ose re d uce d” o n “ A d verse E ve nt Details” e C R F pa ge).  
•  F or ge mcita bi ne  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Ge mcita bi ne” = 
“ D ose re d uce d” o n “ A d verse E ve nt Details” e C R F pa ge).  
•  F or d oceta xel  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h D oceta xel” = “ D ose 
re d uce d” o n “ A d verse E ve nt Details” e C R F pa ge).  
N ote t hat acc or di n g t o t he pr ot oc ol, t here will n ot be d ose re d ucti o n of bi ntraf us p alfa . 
A d verse E ve nts Le a di n g t o Te m p or ar y Disc o nti n u ati o n  of B i ntr af us p alf a: a ns wer t o t he 
q uesti o n “ Acti o n(s) ta ke n wit h M 7 8 2 4” = “ Dr u g i nterr u pte d”  o n “ A d verse E ve nt Details” e C R F 
pa ge.  
A d verse E ve nts Le a di n g t o Te m p or ar y Disc o nti n u ati o n of C he m ot her a p y: A Es lea di n g t o 
te m p orar y disc o nti n uati o n of cis plati n or car b o plati n  or pe metre xe d  or  paclita xel or  na b -paclita xel  
or ge mcita bi ne  or d oceta xel  are defi ne d as f oll o ws:  
•  F or cis plati n c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Cis plati n ” = “ Dr u g 
i nterr u pte d” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or car b o plati n  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Car b o plati n” = 
“ Dr u g i nterr u pte d” o n “ A d verse E ve nt Details” e C R F pa ge.  
Gl o bal Versi o n I D: C CI


 
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•  F or pe metre xe d  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Pe metre xe d ” = 
“ Dr u g i nterr u pte d” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or paclita xel c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Paclita xel” = “ Dr u g 
i nterr u pte d” o n “ A d verse E ve nt Details” e C R F pa ge. 
•  F or na b -paclita xel  c o nsi der a ns wer t o t he q uesti o n “ Act i o n(s) ta ke n wit h Na b-paclita xel” 
= “ Dr u g i nterr u pte d” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or ge mcita bi ne  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Ge mcita bi ne” = 
“ Dr u g i nterr u pte d” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or d oceta xel  c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h D oceta xel” = “ Dr u g 
i nterr u pte d” o n “ A d verse E ve nt Details” e C R F pa ge. 
A d verse E ve nts Le a di n g t o Te m p or ar y Disc o nti n u ati o n of at le ast o ne C he m ot her a p y: A Es 
lea di n g t o te m p orar y disc o nti n uati o n of cis plati n or car b o plati n or pe metre xe d  or  paclita xel or  na b -
paclita xel  or ge mcita bi ne  or d oceta xel  ( defi niti o n a b o ve). 
A d verse E ve nts Le a di n g t o Te m p or ar y Tre at me nt Disc o nti n u ati o n: A Es lea di n g t o te m p orar y 
disc o nti n uati o n of bi ntraf us p alfa ( defi niti o n a b o ve) or A Es lea di n g t o te m p orar y disc o nti n uati o n 
of at least o ne c he m ot hera p y  ( defi niti o n a b o ve). 
A d verse E ve nts Le a di n g t o Per m a ne nt Disc o nti n u ati o n of B i ntr af us p alf a: A Es lea di n g t o 
per ma ne nt disc o nti n uati o n of st u d y i nter ve nti o n (i.e., a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h 
M 7 8 2 4” = “ Dr u g wit h dra w n” o n “ A d verse E ve nt Details” e C R F pa ge).  
A d verse E ve nts Le a di n g t o Per m a ne nt Disc o nti n u ati o n of C he m ot her a p y : A Es lea di n g t o 
per ma ne nt disc o nti n uati o n of st u d y i nter ve nti o n f or cis plati n or car b o plati n or p e metre xe d or 
paclita xel or n a b-paclita xel or g e mcita bi ne or d oceta xel defi ne d as f oll o ws:  
•  F or cis plati n c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Cis plati n” = “ Dr u g 
wit h dra w n” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or car b oplati n c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Car b o plati n” = 
“ Dr u g wit h dra w n” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or p e metre xe d c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Pe metre xe d” = 
“ Dr u g wit h dra w n” o n “ A d verse E ve nt Details ” e C R F pa ge.  
•  F or paclita xel c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Paclita xel” = “ Dr u g 
wit h dra w n” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or n a b-paclita xel c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Na b -paclita xel” 
= “ Dr u g wit h dra w n” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or g e mcita bi ne c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h Ge mcita bi ne” = 
“ Dr u g wit h dra w n” o n “ A d verse E ve nt Details” e C R F pa ge.  
•  F or d oceta xel c o nsi der a ns wer t o t he q uesti o n “ Acti o n(s) ta ke n wit h D oceta x el” = “ Dr u g 
wit h dra w n” o n “ A d verse E ve nt Details” e C R F pa ge.  
A d verse E ve nts Le a di n g t o Per m a ne nt Disc o nti n u ati o n of at le ast o ne C he m ot her a p y: A Es 
lea di n g t o per ma ne nt disc o nti n uati o n of cis plati n or car b o plati n or p e metre xe d or paclita xel or 
n a b-paclita xel or g e mcita bi ne or d oceta xel ( defi niti o n a b o ve).  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
5 7 /8 5  
 
 
A d verse E ve nts Le a di n g t o Per m a ne nt Tre at me nt Disc o nti n u ati o n: A Es lea di n g t o per ma ne nt 
disc o nti n uati o n of bi ntraf us p alfa ( defi niti o n a b o ve) or A Es lea di n g t o per ma ne nt disc o nti nuati o n 
of at least o ne c he m ot hera p y  ( defi niti o n a b o ve). 
A d verse E ve nts Le a di n g t o Disc o nti n u ati o n / D ose Re d ucti o n of Tre at me nt: A Es lea di n g t o 
Te m p orar y Treat me nt Disc o nti n uati o n ( defi niti o n a b o ve) or A Es lea di n g t o Per ma ne nt Treat me nt 
Disc o nti n uati o n ( de fi niti o n a b o ve) or A Es lea di n g t o D ose Re d ucti o n of Treat me nt ( defi niti o n 
a b o ve). 
A d verse E ve nt Le a di n g t o De at h: A Es lea di n g t o deat h (as rec or de d o n t he “ A d verse E ve nt 
Details” e C R F pa ge, c ha n ge i n gra de = “ N o” a n d o utc o me = “ Fatal”, or gra de = “ Gra de  5 or deat h 
relate d t o A E” or seri o us a d verse e ve nt = “ Yes” a n d seri o us ness criteria i ncl u de “ Res ults i n 
deat h”).  
A d verse E ve nts of S peci al I nterest ( A E SI): A E SI will be i de ntifie d acc or di n g t o a pre -s pecifie d 
searc h list of Me d D R A Preferre d Ter ms.  
Cate g ori es of A E SIs c o nsi dere d i ncl u de : 
•  I nf usi o n-relate d reacti o n (I R R) 
•  I m m u ne-relate d a d verse e ve nts (ir A E) 
•  T G F -β i n hi biti o n me diate d s ki n A E  
•  A ne mia  
1 5. 1. 1   
All A d verse E ve nts   
A d verse e ve nts will be s u m marize d b y w orst se verit y (acc or di n g t o Nati o nal Ca ncer I nstit ute - 
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts [ N CI -C T C A E] versi o n 5. 0) per partici pa nt, 
usi n g Me d D R A (latest versi o n) preferre d ter m as e ve nt cate g or y a n d Me d D R A (latest versi o n) 
pri mar y s yste m or ga n class ( S O C) b o d y ter m as B o d y S yste m cate g or y.  
U nless ot her wise state d A Es will be dis pla ye d i n ter ms of fre q ue nc y ta bles: P T a n d pri mar y  S O C 
i n al p ha betical or der.  
If a n A E is re p orte d f or a gi ve n partici pa nt  m ore t ha n o nce d uri n g treat me nt, t he w orst se verit y 
a n d t he w orst relati o ns hi p t o st u d y i nter ve nti o n will be ta b ulate d. I n case a partici pa nt  ha d e ve nts 
wit h missi n g a n d n o n -missi n g gra des, t he ma xi m u m of t he n o n -missi n g gra des will be dis pla ye d.  
I nf or mati o n of s witc hers (s witc hes wit hi n c o h orts [fr o m o ne c he m ot hera p y t o a n ot her] a n d 
bet wee n c o h orts) will be i ncl u de d i n t he A E ta bles.   
A n  o verall s u m mar y ta ble of T E A Es will be prese nt e d wit h t he f oll o wi n g i nf or mati o n:  
•  T E A Es  
•  Bi ntraf us p alfa relate d T E A Es  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
5 8 /8 5  
 
 
•  C he m ot hera p y relate d T E A Es  
•  Cis plati n, or car b o plati n or pe metre xe d relate d T E A Es f or cis plati n or car b o plati n/ pe metre xe d 
c o m bi nati o n ( C o h ort  A)  
•  Cis plati n or pe metre xe d relate d T E A Es f or cis plati n/ pe metre xe d c o m bi nati o n (C o h ort  A)  
•  Car b o plati n or pe metre xe d relate d T E A Es f or car b o plati n/ pe metre xe d c o m bi nati o n (C o h ort  A)  
•  Car b o plati n or paclita xel or na b -paclita xel relate d T E A Es f or car b o plati n/ paclita xel or na b -
paclita xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or paclita xel relate d T E A Es f or car b o plati n/ paclita xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or na b -paclita xel relate d T E A Es f or car b o plati n/ na b -paclita xel c o m bi nati o n 
(C o h ort  B)  
•  Cis p lati n, or car b o plati n or ge mcita bi ne relate d T E A Es f or cis plati n or car b o plati n/ ge mcita bi ne 
c o m bi nati o n ( C o h ort  C)  
•  Cis plati n or ge mcita bi ne relate d T E A Es f or cis plati n/ ge mcita bi ne c o m bi nati o n  (C o h ort  C)  
•  Car b o plati n or ge mcita bi ne relate d T E A Es f or car b o plati n/ ge mcita bi ne c o m bi nati o n (C o h ort  
C)   
•  D oceta xel relate d T E A Es  (C o h ort  D)  
•  Seri o us T E A Es  
•  Bi ntraf us p alfa relate d seri o us T E A Es  
•  C he m ot hera p y relate d seri o us T E A Es  
•  Cis plati n, 
or car b o plati n 
or 
pe metre xe d relate d seri o us 
T E A Es f or cis plati n 
or 
car b o plati n/ pe metre xe d c o m bi nati o n ( C o h ort  A)  
•  Cis plati n or pe metre xe d relate d seri o us T E A Es f or cis plati n/ pe metre xe d c o m bi nati o n ( C o h ort  
A)  
•  Car b o plati n or pe metre xe d relate d seri o us T E A Es f or car b o plati n/ pe metre xe d c o m bi nati o n 
(C o h ort  A)  
•  Car b o plati n or pac lita xel or na b-paclita xel relate d seri o us T E A Es f or car b o plati n/ paclita xel or 
na b -paclita xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or paclita xel relate d seri o us T E A Es f or car b o plati n/ paclita xel c o m bi nati o n 
( C o h ort B) 
•  Car b o plati n 
or 
na b -paclita xel relate d seri o us 
T E A Es f or 
car b o plati n/ na b -paclita xel 
c o m bi nati o n ( C o h ort  B)  
•  Cis plati n, 
or car b o plati n 
or 
ge mcita bi ne relate d seri o us 
T E A Es f or cis plati n 
or 
car b o plati n/ ge mcita bi ne c o m bi nati o n ( C o h ort  C)  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
5 9 /8 5  
 
 
•  Cis plati n or ge mcita bi ne relate d seri o us T E A Es f or cis plati n/ ge mc ita bi ne c o m bi nati o n (C o h ort  
C)  
•  Car b o plati n or ge mcita bi ne relate d seri o us T E A Es f or car b o plati n/ ge mcita bi ne c o m bi nati o n 
(C o h ort  C)   
•  D oceta xel relate d seri o us T E A Es ( C o h ort  D)  
•  T E A Es N CI -C T C A E se verit y gra de ( 3, 4)  
•  Bi ntraf us p alfa relate d T E A Es N CI -C T C A E se verit y gra de ( 3, 4)  
•  C he m ot hera p y relate d T E A Es N CI -C T C A E se verit y gra de ( 3, 4)  
•  Cis plati n, or car b o plati n or pe metre xe d relate d T E A Es N CI -C T C A E se verit y gra de ( 3, 4) 
f or cis plati n or car b o plati n/ pe metre xe d c o m bi nati o n (C o h ort  A)  
•  Cis plati n or pe metre xe d relate d 
T E A Es 
N CI -C T C A E se verit y gra de ( 3, 4) f or 
cis plati n/ pe metre xe d c o m bi nati o n (C o h ort  A)  
•  Car b o plati n or pe metre xe d relate d T E A Es 
N CI -C T C A E se verit y gra de ( 3, 4) f or 
car b o plati n/ pe metre xe d c o m bi nati o n (C o h ort  A)  
•  Car b o plati n or paclita xel or na b -paclita xel relate d T E A Es N CI -C T C A E se verit y gra de ( 3, 4) 
f or car b o plati n/ paclita xel or na b-paclita xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or paclita xel relate d 
T E A Es 
N CI -C T C A E se verit y gra de ( 3, 4) f or 
car b o plati n/ paclit a xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or na b -paclita xel relate d T E A Es N CI -C T C A E se verit y gra de ( 3, 4) f or 
car b o plati n/ na b -paclita xel c o m bi nati o n (C o h ort  B)  
•  Cis plati n, or car b o plati n or ge mcita bi ne relate d T E A Es N CI -C T C A E se verit y gra de ( 3, 4) 
f or cis plati n or car b o plati n/ ge mcita bi ne c o m bi nati o n ( C o h ort  C)  
•  Cis plati n or ge mcita bi ne relate d 
T E A Es 
N CI -C T C A E se verit y gra de ( 3, 4) f or 
cis plati n/ ge mcita bi ne c o m bi nati o n (C o h ort  C)  
•  Car b o plati n or ge mcita bi ne relate d T E A Es 
N CI -C T C A E se verit y gra de ( 3, 4)  f or 
car b o plati n/ ge mcita bi ne c o m bi nati o n (C o h ort  C)   
•  D oceta xel relate d T E A Es N CI -C T C A E se verit y gra de ( 3, 4)  ( C o h ort  D)  
•  T E A Es lea di n g t o deat h  
•  Bi ntraf us p alfa relate d T E A Es lea di n g t o deat h 
•  C he m ot hera p y relate d T E A Es lea di n g t o deat h  
•  Cis plati n, or car b o plati n or pe metre xe d relate d T E A Es lea di n g t o deat h f or cis plati n or 
car b o plati n/ pe metre xe d c o m bi nati o n ( C o h ort  A)  
•  Cis plati n or pe metre xe d relate d T E A Es lea di n g t o deat h f or cis plati n/ pe metre xe d c o m bi nati o n 
(C o h ort  A)  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 0 /8 5  
 
 
•  Car b o plati n or pe metre xe d relate d T E A Es lea di n g t o deat h f or car b o plati n/ pe metre xe d 
c o m bi nati o n (C o h ort  A)  
•  Car b o plati n 
or 
paclita xel 
or 
na b -paclita xel relate d 
T E A Es lea di n g t o 
deat h f or 
car b o plati n/ paclita xel or na b -paclita xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or paclita xel relate d 
T E A Es lea di n g t o deat h f or car b o plati n/ paclita xel 
c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or na b -paclita xel relate d T E A Es lea di n g t o deat h f or car b o plati n/ na b -paclita xel 
c o m bi nati o n (C o h ort  B)  
•  Cis plati n, or car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o deat h f or cis plati n or 
car b o plati n/ ge mcita bi ne c o m bi nati o n ( C o h ort  C)  
•  Cis plati n or ge mcita bi ne relate d T E A Es lea di n g t o deat h f or cis plati n/ ge mcita bi ne c o m bi nati o n 
(C o h ort  C)  
•  Car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o deat h f or car b o plati n/ ge mcita bi ne 
co m bi nati o n (C o h ort  C)   
•  D oceta xel relate d T E A Es lea di n g t o deat h ( C o h ort  D)  
•  A d verse e ve nts of  s pecial i nterest (relate d a n d n ot relate d as assesse d b y i n vesti gat or):  
o  I nf usi o n-relate d reacti o n (I R R) 
o  I m m u ne relate d A Es (ir A Es) 
o  T G F -β  i n hi biti o nme diate d s ki n T E A Es  
o  A ne mia T E A Es  
•  Bi ntraf us p alfa relate d ad verse e ve nts of  s pecial i nterest (relati o ns hi p wit h bi ntraf us p alfa as 
assesse d b y i n vesti gat or) :  
o  I nf usi o n-relate d reacti o n (I R R) 
o  I m m u ne relate d A Es (ir A Es) 
o  T G F -β  i n hi biti o nme diate d s ki n T E A Es  
o  A ne mia T E A Es  
•  Treat me nt -e mer ge nt b lee di n g e ve nts 
•  Treat me nt -e mer ge nt b i ntraf us p alfa-relate d blee di n g e ve nts. 
Ta bles f or T E A Es fre q ue nc y c orres p o n di n g t o eac h cate g or y bel o w  will be pr o vi de d b y Me d D R A 
pri mar y S O C ( or dere d al p ha beticall y) a n d P T ( or dere d al p ha beticall y) . Eac h partici pa nt  will be 
c o u nte d o nl y o nce wit hi n eac h P T or S O C.  
•  T E A Es  
•  Bi ntraf us p alfa relate d T E A Es 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 1 /8 5  
 
 
•  C he m ot hera p y relate d T E A Es  (f or eac h c he m ot hera p y t o w hic h t he A E is relate d) 
•  T E A Es lea di n g t o deat h  (ta ble re peate d o n cis plati n vers us car b o plati n ( C o horts A a n d C))  
•  Bi ntraf us p alfa relate d T E A Es lea di n g t o deat h 
•  C he m ot hera p y relate d T E A Es lea di n g t o deat h (f or eac h c he m ot hera p y t o w hic h t he A E is 
relate d). 
T he f oll o wi n g fre q ue nc y ta bles will be pr o vi de d b y w orst gra de  ( > = 3, > = 4, 5), S O C, a n d P T: 
•  T E A Es b y w orst gra de, S O C, a n d P T  
•  Bi ntraf us p alfa relate d T E A Es b y w orst gra de, S O C, a n d P T  
•  C he m ot hera p y relate d T E A Es b y w orst gra de, S O C, a n d P T  (f or eac h c he m ot hera p y t o w hic h 
t he A E is relate d). 
Cli nic altri als. g o v a n d E u dr a C T -R e q uire me nts  
S u m mar y ta bl es f or n o n -seri o us T E A Es e xcl u di n g S A Es will be pr o vi de d. 
A listi n g of A Es will c o ntai n t he f oll o wi n g i nf or mati o n: c o h ort , partici pa nt  i de ntifier, a ge, se x, 
race, first a n d last date of st u d y i nter ve nti o n, preferre d ter m, re p orte d ter m f or t he A E, start or  
c ha n ge date, e n d date, d urati o n of A E (i n da ys), da y relati ve t o t he first st u d y i nter ve nti o n, da y 
relati ve t o t he m ost rece nt st u d y i nter ve nti o n pri or t o A E o nset /c ha n ge, relati o ns hi p wit h bi ntraf us p 
alfa, relati o ns hi p wit h cis plati n, relati o ns hi p wit h car b o plati n , relati o ns hi p wit h pe metre xe d , 
relati o ns hi p wit h paclita xel, relati o ns hi p wit h na b -paclita xel , relati o ns hi p wit h ge mcita bi ne , 
relati o ns hi p wit h d oceta xel , t o xicit y gra de, ca usalit y fact or, acti o n(s) ta ke n wit h bi ntraf us p alf a, 
acti o n(s) ta ke n wit h cis plati n , acti o n(s) ta ke n wit h car b o plati n, acti o n(s) ta ke n wit h pe metre xe d , 
acti o n(s) ta ke n 
wit h paclita xel, acti o n(s) ta ke n 
wit h na b -paclita xel , acti o n(s) ta ke n 
wit h 
ge mcita bi ne , acti o n(s) ta ke n wit h d oceta xel , ot her acti o n(s) take n, c ha n ge i n gra de a n d o utc o me, 
seri o us ness ( Y/ N), A E SI i nf usi o n-relate d ( Y/ N), A E SI i m m u ne-relate d ( Y/ N), T G F -β  i n hi biti o n 
me diate d s ki n A E SI ( Y/ N),  ane mia ( Y/ N) , d ose -li miti n g t o xicit y A E SI ( Y/ N). Partici pa nts w h o 
s witc he d c he m ot hera p y will be fla g ge d. T he listi n g will be s orte d b y c o h ort , partici pa nt  i de ntifier, 
start date, e n d date a n d preferre d ter m. 
F oll o wi n g listi n gs will be pr o vi de d wit h t he rele va nt i nf or mati o n:  
•  Listi n g of all A E ( w het her treat me nt -e mer ge nt or n ot) : T E A Es a n d A E occ urri n g d uri n g 
rei nitiati o n p hase will be fla g ge d 
•  Listi n g of T E A Es  
•  Listi n g of n o n -T E A E f or A Es occ urri n g after e nr oll me nt ( date of first si g nat ure of i nf or me d 
c o nse nt/ date of first si g nat ure of first i nf or me d c o nse nt) b ut pri or t o t he first d ose of st u d y  
i nter ve nti o n.   
•  Listi n g of A E wit h o nset or w orse ni n g after t he o n -treat me nt peri o d: A E occ urri n g d uri n g 
rei nitiati o n p hase will be fla g ge d 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 2 /8 5  
 
 
•  Listi n g of A Es f or partici pa nts w h o rei nitiate d t he treat me nt 
E v al u ati o n of P ote nti al Effect of A D A o n Bi ntr af us p a lf a S afet y  
T he o verall s u m mar y  ta ble of A Es as descri be d a b o ve will als o be pr o vi de d b y A D A stat us (e ver 
p ositi ve  vers us  ne ver p ositi ve , a n d treat me nt e mer ge nt A L L  vers us n o n treat me nt e mer ge nt A L L ). 
O nl y c o h orts wit h at least 3 partici pa nts i n eac h s u b gr o u p  will be dis pla ye d.  
A listi n g of all A Es (i ncl u di n g I R R) f or e ver -p ositi ve A D A partici pa nts ( pre -e xisti n g, tra nsie nt 
treat me nt-e mer ge nt, persiste nt  treat me nt-e mer ge nt) 
will be pre pare d i ncl u di n g partici pa nt 
i de ntifier a n d s h o wi n g t he date(s) of t he p ositi ve A D A res ult t o get her wit h t he A Es or I R Rs. F or 
t he A Es a n d I R Rs, start a n d st o p date will be s h o w n al o n g wit h gra de. A d verse e ve nts rec or de d 
d uri n g t he peri o d of 2  wee ks pri or t o t he p ositi ve A D A val ue till t w o wee ks after t he p ositi ve A D A 
val ue will be  fla g ge d. 
E v al u ati o n of C O VI D -1 9 effect o n A Es  
T he direct effect of C O VI D -1 9 f or A Es will be assesse d via listi n gs of C O VI D -1 9 relate d A Es.  
C O VI D -1 9 relate d A Es are all A Es f or w hic h t he P T c o ntai ns C O VI D -1 9 or S A R S -C O V -2 . T he 
f oll o wi n g i nf or mati o n will be pr o vi de d: 
•  Partici pa nt  I D, c o u ntr y, a ge, se x, race  
•  Date s of first  a n d last a d mi nistrati o n of eac h st u d y i nter ve nti o n  
•  C O VI D -1 9 -ass ociate d A E start date ( da y), C O VI D -1 9 ass ociate d A E st o p date ( da y)  
•  A E P T , ver bati m 
•  T o xicit y gra de  
•  Seri o us ne ss 
•  Relati o ns hi p t o eac h st u d y i nter ve nti o n  
•  Acti o n ta ke n  wit h eac h st u d y i nter ve nti o n  
•  O utc o me  
1 5. 1. 2   
A d verse  
E ve nts  
Le a di n g 
t o  
St u d y 
I nter ve nti o n 
Disc o nti n u ati o n   
A ta ble prese nti n g t he o verall s u m mar y of T E A Es lea di n g t o disc o nti n uati o n (te m p orar y or 
per ma ne nt) or d ose re d ucti o n of treat me nt will be prese nte d b y c o h ort  wit h t he f oll o wi n g  
i nf or mati o n:  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne  st u d y i nter ve nti o n 
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of bi ntraf us p alfa  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of c he m ot hera p y   
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 3 /8 5  
 
 
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne c he m ot hera p y  i n cis plati n or 
car b o plati n/ pe metre xe d c o m bi nati o n ( C o h ort  A)  
•  T E A Es lea di n g t o te m p orar y 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
cis plati n/pe metre xe d  c o m bi nati o n  (C o h ort  A)  
•  T E A Es lea di n g t o te m p orar y 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
car b o plati n/pe metre xe d  c o m bi nati o n (C o h ort  A)  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne c he m ot hera p y i n car b o plati n or 
paclita xel/ na b -paclita xel c o m bi nati o n ( C o h ort B)  
•  T E A Es lea di n g t o te m p orar y 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
car b o plati n/ paclita xel c o m bi nati o n ( C o h ort B)  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne c he m ot hera p y  i n car b o plati n/na b -
paclita xel  c o m bi nati o n  (C o h ort  B)  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne c he m ot hera p y  i n cis plati n or 
car b o plati n/ ge mcita bi ne c o m bi nati o n ( C o h ort  C)  
•  T E A Es lea di n g t o te m p orar y 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
cis plati n/ge mcita bi ne  c o m bi nati o n  (C o h ort  C)  
•  T E A Es lea d i n g t o te m p orar y 
disc o nti n uati o n 
of 
at least 
o ne c he m ot hera p y  i n 
car b o plati n/ge mcita bi ne c o m bi nati o n  (C o h ort  C)  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of d oceta xel  (C o h ort  D)   
•  Bi ntraf us p alfa relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of bi ntraf us p alfa  
•  C he m ot hera p y relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of c he m ot hera p y   
•  Cis plati n or car b o plati n or pe metre xe d relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of 
at least o ne  c he m ot hera p y  i n cis plati n or car b o plati n/ pe metre xe d c o m bi nati o n (C o h ort  A)  
•  Cis plati n or pe metre xe d relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n cis plati n/pe metre xe d  c o m bi nati o n  (C o h ort  A)  
•  Car b o plati n or pe metre xe d rel ate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n car b o plati n/pe metre xe d  c o m bi nati o n  (C o h ort  A)  
•  Car b o plati n or paclita xel or na b -paclita xel relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n 
of at least o ne c he m ot hera p y i n car b o plati n/ paclita xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or paclita xel relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n car b o plati n/ paclita xel c o m bi nati o n ( C o h ort B) 
•  Car b o plati n or na b -paclita xel relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least 
o ne c he m ot hera p y  i n car b o plati n/na b -paclita xel  c o m bi nati o n (C o h ort  B)  
•  Cis plati n or car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n 
of  at least o ne c he m ot hera p y  i n cis plati n or car b o plati n/ ge mcita bi ne c o m bi nati o n (C o h ort  C)  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 4 /8 5  
 
 
•  Cis plati n or ge mcita bi ne relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n cis plati n/ge mcita bi ne  c o m bi nati o n  (C o h ort  C)  
•  Car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n car b o plati n/ge mcita bi ne c o m bi nati o n  (C o h ort  C)  
•  D oceta xel relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of d oceta xel (C o h ort  D)  
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne st u d y i nter ve nti o n  
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of bi ntraf us p alfa  
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of c he m ot hera p y   
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne c he m ot hera p y  i n cis plati n or 
car b o plati n/ pe metre xe d c o m bi nati o n ( C o h ort  A)  
•  T E A Es lea di n g t o 
per ma ne nt 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
cis plati n/pe metre xe d  c o m bi nati o n  (C o h ort  A)  
•  T E A Es lea di n g t o 
per ma ne nt 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
car b o plati n/pe metre xe d  c o m bi nati o n (C o h ort  A)  
•  T E A Es lea di n g t o 
per ma ne nt 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y i n 
car b o plati n/ paclita xel or na b -paclita xel c o m bi nati o n ( C o h ort B)  
•  T E A Es lea di n g t o 
per ma ne nt 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y i n 
car b o plati n/ paclita xel c o m bi nati o n ( C o h ort B)  
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne c he m ot hera p y  i n car b o plati n/na b -
paclita xel  c o m bi nati o n  (C o h ort  B)  
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne c he m ot hera p y  i n cis plati n or 
car b o plati n/ ge mcita bi ne c o m bi nati o n ( C o h ort  C)  
•  T E A Es lea di n g t o 
per ma ne nt 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
cis plati n/ge mcita bi ne  c o m bi nati o n  (C o h ort  C)  
•  T E A Es lea di n g t o 
per ma ne nt 
disc o nti n uati o n 
of 
at least 
o ne 
c he m ot hera p y  i n 
carb o plati n /ge mcita bi ne c o m bi nati o n  (C o h ort  C)  
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of d oceta xel (C o h ort  D ) 
•  Bi ntraf us p alfa relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of bi ntraf us p alfa  
•  C he m ot hera p y relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of c he m ot hera p y   
•  Cis plati n or car b o plati n or pe metre xe d relate d T E A Es lea di n g t o per ma ne nt  disc o nti n uati o n of 
at least o ne c he m ot hera p y  i n cis plati n or car b o plati n/ pe metre xe d c o m bi nati o n (C o h o rt A)  
•  Cis plati n or pe metre xe d relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n cis plati n/pe metre xe d  c o m bi nati o n  (C o h ort  A)  
•  Car b o plati n or pe metre xe d relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n car b o plati n/pe metre xe d  c o m bi nati o n  (C o h ort  A)  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 5 /8 5  
 
 
•  Car b o plati n 
or 
paclita xel 
or 
na b -paclita xel relate d 
T E A Es lea di n g t o 
per ma ne nt 
disc o nti n uati o n of at least o ne c he m ot hera p y i n car b o plati n/ paclita xel or na b -paclita xel 
c o m bi nati o n ( C o h ort B)  
•  Car b o plat i n or paclita xel relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n car b o plati n/ paclita xel c o m bi nati o n ( C o h ort B) 
•  Car b o plati n or na b -paclita xel relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least 
o ne c he m ot hera p y  i n car b o plati n/na b -paclita xel  c o m bi nati o n (C o h ort  B)  
•  Cis plati n or car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n 
of at least o ne c he m ot hera p y  i n cis plati n or car b o plati n/ ge mcita bi ne c o m bi nati o n (C o h ort  C)  
•  Cis plati n or ge mcita bi ne relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne 
c he m ot hera p y i n cis plati n/ge mcita bi ne  c o m bi nati o n  (C o h ort  C)  
•  Car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of at least o ne 
c he m ot hera p y  i n car b o plati n/ge mcita bi ne c o m bi nati o n  (C o h ort  C)  
•  D oceta xel relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of d oceta xel (C o h ort  D)  
•  T E A Es lea di n g t o d ose re d ucti o n of a t least o ne c he m ot hera p y   
•  T E A Es lea di n g t o d ose re d ucti o n of at least o ne 
c he m ot hera p y  i n cis plati n or 
car b o plati n/ pe metre xe d c o m bi nati o n ( C o h ort  A)  
•  T E A Es lea di n g t o d ose re d uc ti o n of at least o ne c he m ot hera p y i n cis plati n/pe metre xe d  
c o m bi nati o n (C o h ort  A)  
•  T E A Es lea di n g t o d ose re d ucti o n of at least o ne c he m ot hera p y  i n car b o plati n/pe metre xe d  
c o m bi nati o n (C o h ort  A)  
•  T E A Es lea di n g t o d ose re d ucti o n of  at least o ne c he m ot hera p y i n car b o plati n/ paclita xel or na b -
paclita xel c o m bi nati o n ( C o h ort B)  
•  T E A Es lea di n g t o d ose re d ucti o n of at least o ne c he m ot hera p y  i n car b o plati n/ paclita xel 
c o m bi nati o n ( C o h ort B)  
•  T E A Es lea di n g t o d ose re d ucti o n of at least o ne c he mot hera p y  i n car b o plati n/na b -paclita xel  
c o m bi nati o n (C o h ort  B)  
•  T E A Es lea di n g t o d ose re d ucti o n of at least o ne 
c he m ot hera p y  i n cis plati n or 
car b o plati n/ ge mcita bi ne c o m bi nati o n ( C o h ort  C)  
•  T E A Es lea di n g t o d ose re d ucti o n of at least o ne c he m ot hera p y  i n cis plati n/ge mcita bi ne  
c o m bi nati o n (C o h ort  C)  
•  T E A Es lea di n g t o d ose re d ucti o n of at least o ne c he m ot hera p y  i n car b o plati n/ ge mcita bi ne 
c o m bi nati o n (C o h ort  C)  
•  T E A Es lea di n g t o d ose re d ucti o n of d oceta xel  (C o h ort  D) . 
•  C he m ot hera p y relate d T E A Es lea di n g t o d ose re d ucti o n of c he m ot hera p y  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 6 /8 5  
 
 
•  Cis plati n or car b o plati n or pe metre xe d relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne 
c he m ot hera p y  i n cis plati n or car b o plati n/ pe metre xe d c o m bi nati o n (C o h ort  A)  
•  Cis plati n or pe metre xe d relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne c he m ot hera p y  
i n cis plati n/pe metre xe d  c o m bi nati o n (C o h ort  A)  
•  Car b o plati n or pe metre xe d relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne 
c he m ot hera p y  i n car b o plati n/pe metre xe d  c o m bi nati o n  (C o h ort  A)  
•  Car b o plati n or p aclita xel or na b -paclita xel relate d T E A Es lea di n g t o d ose re d ucti o n of at least 
o ne c he m ot hera p y i n car b o plati n/ paclita xel or na b -paclita xel c o m bi nati o n ( C o h ort B)  
•  Car b o plati n or paclita xel relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne c he m ot hera p y  
i n car b o plati n/ paclita xel c o m bi nati o n ( C o h ort B) 
•  Car b o plati n or na b -paclita xel relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne 
c he m ot hera p y  i n car b o plati n/na b -paclita xel  c o m bi nati o n (C o h ort  B)  
•  Cis plati n or car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne 
c he m ot hera p y  i n cis plati n or car b o plati n/ ge mcita bi ne c o m bi nati o n (C o h ort  C)  
•  Cis plati n or ge mcita bi ne relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne c hem ot hera p y  
i n cis plati n/ge mcita bi ne  c o m bi nati o n  (C o h ort  C)  
•  Car b o plati n or ge mcita bi ne relate d T E A Es lea di n g t o d ose re d ucti o n of at least o ne 
c he m ot hera p y  i n car b o plati n/ge mcita bi ne c o m bi nati o n  (C o h ort  C)  
•  D oceta xel relate d T E A Es lea di n g t o d ose re d ucti o n of  d oceta xel  (C o h ort  D) . 
Fre q ue nc y ta bles s u m marizi n g t he f oll o wi n g acti o ns ta ke n i n res p o nse t o T E A Es will be pre pare d 
a n d prese nte d b y P T a n d pri mar y S O C i n al p ha betical or der:  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of bi ntraf us p alfa  
•  T E A Es lea di n g t o te m p orar y disc o nti n uati o n of c he m ot hera p y (f or eac h c he m ot hera p y f or 
w hic h t he A E le d t o te m p orar y disc o nti n uati o n) 
•  Bi ntraf us p alfa relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of bi ntraf us p alfa  
•  C he m ot hera p y relate d T E A Es lea di n g t o te m p orar y disc o nti n uati o n of c he m ot hera p y (f or eac h 
c he m ot hera p y t o w hic h t he A E is relate d, a n d f or w hic h t he A E le d t o te m p orar y 
disc o nti n uati o n ) 
•  T E A Es lea di n g t o p er ma ne nt d isc o nti n uati o n of bi ntraf us p alfa  (ta ble re peate d o n cis plati n 
vers us car b o plati n ( C o h orts A a n d C))  
•  T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of c he m ot hera p y (f or eac h c he m ot hera p y f or 
w hic h t he A E le d t o per ma ne nt disc o nti n ua ti o n) 
•  Bi ntraf us p alfa relate d T E A Es lea di n g t o p er ma ne nt d isc o nti n uati o n of bi ntraf us p alfa  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
6 7 /8 5  
 
 
•  C he m ot hera p y relate d T E A Es lea di n g t o per ma ne nt disc o nti n uati o n of c he m ot hera p y (f or eac h 
c he m ot hera p y t o w hic h t he A E is relate d, a n d f or w hic h t he A E le d t o per ma ne nt 
disc o nti n uati o n ). 
A  listi n g of A Es lea di n g t o per ma ne nt treat me nt disc o nti n uati o n will als o be pr o vi de d wit h t he 
rele va nt i nf or mati o n (see descri pti o n of listi n g i n Secti o n 1 5. 1. 1 ). A listi n g of  c he m ot hera p y 
s witc hers ma y als o be pr o vi de d. 
1 5. 2  
De at hs, Ot her Seri o us A d verse E ve nts, a n d Ot her Si g nific a nt 
A d verse E ve nts   
1 5. 2. 1   
De at hs   
All deat hs, deat hs wit hi n 3 0 da ys after last d ose of st u d y i nter ve nti o n, deat hs wit hi n 6 0 da ys after 
first d ose as well as pri mar y reas o n f or deat h, will be ta b ulate d base d o n inf or mati o n fr o m t he 
“ Deat h” e C R F pa ge.  
T he f oll o wi n g s u m maries will be pr o vi de d b y c o h ort  a n d b y cis plati n vers us car b o plati n ( C o h orts 
A a n d C) : 
•  N u m ber of deat hs  
•  N u m ber of deat hs wit hi n 3 0 da ys after last d ose of st u d y i nter ve nti o n 
•  N u m ber of deat hs wit hi n 6 0 da ys after first d ose of st u d y i nter ve nti o n 
•  Pri mar y reas o n of deat h  
o  Pr o gressi o n of disease a n d/ or disease relate d c o n diti o n  
o  E ve nt u nrelate d t o st u d y treat me nt  
o  E ve nt relate d t o st u d y treat me nt  
o  U n k n o w n  
I n a d diti o n, date a n d ca use of deat h will be pr o vi de d i n a n i n di vi d ual partici pa nt  data listi n g 
t o get her wit h selecte d d osi n g i nf or mati o n ( date of first/last a d mi nistrati o n of bi ntraf us p alfa , 
n u m ber of i nf usi o ns of bi ntraf us p alfa , da y relati ve t o first an d last i nf usi o n of bi ntraf us p alfa , date 
of first/last a d mi nistrati o n of cis plati n, n u m ber of i nf usi o ns of cis plati n, da y relati ve t o first a n d 
last i nf usi o n of cis plati n, date of first/last a d mi nistrati o n of car b o plati n , n u m ber of i nf usi o ns of 
car b o plati n , da y relati ve t o first a n d last i nf usi o n of car b o plati n , date of first/last a d mi nistrati o n of 
pe metre xe d , n u m ber of i nf usi o ns of pe metre xe d , da y relati ve t o first a n d last i nf usi o n of 
pe metre xe d , date of first/last a d mi nistrati o n of paclita xel, n u m ber of i nf usi o ns of paclita xel, da y 
relati ve t o first a n d last i nf usi o n of paclita xel, date of first/last a d mi nistrati o n of na b -paclita xel , 
n u m ber of i nf usi o ns of na b -paclita xel , da y relati ve t o first a n d last i nf usi o n of na b -p aclita xel , date 
of first/last a d mi nistrati o n of ge mcita bi ne , n u m ber of i nf usi o ns of ge mcita bi ne , da y relati ve t o first 
a n d last i nf usi o n of ge mcita bi ne , date of first/last a d mi nistrati o n of d oceta xel , n u m ber of i nf usi o ns 
of d oceta xel , da y relati ve t o first a n d last i nf usi o n of d oceta xel ) a n d will i ncl u de:  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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•  Partici pa nt i de ntifier, a nal ysis set, a ge, se x, race  
•  A Es wit h fatal o utc o me (list preferre d ter ms of A Es wit h o utc o me =fatal, Gra de 5 or Seri o us 
res ulti n g i n deat h) 
•  A ut o ps y perf or me d ( Yes/ N o/ U n k n o w n)  
•  Fla g f or deat h wit hi n 3 0 da ys after last st u d y i nter ve nti o n 
•  Fla g f or deat h wit hi n 6 0 da ys after first st u d y i nter ve nti o n. 
1 5. 2. 2   
Seri o us A d verse E ve nts   
T he n u m ber of partici pa nt s wit h seri o us A Es ( S A Es) will be descri be d b y S O C a n d P T:  
•  Seri o us T E A Es  (ta ble re peate d o n cis plati n vers us car b o plati n ( C o h orts A a n d C)) 
•  Bi ntraf us p alfa relate d seri o us T E A Es  
•  C he m ot hera p y relate d seri o us T E A Es (f or eac h c he m ot hera p y t o w hic h t he A E is relate d). 
A listi n g of seri o us T E A Es will als o be pr o vi de d wit h t he rele va nt i nf or mati o n  (see descri pti o n of 
listi n g i n Secti o n 1 5. 1. 1 ). 
1 5. 2. 3   
D ose -Li miti n g T o xicit y   
T he c o m bi nati o n will be c o nsi dere d safe w he n D L Ts (as s pecifie d i n pr ot oc ol secti o n 6. 9. 1) are 
o bser ve d i n ≤ 2 of t he 8 e val ua ble partici pa nts. If D L Ts are o bser ve d i n ≥ 3 of t he 8 partici pa nts, 
t he S M C will gi ve a rec o m me n dati o n re gar di n g cleari n g t he c orres p o n di n g c o m bi nati o n base d o n 
a re vie w of all rele va nt para meters i ncl u di n g A Es a n d S A Es a n d ris k be nefit assess me nt f or t hat 
c o h ort. 
A ta ble of t he occ urre nce of D L T ad verse eve nts (as defi ne d i n Secti o n 1 5. 1 ) will be pr o vi de d 
i ncl u di n g: 
•  N u m ber a n d perce nta ge of partici pa nts w h o e x perie nce d a D L T d uri n g t he D L T peri o d  ( 3 
wee ks fr o m t he W 1 D 1 visit)  
•  N u m ber of D L Ts per partici pa nt e x perie nce d d uri n g t he D L T peri o d ( 1 / 2 / ≥3)  
•  D L T e x perie nce d d uri n g t he D L T peri o d b y S yste m Or ga n Class a n d Preferre d Ter m base d 
o n t he latest a vaila ble Me d D R A versi o n.  
A listi n g of D L Ts will als o be pr o vi de d wit h t he rele va nt i nf or mati o n  (see descri pti o n of listi n g i n 
Secti o n 1 5. 1. 1 ).  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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1 5. 2. 4   
Blee di n g E ve nts   
Blee di n g e ve nts are defi ne d as a d verse e ve nts wit h Preferre d Ter ms ( P Ts ) acc or di n g t o t he 
Me d D R A S M Q Hae m orr ha ge ter ms (e xcl u di n g  la b orat or y ter ms). Treat me nt -e mer ge nt b lee di n g 
e ve nts a n d treat me nt-e mer ge nt bi ntraf us p alfa relate d blee di n g e ve nts will be s u m marize d i n a 
fre q ue nc y ta ble prese nti n g S O C a n d P T s orte d b y al p ha betical or der, b y c o h ort ( C o h ort A, B, C, 
a n d D)  a n d c o m bi ni n g C o h ort s A, B, a n d C ( 1 L C o h ort A, B, C) a n d re peate d b y cis plati n vers us 
car b o plati n f or C o h orts A a n d C.  T he w orst gra de per partici pa nt, per S O C a n d per P T will be 
re p orte d ( A n y g ra de [i ncl u di n g missi n g gra de], Gra de ≥ 3, Gra de ≥ 4, a n d Gra de 5).  
1 5. 2. 5   
A d verse E ve nts of S peci al I nterest   
1 5. 2. 5. 1   
I nf usi o n-R el ate d  
R e acti o ns  
Incl u di n g  
Im me di ate 
H y perse nsiti vit y   
I nf usi o n-relate d reacti o ns (I R R) are defi ne d as a d verse e ve nts wit h P Ts o n a pre-s pecifie d list of 
Me d D R A P Ts  a n d di vi de d i nt o reacti o ns vers us si g ns a n d s y m pt o ms.  
Re acti o ns of I R R: s h o ul d be c o nsi dere d w he n o nset is o n t he da y of bi ntraf us p alfa a n d/ or 
c he m ot hera p y i nf usi o n ( d uri n g or after t he i nf usi o n) or t he da y after t he i nf usi o n (irres pecti ve of 
res ol uti o n date) f or a n y i nf usi o n-relate d reacti o n, dr u g h y perse nsiti vit y, a na ph ylactic reacti o n, 
h y perse nsiti vit y a n d/ or T y pe  1 h y perse nsiti vit y.  
Si g ns a n d s y m pt o ms of I R Rs a n d h y perse nsiti vit y/ aller gic re acti o ns:  s h o ul d be c o nsi dere d 
w he n o nset is o n t he da y of bi ntraf us p alfa a n d/ or c he m ot hera p y i nf usi o n ( d uri n g or after t he 
i nf usi o n) a n d res ol ve d c o m pletel y wit h t he e n d date o n t he sa me da y of t he i nf usi o n or t he da y 
after.  
T he fre q ue nc y ta ble of I R R A Es b y w orst gra de, S O C, a n d P T will be pr o vi de d  a n d re peate d o n 
cis plati n vers us car b o plati n ( C o h orts A a n d C) . 
T he listi n g of I R Rs will als o be pr o vi de d wit h t he rele va nt i nf or mati o n (see descri pti o n of listi n g 
i n Secti o n 1 5. 1. 1 ). 
1 5. 2. 5. 2   
I m m u ne-R el ate d A Es   
I m m u ne-relate d a d verse e ve nts (ir A Es) will be i de ntifie d pr o gra m maticall y. A Es w hic h satisf y all 
of t he f oll o wi n g criteria will be fla g ge d as i m m u ne -relate d: 
1)  T he A E preferre d ter m matc hes a  preferre d ter m o n t he list of pre -selecte d Me d D R A ter ms. 
2)  T he A E  o nset or w orse ni n g occ urs d uri n g t he o n -treat me nt peri o d f or ir A Es (see Secti o n 
9. 8 ). 
3)  O n t he “ A E” e C R F pa ge, t he q uesti o n “ Were C ortic oster oi ds,  I m m u n os u p presa nts, or 
h or m o nal t hera p y (e. g. , T h yr oi d) a p plie d?” has t he a ns wer “ Yes” selecte d.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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4)  O n t he “i m A E S pecific Q uesti o ns ” e C R F pa ge, eit her:  
a.  T he q uesti o n “ D oes a n y of t he f oll o wi n g pr o vi de a clear eti ol o g y f or t he e ve nt?” has t he 
a ns wer “ N o” selecte d, i n dicati n g t hat t he A E is n ot attri b uta ble t o u n derl yi n g ca ncer 
disease/ P D, pri or or c o nc o mita nt me dicati o ns/ pr oce d ures, n or a n ot her me dical c o n diti o n 
s uc h as a n i nfecti o n or pre-e xisti n g disease.  
O R  
b.    T he “i m A E S pecific Q uesti o ns ” e C R F pa ge i n dicates t hat a bi o ps y was perf or me d a n d t he 
q uesti o n “Is t he hist o pat h ol o g y/ bi o ps y c o nsiste nt wit h a n i m m u ne -me diate d e ve nt?” has 
t he a ns wer “ Yes” selecte d. 
I n t he case t hat criteria ( 1) t hr o u g h ( 3) are met, a n d e ntries f or c o n diti o n ( 4) are missi n g, t he 
f oll o wi n g r ules will be a p plie d:  
•   If t he a ns wer t o “ D oes a n y of t he f oll o wi n g pr o vi de a clear eti ol o g y f or t he e ve nt?” ( 4a) 
is missi n g, t he e ve nt will be c o nsi dere d as ir A E (irres pecti ve of bi o ps y res ults).  
•   If t he a ns wer t o “Is t he hist o pat h ol o g y/ bi o ps y c o nsiste nt wit h a n i m m u ne -me diate d 
e ve nt?” ( 4 b) is missi n g, or if n o bi o ps y was perf or me d, a n d c o n diti o n ( 4a) is n ot satisfie d 
(i.e., “ Yes” is selecte d as t he a ns wer t o t he q uesti o n “ D oes a n y of t he f oll o wi n g pr o vi de 
a clear eti ol o g y f or t he e ve nt?”), t he e ve nt will be c o nsi dere d as a n o n-ir A E. 
P Ts will be c o m pile d i nt o cate g ories: I m m u ne -me diate d ras h, I m m u ne -me diate d c olitis, I m m u ne -
me diate d p ne u m o nitis, I m m u ne -me diate d he patitis, I m m u ne -me diate d ne p hritis a n d re nal 
d ysf u ncti o n, I m m u ne -me diate d e n d ocri n o pat hies ( A dre nal i ns ufficie nc y,  H y p o g o na dis m, 
Pit uitar y d ysf u ncti o n, T y pe 1 Dia betes Mellit us , T h yr oi d dis or ders), Ot her i m m u ne-me diate d 
m y ositis, Ot her i m m u ne -me diate d a d verse e ve nts.  
T he fre q ue nc y ta ble of ir A Es b y w orst gra de, cate gories , a n d P T will be pr o vi de d a n d re peate d o n 
cis plati n vers us car b o plati n ( C o h orts A a n d C) . 
T he listi n g of ir A Es will als o be pr o vi de d wit h t he rele va nt i nf or mati o n (see descri pti o n of listi n g 
i n Secti o n  1 5. 1. 1). 
1 5. 2. 5. 3   
T G F -β I n hi biti o n Me di ate d S ki n T E A Es   
T G F -β i n hi biti o n me diate d ski n A Es will be selecte d base d o n Me d D R A P Ts acc or di n g t o a pre -
s pecifie d Me d D R A searc h list:  
N arr o w defi niti o n:  
•  Kerat oaca nt h o ma  ( K A) 
•  S q ua m o us cell carci n o ma of s ki n  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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Br o a d defi niti o n  has a d diti o nal P Ts:  
•  H y per kerat osis  
•  Acti nic kerat osis  
•  Basal cell carci n o ma  
•  Li p s q ua m o us cell carci n o ma  
•  B o we n’s disease  
N ote t hat t he list a b o ve ma y n ot be c o m pre he nsi ve as it u n der g oes sc he d ule d re vie ws f or u p dates.  
A ta ble f or  T G F -β i n hi biti o n me diate d s ki n T E A Es fre q ue nc y will be pr o vi de d b y Me d D R A P Ts 
(i ncl u di n g b ot h narr o w a n d br oa d defi niti o n P Ts) a n d re peate d  o n cis plati n vers us car b o plati n 
( C o h orts A a n d C). A ta b ulati o n of P Ts b y w orst gra de (a n y gra de, ≥ 3, ≥ 4, 5) will als o be pr o vi de d.  
A listi n g of  T G F -β i n hi biti o n me diate d s ki n A Es will als o be pr o vi de d wit h t he rele va nt 
i nf or mati o n (see descri pti o n of listi n g i n Secti o n 1 5. 1. 1 ), pl us t he n u m ber of lesi o ns, lesi o n l ocati o n 
a n d dia g n osis c o nfir me d b y bi o ps y/e xcisi o n ( Y/ N) . 
1 5. 2. 5. 4   
A ne mi a   
T o i de ntif y p ote ntial a ne mia A Es, Me d D R A P T q ueries will be use d t o searc h f or a ne mia A Es of 
i nterest i n t he cli nical data base. F urt her details (e. g., Me d D R A P T q ueries) are re g ularl y u p date d 
base d o n t he c urre nt Me d D R A versi o n.  
•  A nae mias N E C ( H L T)  
•  A nae mias hae m ol ytic i m m u ne ( H L T)  
•  A nae mias hae m ol ytic N E C ( H L T)  
•  Hae m o gl o bi n decrease d ( P T)  
T he fre q ue nc y ta ble of p ote ntial treat me nt-e mer ge nt a ne mia b y w orst gra de, S O C, a n d P T will be 
pr o vi de d.  
A listi n g of all a ne mia T E A Es will be pr o vi de d wit h t he rele va nt i nf or mati o n (see descri pti o n of 
listi n g i n Secti o n 1 5. 1. 1 ). Bi ntraf us p alfa  relate d a ne mia will be fla g ge d. 
1 5. 3  
Cli nic al L a b or at or y E v al u ati o n   
O n -treat me nt la b orat or y val ues (i ncl u di n g c orres p o n di n g n or mal ra n ges) c o n verte d i n sta n dar d 
u nits will be use d f or s u m mar y statistics a n d s hift ta bles  ( o n-treat me nt peri o d defi ne d i n Secti o n 
9 ). 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
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La b orat or y res ults will be classifie d acc or di n g t o t he N CI -C T C A E Versi o n 5. 0  a n d as s pecifie d i n 
A p pe n di x 3 . A d diti o nal la b orat or y res ults t hat are n ot part of N CI-C T C A E will be prese nte d 
acc or di n g t o t he cate g ories: l o w, n or mal a n d hi g h (acc or di n g t o t he la b orat or y n or mal ra n ges).  
Q ua ntitati ve data will be e xa mi ne d f or tre n ds usi n g descri pti ve statistics ( mea n, St D , M e dia n, Q 1, 
Q 3, M i n, a n d M a x) of act ual baseli ne val ues, o n -treat me nt val ues a n d c ha n ges fr o m baseli ne t o 
eac h o n -treat me nt visit o ver ti me. T he c ha n ges c o m p ute d will be t he differe nces fr o m baseli ne. 
Q ualitati ve data base d o n refere nce ra n ges will be descri be d acc or di n g t o t he ca te g ories (i.e., l o w, 
n or mal, a n d hi g h).  
S u m mar y ta bles o ver ti me will prese nt s u m mar y statistics f or c o nti n u o us a n d cate g orical varia bles 
b y ti me p oi nt, b y c o h ort  a n d c o m bi ni n g C o h ort s A, B, a n d C ( 1 L C o h ort A, B, C).  
T he f oll o wi n g fi g ures will als o be pr o vi de d b y c o h ort : 
•  B o x pl ots of t he la b orat or y val ues b y ti me p oi nt  
•  B o x pl ots of t he c ha n ge fr o m baseli ne b y ti me p oi nt  
B o x pl ots f or la b orat or y para meters w here t o xicit y gra des are defi ne d base d o n t he rati o of t he 
para meter val ues a n d t he u p per li mit of n or mal ( U L N) will n ot be dis pla ye d usi n g t he u nit of 
meas ure me nt b ut i nstea d usi n g t he rati o of t he meas ure d val ue o ver U L N. T his c o m prises al kali ne 
p h os p hatase ( A L P), ala ni ne a mi n otra nsferase ( A L T), as partate a mi n otra nsferase ( A S T), bilir u bi n, 
creati ni ne , 
a m ylase a n d 
acti vate d 
partial t hr o m b o plasti n ti me. 
Val ues > 5 0 * U L N 
a n d 
val ues < L L N/ 5 0 ma y be re m o ve d fr o m b o x pl ots if nee de d f or t he rea da bilit y of t he fi g ure ( wit h a 
f o ot n ote a d de d pr o vi di n g t he n u m ber of partici pa nts re m o ve d fr o m t he fi g ure). 
L a b or at or y P ar a meters wit h N CI -C T C G r a des A v ail a ble  
La b orat or y para meters wit h N CI -C T C gra des a vaila ble will be a nal yze d wit h t heir res pecti ve N CI -
C T C na me a n d directi o n of a b n or malit y. F or para meters w hic h are gra de d wit h b ot h l o w a n d hi g h 
val ues, t he t o x icities will be s u m marize d se paratel y. L o w directi o n t o xicit y gra des at B aseli ne a n d 
p ost -baseli ne will be set t o 0 w he n t he varia bles are deri ve d f or s u m marizi n g hi g h directi o n 
t o xicit y, a n d vice versa.  
F or gra da ble para meters, t he f oll o wi n g s u m maries wi ll be dis pla ye d b y c o h ort a n d c o m bi ni n g 
C o h ort s A, B, a n d C ( 1 L C o h ort A, B, C): 
•  N u m ber a n d perce nta ge of partici pa nt s b y w orst o n-treat me nt gra de ( > = 1, > = 3, > = 4) 
•  S hift i n t o xicit y gra di n g fr o m baseli ne t o hi g hest  o n -treat me nt gra de . 
T he defi niti o ns of t he N CI -C T C A E t o xicit y gra di n g versi o n 5. 0 f or eac h para meter are pr o vi de d 
i n A p pe n di x  3  of t his IA P .  
F or W B C differe ntial c o u nts ( ne utr o p hil, l y m p h oc yte c o u nts), t he a bs ol ute val ue will be use d w he n 
re p orte d.  
W he n o nl y perce nta ges are a vaila ble (t his is mai nl y i m p orta nt f or ne utr o p hils a n d 
Gl o bal Versi o n I D: C CI


 
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I N F O R M A T I O N 
7 3 /8 5  
 
 
l y m p h oc ytes, beca use t he C T C A E gra di n g is base d o n t he a bs ol ute c o u nts), t he a bs ol ute val ue is 
deri ve d as f oll o ws:  
Deri ve d differe ntial a bs ol ute c o u nt = ( W B C c o u nt) * ( Differe ntial % val ue / 1 0 0)  
F or calci u m, C T C A E gra di n g is base d o n C orrecte d Calci u m a n d I o nize d Calci u m ( C A L CI O), if 
a vaila ble. C orrecte d Calci u m is calc ulate d fr o m Al b u mi n a n d Calci u m as f oll o ws:  
o   
C orrecte d Calci u m ( m g/ d L) = Calci u m ( m g/ d L) –  0. 8 [ Al b u mi n ( g/ d L) -4] , or 
o   
C orrecte d calci u m ( m m ol/ L) = meas ure d t otal calci u m ( m m ol/ L) + 0. 0 2 ( 4 0 –  
ser u m al b u mi n [ g/ L]) 
L a b or at or y P ar a meters wit h N CI -C T C G r a des n ot A v ail a ble  
F or all n o n -gra da ble para meters, t he f oll o wi n g s u m maries will be dis pla ye d b y c o h ort a n d 
c o m bi ni n g C o h ort s A, B, a n d C ( 1 L C o h ort A, B, C): 
•  S hift fr o m baseli ne t o l o west o n -treat me nt val ue (classifie d as n or mal, hi g h, l o w) 
•  S hift fr o m baseli ne t o t he hi g hest o n -treat me nt val ue (classifie d as n or mal, hi g h, l o w) 
•  N u m ber a n d perce nta ge  of partici pa nts  b y w or st o n-treat me nt val ue (classifie d as n or mal, hi g h, 
l o w) 
Li ver F u ncti o n T ests 
T he n u m ber a n d perce nta ge of partici pa nt s wit hi n eac h of t he f oll o wi n g li ver f u ncti o n cate g ories 
d uri n g o n -treat me nt peri o d will be descri be d per c o h ort a n d c o m bi ni n g C o h ort s A, B, a n d C ( 1 L 
C o h ort A, B, C) : 
•  A L T < 3 × U L N, A L T ≥ 3 × U L N, A L T ≥ 5 × U L N, A L T ≥ 1 0 × U L N, A L T ≥ 2 0 × U L N  
•  A S T < 3 × U L N, A S T ≥ 3 × U L N, A S T ≥ 5 x U L N, A S T ≥ 1 0 × U L N, A S T ≥ 2 0 × U L N  
•  ( A L T a n d A S T) < 3 × U L N, ( A L T or A S T) ≥ 3 × U L N, ( A L T or A S T)  ≥ 5 × U L N, ( A L T or 
A S T)  ≥ 1 0 × U L N, ( A L T or A S T)  ≥ 2 0 × U L N  
•  T otal bilir u bi n < 2 × U L N, t otal bilir u bi n ≥ 2 × U L N  
•  A L P ≤ 2 × U L N, A L P > 2 × U L N  
•  C o nc urre nt A L T ≥ 3 × U L N a n d t otal bilir u bi n ≥ 2 × U L N  
•  C o nc urre nt A S T ≥ 3 × U L N a n d t otal bilir u bi n ≥ 2 × U L N  
•  C o nc urre nt ( A L T or A S T)  ≥ 3 × U L N a n d t otal bilir u bi n ≥ 2 × U L N  
•  C o nc urre nt ( A L T or A S T)  ≥ 3 × U L N a n d t otal bilir u bi n ≥ 2 × U L N a n d A L P > 2 × U L N  
•  C o nc urre nt ( A L T or A S T) ≥ 3 × U L N a n d t otal bilir u bi n ≥ 2 × U L N a n d A L P ≤ 2 × U L N or 
missi n g  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
7 4 /8 5  
 
 
C o nc urre nt meas ure me nts are t h ose occ urri n g o n t he sa me date. Cate g ories will be c u m ulati ve, 
i.e., a partici pa nt  wit h a n ele vati o n of A S T ≥1 0 × U L N will als o a p pear i n t he cate g ories ≥5 × U L N 
a n d ≥3 × U L N.  
A pl ot of pea k A L T vers us pea k t otal bilir u bi n, b ot h re lati ve t o t he U L N will be pr o vi de d. T his 
e DI S H pl ot (e val uati o n of dr u g -i n d uce d seri o us he pat ot o xicit y) will be di vi de d i nt o 4 q ua dra nts 
b y t he li nes t hr o u g h A L T ≥ 3 × U L N a n d t otal bilir u bi n ≥2 × U L N. T he left l o wer q ua dra nt is t he n 
c o nsi dere d n or mal or i nsi g nifica nt ele vati o ns i n li ver c he mistries, t he u p per left q ua dra nt i n dicate s 
patie nts wit h p ossi ble Gil bert’s c h olestasis; t he ri g ht u p per q ua dra nt is t he p ossi ble H y’s La w 
patie nts; t he ri g ht l o wer q ua dra nt is p ossi ble Te m ple’s C or ollar y ( patie nts wit h A L T  ≥ 3 x U L N 
b ut n ot satisf yi n g H y’s La w).  A pl ot of pea k A S T vers us pea k t otal bilir u bi n, b ot h relati ve t o t he 
U L N will als o be pr o vi de d . 
I n a d diti o n, a listi n g of all T BI LI, A L T, A S T a n d A L P val ues f or partici pa nt s wit h a p ost-baseli ne 
T BI LI ≥ 2 × U L N, A L T ≥ 3 × U L N or A S T ≥ 3 × U L N will be pr o vi de d, i ncl u di n g val ues e x presse d 
as m ulti ples of U L N. A listi n g t o st u d y s witc hers ma y als o be pr o vi de d.  
Se parate listi n gs of he mat ol o g y a n d bi oc he mistr y will be create d. Eac h listi n g will i ncl u de c o h ort, 
partici pa nt  i de ntifier, a ge, se x, race, first d ose date, last d ose date, la b orat or y para meter ( u nits), 
visit, date, I nter nati o nal S yste m of U nits ( SI) val ue , c ha n ge fr o m baseli ne, l o wer li mits of n or mal 
( L L N), u p per li mits of n or mal ( U L N ), i n dicat or of n or mal ra n ge (l o w, n or mal, hi g h), t o xicit y gra de 
acc or di n g t o N CI -C T C A E a n d hi g hest/l o west o n -treat me nt val ue fla g. T hese listi n gs will be s orte d 
b y c o h ort , pa rtici pa nt i de ntifier, la b orat or y meas ure me nt date, ti me a n d para meter . T he baseli ne 
val ues a n d p ost -baseli ne val ues after t he o n -treat me nt peri o d will be fla g ge d. 
He m ost ase ol o g y, U ri n al ysis  / U ri n al ysis M icr osc o pic E v al u ati o n , H or m o n al T ests, S er ol o g y 
All test res ults f or he m ostase ol o g y, uri nal ysis / uri nal ysis micr osc o pic e val uati o n, h or m o nal tests, 
ser ol o g y will als o be liste d.  
Pre g n a nc y T est 
All test res ults f or pre g na nc y test as c ollecte d o n t he “ Pre g na nc y Test” e C R F pa ge will be liste d.  
1 5. 4  
Vit al Si g ns   
T he f oll o wi n g s u m mar y  will be pre pare d f or vital si g n s:  b o d y te m perat ure, p ulse rate, s yst olic 
bl o o d press ure ( S B P), diast olic bl o o d press ure ( D B P), a n d res pirati o n rate c o nsi deri n g o nl y 
partici pa nt s wit h p ost -baseli ne val ues  d uri n g o n -treat me nt peri o d: 
•  S u m mar y statistics o ver ti me  
P ote ntiall y cli nicall y si g ni fica nt a b n or malities will als o be s u m marize d: 
•  ≤ 9 5 m m H g a n d decrease fr o m baseli ne ≥ 2 0 m m H g i n s yst olic bl o o d press ure  
•  ≥ 1 4 0 m m H g a n d i ncrease fr o m baseli ne ≥ 2 0 m m H g i n s yst olic bl o o d press ure  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
7 5 /8 5  
 
 
•  ≤ 4 5 m m H g a n d decrease fr o m baseli ne ≥ 2 0 m m H g i n diast olic b l o o d press ure 
•  ≥ 9 0 m m H g a n d i ncrease fr o m baseli ne ≥ 2 0 m m H g i n diast olic bl o o d press ure  
•  ≤ 5 0 beats/ mi n a n d decrease fr o m baseli ne ≥ 2 0 beats/ mi n i n heart rate  
•  ≥ 1 0 0 beats/ mi n a n d i ncrease fr o m baseli ne ≥ 2 0 beats/ mi n i n heart rate  
•  ≤ 2 0 breat hs/ mi n a n d dec rease fr o m baseli ne ≥ 5 breat hs/ mi n i n res pirat or y rate 
•  ≥ 2 0 breat hs/ mi n a n d i ncrease fr o m baseli ne ≥ 5 breat hs/ mi n i n res pirat or y rate  
•  ≥ 1 0 % wei g ht i ncrease  
•  ≥ 1 0 % wei g ht decrease  
All vital si g ns will als o be liste d, baseli ne val ues a n d p ost -baseli ne val ues c ollecte d after t he o n -
treat me nt peri o d will be fla g ge d i n t he listi n g. T he listi n g will i ncl u de c o h ort , partici pa nt  i de ntifier, 
a ge, se x, race, vital si g n para meter, u nit, visit , date/ti me, o n-treat me nt fla g, val ue, baseli ne val ue, 
a n d c ha n ge fr o m baseli ne. Listi n gs will be s orte d b y c o h ort , partici pa nt  i de ntifier, vital si g n 
para meter , vital si g n meas ure me nt date  a n d ti me .  
1 5. 5  
Ot her S afet y or T oler a bilit y E v al u ati o ns   
E C O G Perf or m a nce St at us  
E C O G perf or ma nce stat us will be prese nte d i n a listi n g at eac h ti me p oi nt  (see details of t he 
cate g ories i n S ecti o n 1 1. 3. 2 ). T he baseli ne val ues a n d p ost -baseli ne val ues after t he o n -treat me nt 
peri o d will be fla g ge d.  
E C G  
A nal yses of baseli ne c haracteristics wit h res pect t o E C Gs are disc usse d i n Secti o n 1 1. 3 .3 . 
A listi n g of E C G val ues will als o be pr o vi de d wit h t he f oll o wi n g i nf or mati o n: c o h ort , partici pa nt  
i de ntifier, a ge, se x, race, E C G para meter a n d u nit, visit, E C G date  a n d val ue. T he listi n g will be 
s orte d b y c o h ort , partici pa nt  i de ntifier, E C G para meter a n d E C G  date . It will i ncl u de all t he E C G 
val ues c ollecte d d uri n g t he st u d y . 
1 6  
A n al yses of Ot her E n d p oi nts   
1 6. 1  
P h ar m ac o ki netics   
T he a nal yses descri be d i n t his secti o n will be perf or me d b y t he Cli nical P K/ P D gr o u p ( C P K) of 
Tra nslati o nal Me dici ne, Merc k Healt hcare K Ga A, Dar msta dt, Ger ma n y, or b y a C o ntract Researc h 
Or ga nizati o n selecte d b y t he S p o ns or. P har mac o ki netic listi n gs a n d i n di vi d ual data will be 
prese nte d base d o n t he Safet y A nal ysis Set. S u m maries a n d statistical a nal yses will be base d o n 
t he P K A nal ysis Set. 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
7 6 /8 5  
 
 
Partici pa nts 
w h o s witc he d c he m ot hera p y 
will be fla g ge d i n listi n gs. 
P har mac o ki netic 
c o nce ntrati o ns / P K para meters me nti o ne d herei n refer t o t h ose of bi ntraf us p alfa . 
1 6. 1. 1   
Missi n g/ n o n -q u a ntifi a ble P K D at a H a n dli n g   
C o nce ntr ati o ns Bel o w t he L o wer Li mit of Ass a y Q u a ntific ati o n  
P har mac o ki netic c o nce ntrati o ns bel o w t he l o wer li mit of q ua ntificati o n ([ L L O Q] B L Q) are set t o 
zer o f or calc ulati n g para meters a n d descri pti ve statistics.  
P har mac o ki netic c o nce ntrati o ns B L Q w hic h are bef ore t he last q ua ntifia ble data p oi nt will be ta ke n 
as zer o f or calc ulati n g t he A U C of si n gle d ose pr ofiles. C o nce ntrati o ns B L Q w hic h occ ur after t he 
last q ua ntifia ble data p oi nt will n ot be c o nsi dere d i n t he calc ulati o n of t he ter mi nal first or der rate 
c o nsta nt ( λ Z ). 
D e vi ati o ns, Missi n g C o nce ntr ati o ns, a n d A n o m al o us V al ues  
P har mac o ki netic para meters will be calc ulate d usi n g t he act ual ela pse d ti me si nce d osi n g. W he n 
t he act ual sa m pli n g ti me is missi n g, calc ulati o ns will be perf or me d usi n g t he sc he d ule d ti me. 
Ot her wise, t here will be n o f urt her i m p utati o n of missi n g data. C o nce ntrati o ns will be set t o 
missi n g i n s u m mar y ta bles if t he val ue is re p orte d as n o res ult.  
P har mac o ki netic c o nce ntrati o ns w hic h are err o ne o us d ue t o a pr ot oc ol vi olati o n (as defi ne d i n t he 
cli nical st u d y pr ot oc ol a n d/ or Secti o n 8. 1 ), d oc u me nte d ha n dli n g err or, or a nal ytical err or (as 
d oc u me nte d i n t he pr ot oc ol de viati o n l o g, bi oa nal ytical data, a n d/ or bi oa nal ytical re p ort) ma y be 
e xcl u de d fr o m t he P K a nal ysis if a gree d u p o n pri or t o perf or mi n g a statistical a nal ysis. I n t his case 
t he rati o nale f or e xcl usi o n m ust be pr o vi de d i n t he C S R. A n y ot her P K c o nce ntrati o ns t hat a p pear 
i m pla usi ble t o t he P harmac o ki neticist/ P K/ P D Data A nal yst m ust n ot be e xcl u de d fr o m t he 
a nal ysis. A n y i m pla usi ble data will be d oc u me nte d i n t he C S R.  
If a P K para meter ca n n ot be deri ve d fr o m a partici pa nt’s c o nce ntrati o n data, t he para meter will be 
c o de d as N C ( n ot calc ulate d) ( N ote t hat N C val ues will n ot be ge nerate d be y o n d t he da y t hat a 
partici pa nt disc o nti n ues t he treat me nt). F or statistical a nal yses (i.e. , descri pti ve statistics), P K 
para meters c o de d as N C will be set t o missi n g.  
If a n i n di vi d ual partici pa nt has a k n o w n biase d esti mate of a P K para meter ( d ue f or e xa m ple t o a 
de viati o n fr o m t he assi g ne d d ose le vel), t his partici pa nt / val ue will be e xcl u de d fr o m t he 
descri pti ve statistics base d o n t he P K A S a n d i nstea d t he res ult will be liste d o nl y.  
Rele va nt decisi o ns o n parti ci pa nt i ncl usi o n i n t he P K a nal ysis set will be ma de bef ore data base 
l oc k i n t he Data base Re vie w Meeti n g. 
1 6. 1. 2   
Descri pti ve P K A n al ysis   
Prese nt ati o n of P K C o nce ntr ati o n D at a  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
7 7 /8 5  
 
 
Listi n gs  
I n di vi d ual P K sa m ple ti mes, ti me de viati o ns, a n d c o nce ntrati o n data will be liste d b y part, 
partici pa nt, c o h ort, st u d y da y, a n d n o mi nal ti me. C o nce ntrati o n listi n gs will be base d o n t he S A F. 
P har mac o ki netic c o nce ntrati o ns will be re p orte d wit h t he  sa me precisi o n as t he s o urce data 
pr o vi de d b y t he bi oa nal ytical la b orat or y. Act ual ela pse d sa m ple c ollecti o n ti mes will be r o u n de d 
t o t w o deci mal places wit h u nits of h o urs f or re p orti n g p ur p oses i n listi n gs. 
T a bles  
P har mac o ki netic  c o nce ntrati o n data will  be prese nte d i n ta bles a n d descri pti vel y s u m marize d f or 
t he P K A S i n safet y part o nl y/first d ose b y c o h ort, 1 L C o h ort A, B, C, o verall (all c o h orts), da y, 
a n d n o mi nal ti me usi n g: n u m ber of n o n -missi n g o bser vati o ns ( n), arit h metic mea n ( Mea n), St D, 
c oefficie nt of variati o n ( C V %), 
Mi n, me dia n ( Me dia n), a n d 
Ma x. A d diti o nal ta ble(s) will 
s u m marize wit h f urt her stratificati o n b y A D A s u b gr o u ps e ver p ositi ve a n d ne ver p ositi ve. O nl y 
A D A s u b gr o u p sa m ple size wit h a mi ni m u m of 3 partici pa nts  will be dis pla ye d. S u m maries of 
pre -d ose a n d e n d -of -i nf usi o n c o nce ntrati o ns ot her t ha n first d osi n g i nter val will be c o vere d b y t he 
para meter s u m maries o nl y.  
Descri pti ve statistics of P K c o nce ntrati o n data will be calc ulate d usi n g val ues wit h t he sa me 
precisi o n as t he s o urce  data pr o vi de d b y t he bi oa nal ytical la b orat or y a n d r o u n de d f or re p orti n g 
p ur p oses o nl y. T he f oll o wi n g c o n ve nti o ns will be a p plie d w he n re p orti n g descri pti ve statistics of 
P K c o nce ntrati o n data:  
Mea n, Mi n, Me dia n, Ma x:  
  
3 si g nifica nt di gits  
St D:  
  
  
  
  
4 si g n ifica nt di gits 
C V %:    
  
  
  
1 deci mal place  
Fi g ures  
I n di vi d ual P K c o nce ntrati o n-ti me pr ofiles s h o wi n g all partici pa nts b y part a n d c o h ort will be 
create d f or serial sa m pli n g (i.e. , safet y part, first d ose) usi n g t he act ual ti me p oi nts a n d t he n u meric 
c o nce ntr ati o n data. Arit h metic mea n a n d me dia n c o nce ntrati o n -ti me pr ofiles b y c o h ort, 1 L C o h ort 
A, B, C,  a n d o verall (all c o h orts c o m bi ne d)  f or serial sa m pli n g (i.e., safet y part, first d ose) will be 
pr o vi de d usi n g sc he d ule d ( n o mi nal) ti me p oi nts a n d t he n u meric c o nce ntrati o n data. All 
c o nce ntrati o n -ti me pl ots f or P K data will be prese nte d b ot h o n a li near a n d o n a se mi-l o garit h mic 
scale. Mea n P K pl ots will i ncl u de St D err or bars w he n pl otte d o n a li near scale. I n di vi d ual data 
will be prese nte d base d o n t he S A F, a n d s u m maries will be base d o n t he P K A S. A d diti o nal 
fi g ure(s) will be prese nte d wit h f urt her stratificati o n b y A D A s u b gr o u ps e ver p ositi ve a n d ne ver 
p ositi ve. O nl y A D A s u b gr o u p sa m ple size wit h a mi ni m u m of 3 partici pa nts  will be dis pla ye d. 
Fi g ures of pre -d o se a n d e n d-of -i nf usi o n c o nce ntrati o ns ot her t ha n first d osi n g i nter val will be 
c o vere d b y t he para meter s u m maries o nl y.  
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
7 8 /8 5  
 
 
1 6. 1. 3   
P h ar m ac o ki netic N o n -C o m p art me nt al A n al ysis   
Prese nt ati o n of  P K P ar a meter D at a  
Listi n gs  
I n di vi d ual P K para meter data will be liste d b y part, partici pa nt, c o h ort, a n d st u d y da y. Para meter 
listi n gs will be base d o n t he S A F. P har mac o ki netic para meters will be re p orte d t o 3 si g nifica nt 
di gits i n listi n gs.  
T a bles  
P har ma c o ki netic para meter data will be prese nte d i n ta bles a n d descri pti vel y s u m marize d f or t he 
P K A S b y part, c o h ort, 1 L C o h ort A, B, C, o verall b y part (all c o h orts wit hi n eac h part), o verall 
(all parts/c o h orts), a n d da y usi n g: n, Mea n, St D, C V %, Mi n, Me dia n, M a x, ge o metric mea n 
( Ge o Mea n), t he ge o metric c oefficie nt of variati o n ( Ge o C V %), a n d t he 9 5 % CI f or t he Ge o Mea n. 
A d diti o nal ta ble(s) will s u m marize wit h f urt her stratificati o n b y A D A s u b gr o u ps e ver p ositi ve a n d 
ne ver p ositi ve. O nl y A D A s u b gr o u p sa m ple size w it h a mi ni m u m of 3 partici pa nts  will be 
dis pla ye d.  
I n e x p ort datasets, as well as i n t he S D T M P P d o mai n, P K para meters will be pr o vi de d wit h f ull 
precisi o n a n d will n ot be r o u n de d. Descri pti ve statistics of P K para meter data will be calc ulate d 
usi n g f ull p recisi o n val ues a n d r o u n de d f or re p orti n g p ur p oses o nl y.  
T he f oll o wi n g c o n ve nti o ns will be a p plie d w he n re p orti n g descri pti ve statistics of P K para meter 
data:  
Mea n, Mi n, Me dia n, Ma x, Ge o Mea n, 9 5 % CI:   
3 si g nifica nt di gits  
St D:  
  
  
  
  
  
  
4 si g nifica nt di gits  
C V %, Ge o C V %:   
  
  
  
  
1 deci mal place  
T he P K para meters liste d bel o w will be calc ulate d f or bi ntraf us p alfa usi n g t he act ual ti me ela pse d 
fr o m d osi n g ( or usi n g sc he d ule d ti me if act ual ti me is n ot a vaila ble, e. g., a n y a nal yses pri or t o fi nal 
a nal ysis). P har mac o ki netic c o nce ntrati o ns will be a nal yze d wit h t he sa me precisi o n as t he s o urce 
data pr o vi de d b y t he bi oa nal ytical la b orat or y. Act ual ela pse d sa m ple c ollecti o n ti mes will be 
a nal yze d u nr o u n de d ( ma xi m u m of 1 4 si g nifica nt di gits). T he pre -d ose sa m ples will be c o nsi dere d 
as if t he y ha d bee n ta ke n si m ulta ne o usl y wit h t he start of i nf usi o n (i.e., ti me zer o).  
C e oi 
T he c o nce ntrati o n o bser ve d i m me diatel y at t he e n d of i nf usi o n. 
T his will be ta ke n directl y fr o m t he o bser ve d bi ntraf us p alfa 
c o nce ntrati o n-ti me data. 
C tr o u g h 
T he c o nce ntrati o n o bser ve d i m me diatel y bef ore ne xt d osi n g 
(c orres p o n di n g t o pre-d ose or tr o u g h c o nce ntrati o n f or m ulti ple 
d osi n g).  T his will be ta ke n directl y fr o m t he o bser ve d bi ntraf us p 
alfa c o nce ntrati o n -ti me data. 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
7 9 /8 5  
 
 
A U C 0 -t 
Area u n der t he c o nce ntrati o n -ti me c ur ve ( A U C) fr o m ti me zer o 
(i.e., i nf usi o n start ti me) t o t he last sa m pli n g ti me (t last) at w hic h 
t he c o nce ntrati o n is at or a b o ve t he l o wer li mit of q ua ntificati o n. 
( Safet y part o nl y; first d ose o nl y) 
A U C 0 -∞ 
T he A U C fr o m ti me zer o (i nf usi o n start ti me) e xtra p olate d t o 
i nfi nit y, base d o n t he pre dicte d val ue f or t he c o nce ntrati o n at tlast 
( Clast pre d), as esti mate d usi n g t he li near re gressi o n fr o m λ Z  
deter mi nati o n.  A U C 0 -∞ = A U C 0 -t+ C last pre d/ λZ . ( Safet y part o nl y; 
first d ose o nl y) 
t1/ 2 
A p pare nt ter mi nal (eli mi nati o n) half -life, calc ulate d b y l n 2/ λZ . 
( Safet y part o nl y; first d ose o nl y) 
λ Z  
Ter mi nal first or der (eli mi nati o n) rate c o nsta nt, deter mi ne d fr o m 
t he ter mi nal sl o pe of t he l o g-tra nsf or me d c o nce ntrati o n-ti me c ur ve 
usi n g li near re gressi o n o n ter mi nal data p oi nts of t he c ur ve. ( Safet y 
part o nl y; first d ose o nl y)  
C ma x   
Ma xi m u m o bser ve d c o nce ntrati o n. ( Safet y part o nl y; first d ose 
o nl y)  
tma x  
T he ti me t o reac h t he ma xi m u m o bser ve d c o nce ntrati o n c ollecte d 
d uri n g a d osi n g i nter val ( u nless ot her wise defi ne d, ta ke t he 1st 
occ urre nce i n case of m ulti ple/i de ntical C ma x  val ues). ( Safet y part 
o nl y; first d ose o nl y)  
C L  
T otal b o d y cleara nce. C L = D ose/ A U C 0 -∞. ( Safet y part o nl y; first 
d ose o nl y)  
 
 
V z 
V ol u me 
of 
distri b uti o n 
d uri n g ter mi nal 
p hase f oll o wi n g 
i ntra ve n o us d osi n g. Vz = D ose/( A U C 0 -∞* λ Z ). ( Safet y part o nl y; 
first d ose o nl y) 
T he f oll o wi n g P K para meters ( Safet y part o nl y; first d ose o nl y) will be calc ulate d f or dia g n ostic 
p ur p oses a n d liste d, b ut will n ot be s u m marize d:  
•  T he ti me i nter val ( h) of t he l o g -li near re gressi o n t o deter mi ne λZ  (t1/ 2, I nter val). 
•  T he starti n g ti me p oi nt ( h) of t he ti me i nter val of t he l o g -li near re gressi o n t o deter mi ne z 
( La m b da _z _l o w). 
•  T he e n di n g ti me p oi nt ( h) of t he ti me i nter val of t he l o g -li near re gressi o n t o deter mi ne z 
( La m b da _z _ u p p). 
•  N u m ber of data p oi nts (t 1/ 2, N) i ncl u de d i n t he l o g-li near re gressi o n a nal ysis t o deter mi ne 
λ Z . 
•  G o o d ness -of -fit statistic (a dj uste d Rs q) f or calc ulati o n of λZ . 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
8 0 /8 5  
 
 
•  Perce nta ge of 
A U C 0 - o btai ne d b y e xtra p olati o n ( A U C e xtra %), calc ulate d b y ( 1－
[ A U C0 -t/ A U C0 -]) × 1 0 0.   
T he re gressi o n a nal ysis ( deter mi nati o n of z) s h o ul d c o ntai n as ma n y data p oi nts as p ossi ble ( b ut 
e xcl u di n g C ma x ) a n d has t o i ncl u de c o nce ntrati o n data fr o m at least 3 differe nt ti me p oi nts, 
c o nsiste nt wit h t he assess me nt of a strai g ht li ne (t he ter mi nal eli mi nati o n p hase) o n t he 
l o g-tra nsf or me d scale. T he o bser vati o n peri o d o ver w hic h t he re gressi o n li ne is esti mate d s h o ul d 
be at least  t w o-f ol d t he res ulti n g t1/ 2 itself. If A U C e xtra % > 2 0. 0 % a n d/ or a dj uste d Rs q  of λ Z  is < 0. 8 0 0 
a n d/ or t1/ 2, I nter val is less t ha n t w of ol d t he res ulti n g t1/ 2, t he n λ Z  a n d all deri ve d para meters (e. g. , 
t1/ 2, A U C 0 -∞, C L, etc.) will be liste d a n d fla g ge d b ut e xc l u de d fr o m descri pti ve statistics. 
T he calc ulati o n of t he A U Cs will be perf or me d usi n g t he mi xe d l o g -li near tra pez oi dal met h o d 
(li near u p, l o g d o w n). E xtra p olate d areas will al wa ys be c o m p ute d usi n g t he pre dicte d last 
c o nce ntrati o n t hat is esti mate d usi n g t he li near re gressi o n fr o m ter mi nal rate c o nsta nt 
deter mi nati o n.  
Fi g ures  
I n di vi d ual P K tr o u g h c o nce ntrati o n ( Ctr o u g h) a n d e n d of i nf usi o n c o nce ntrati o n ( Ce oi) val ues will be 
pl otte d a gai nst act ual st u d y da y o n a li near scale, f or all partic i pa nts b y part a n d c o h ort i ncl u di n g 
t he c o m bi ne d 1 L C o h ort A, B, C. I n di vi d ual data will be prese nte d base d o n t he S A F. 
Arit h metic mea n ( ± St D) , ge o metric mea n, a n d me dia n C tr o u g h a n d C e oi will be pl otte d vers us 
n o mi nal st u d y da y b y part, c o h ort , o verall b y part (all c o h orts wit hi n eac h part), a n d o verall (all 
parts/c o h orts)  o n a li near scale. S u m maries will be base d o n t he P K A S. A d diti o nal fi g ure(s) will 
be prese nte d wit h f urt her stratificati o n b y A D A s u b gr o u ps e ver p ositi ve a n d ne ver p ositi ve. O nl y 
A D A s u b gr o u p sa m ple size wit h a mi ni m u m of 3 partici pa nts  will be dis pla ye d. S u m mar y fi g ures 
of mea n or me dia n will c o ntai n a f o ot n ote de n oti n g n per ti me p oi nt.  
T he P h oe ni x Wi n N o nli n n o n -c o m part me ntal C ore O ut p ut will be pr o vi de d i n a se parate listi n g.  
 
  
 
1 6. 3  
I m m u n o ge nicit y  
T he I M M a nal ysis set will be use d t o e val uate t he i m m u n o ge nic it y of bi ntraf us p alfa . Res ults will 
be dis pla ye d b y c o h ort a n d c o m bi ne d 1 L C o h ort A, B, C.  
A nti dr u g a nti b o d y ( A D A) will be assesse d pri or t o bi ntraf us p alfa i nf usi o ns. Sa m ples c ollecte d 
after t he o n -treat me nt peri o d (e. g., safet y f oll o w-u p) will be i ncl u de d i n t he a nal ysis as well. If t he 
sa m ple is p ositi ve f or A D A, it will be re-a nal yze d t o deter mi ne t he titer. T he A D A res ults will be 
deri ve d base d o n t he al g orit h m i n  Ta ble 6 . 
Gl o bal Versi o n I D: C CI
C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
8 1 /8 5  
 
 
T a ble 6    
Al g orit h m f or t he Deri v ati o n of A D A Res ults   
S a m pl e S cr e e n R e s ult   
C o nfir m at or y  
Tit er  
A D A R e s ult  
N e g ati v e  
N A  
N A  
N e g ati v e  
N R  
N A  
N A  
N R  
P o siti v e  
N e g ati v e  
N A  
N e g ati v e  
P o siti v e  
N R  
N A  
N R  
P o siti v e  
P o siti v e  
N u m b er  
N u m b er  
P o siti v e  
P o siti v e  
N R  
P o siti v e -T N R  
N R = n o r e s ult, N A = n ot a p pli c a bl e, T N R = tit er n o r e s ult.  
Ne gati ve, n u m ber, or p ositi ve -T N R are vali d res ults w hile n u m ber a n d p ositi ve -T N R are 
c o nsi dere d as p ositi ve. Partici pa nt s will be c haracterize d i nt o differe nt cate g ories base d o n t he 
criteria i n t he ta ble bel o w (Ta ble 7 ). 
T a ble 7    
P artici p a nts C h ar acterize d b ase d o n A D A Res ults   
C at e g or y   
D efi niti o n  
P arti ci p a nt at Ri s k ( D e n o mi n at or f or 
I n ci d e n c e) 
N e v er 
p o siti v e  
N o p o siti v e r e s ult s at a n y ti m e p oi nt  
N u m b er of p arti ci p a nt s wit h at l e a st o n e v ali d 
A D A r e s ult at a n y ti m e p oi nt 
E v er p o siti v e   
At l e a st o n e p o siti v e r e s ult at a n y ti m e p oi nt, 
i n cl u di n g b a s eli n e 
N u m b er of p arti ci p a nt s wit h at l e a st o n e v ali d 
A D A r e s ult at a n y ti m e p oi nt 
Pr e -e xi sti n g  
A p o siti v e A D A r e s ult pri or t o tr e at m e nt wit h 
bi ntr af u s p alf a  
N u m b er of p arti ci p a nt s wit h v ali d b a s eli n e 
A D A r e s ult 
Tr e at m e nt 
b o o st e d  
A p o s iti v e A D A r e s ult pri or t o tr e at m e nt wit h 
bi ntr af u s p alf a  a n d t h e tit er ≥ 8* b a s eli n e tit er at 
l e a st o n e p o st-b a s eli n e v al u e  
N u m b er of p arti ci p a nt s  wit h a v ali d b a s eli n e 
A D A r e s ult a n d at l e a st o n e v ali d p o st-
b a s eli n e A D A r e s ult 
 
Tr e at m e nt 
e m er g e nt  
(i n d u c e d) 
N ot p o siti v e pri or t o tr e at m e nt (i n cl u d e s mi s si n g or 
N R ) wit h bi ntr af u s p alf a  a n d wit h at l e a st o n e 
p o siti v e p o st -b a s eli n e r e s ult  
N u m b er of p arti ci p a nt s  wit h at l e a st o n e v ali d 
p o st -b a s eli n e A D A r e s ult a n d wit h o ut p o siti v e 
A D A b a s eli n e r e s ult  (i n cl u di n g mi s si n g, N R) 
 
Tr e at m e nt 
e m er g e nt  
( A L L) 
Tr e at m e nt e m er g e nt pl u s T r e at m e nt b o o st e d  
 
N u m b er of p arti ci p a nt s  wit h at l e a st o n e v ali d 
p o st -b a s eli n e A D A r e s ult  
 
 
A D A N o n -
Tr e at m e nt -
e m er g e n  
All p arti ci p a nt s  at ri s k mi n u s Tr e at m e nt  e m er g e nt 
( A L L) 
 
N u m b er of p arti ci p a nt s  wit h at l e a st o n e v ali d 
p o st -b a s eli n e A D A r e s ult  
 
 
Tr a n si e nt 
p o siti v e  
If tr e at m e nt e m er g e nt p arti ci p a nt s h a v e  
- a si n gl e p o siti v e e v al u ati o n  
or  
- d ur ati o n b et w e e n fir st a n d l a st p o siti v e r e s ult < 1 6 
w e e k s  
a n d l a st a s s e s s m e nt n ot p o siti v e  
N u m b er of p arti ci p a nt s  wit h at l e a st o n e v ali d 
p o st -b a s eli n e A D A r e s ult a n d wit h o ut p o siti v e 
b a s eli n e A D A r e s ult (i n cl u di n g mi s si n g, N R) 
 
Gl o bal Versi o n I D: C CI


 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
8 2 /8 5  
 
 
P er si st e nt 
p o siti v e  
If tr e at m e nt e m er g e nt p arti ci p a nt s h a v e d ur ati o n 
b et w e e n fir st a n d l a st p o siti v e r e s ult ≥1 6 w e e k s or 
a p o siti v e e v al u ati o n at t h e l a st a s s e s s m e nt  
N u m b er of p arti ci p a nt s  wit h at l e a st o n e v ali d 
p o st -b a s eli n e A D A r e s ult a n d wit h o ut p o siti v e 
b a s eli n e A D A r e s ult (i n cl u di n g mi s si n g, N R) 
 
St art of I m m u n o ge nicit y Res p o nse  
•  F or partici pa nts wit h treat me nt -e mer ge nt res p o nse, t he date of t he first assess me nt wit h 
p ositi ve A D A res ult will be c o nsi dere d as start date of A D A res p o nse.  
•  F or partici pa nts wit h treat me nt -b o oste d res p o nse, t he date of t he first b o oste d assess me nt 
(i.e., first p ost-baseli ne date w here titer ≥ 8  * baseli ne titer) will be c o nsi dere d as start 
date of A D A res p o nse.  
Ti me t o O nset of R es p o nse f or T re at me nt  E mer ge nt  A L L  
Ti me t o o nset ( wee ks) of A D A res p o nse will be calc ulate d as:  
•  ( Date of first p ositi ve A D A assess me nt –  start date of bi ntraf us p alfa treat me nt + 1) / 7 
f or treat me nt-e mer ge nt partici pa nts  
•  ( Date of first b o oste d (titer ≥ 8 * baseli ne titer) A D A assess me nt –  start date of bi ntraf us p 
alfa treat me nt + 1) / 7 f or treat me nt b o oste d partici pa nts  
D ur ati o n of A D A Res p o nse f or T re at me nt  E mer ge nt  A L L  
D urati o n of A D A i m m u n o ge nicit y res p o nse ( wee ks) is defi ne d as:  
•  ( Date of last p ositi ve A D A assess me nt –  date of first p ositi ve A D A assess me nt + 1) / 7 f or 
treat me nt-e mer ge nt partici pa nts  
•  ( Date of last p ositi ve AD A assess me nt - date of first b o oste d (titer ≥ 8  * baseli ne titer) 
A D A assess me nt + 1) / 7 f or treat me nt b o oste d partici pa nts  
P ote ntial effect of A D A o n safet y, efficac y a n d P K will be e val uate d o n A D A p ositi ve stat us (e ver 
p ositi ve  vers us  ne ver p ositi ve , a n d treat me nt-e mer ge nt A L L  vers us n o n -treat me nt e mer ge nt A L L ). 
T he f oll o wi n g a nal ysis will be descri be d:  
•  T he fre q ue nc y a n d perce nta ge of eac h A D A cate g or y will be ta b ulate d . 
•  T he A D A titer val ue b y ti me p oi nt will be s u m marize d . 
•  T he ma xi m u m o bser ve d A D A titer per partici pa nt will be ta b ulate d  (as q ua ntitati ve a n d 
cate g orical varia ble) . F or eac h discrete titer val ue, perce nta ges will be calc ulate d usi n g t he 
t otal n u m ber of partici pa nts wit h at least o ne p ositi ve res ult as t he de n o mi nat or . 
•  T he ti me t o o nset of  res p o nse f or treat me nt -e mer ge nt AL L  partici pa nts will be s u m marize d . 
Gl o bal Versi o n I D: C CI






 
Bi ntr af us p alf a ( M 7 8 2 4 )    Bi ntr af us p alf a i n C o m bi n ati o n wit h C he m ot her a p y i n St a ge I V N S C L C 
M S 2 0 0 6 4 7 _ 0 0 2 4   
  
  
  
  
  
  
  
  
Versi o n N o. 3 .0  
 
 
C O N F I D E N T I A L  
I N F O R M A T I O N 
8 5 /8 5  
 
 
1 8  
A p pe n dices   
1 8. 1  
A p pe n di x 1: List of Im p ort a nt P r ot oc ol D e vi ati o ns   
See d oc u me nt: ct p-e mr 2 0 0 6 4 7 -0 0 2 4 -ia p-a p pe n di x-1.  
1 8. 2  
A p pe n di x 2: 
I de ntific ati o n of P re vi o us or C o nc o mit a nt 
M e dic ati o ns   
See d oc u me nt:  ct p-e mr 2 0 0 6 4 7 -0 0 2 4 -ia p-a p pe n di x-2 . 
1 8. 3  
A p pe n di x 3: Defi niti o n of N CI -C T C A E G r a di n g   
See d oc u me nt:  C T C V 5. 0 g ui da nce. xls x . 
Gl o bal Versi o n I D: C CI