ARIA: Real-world Utilization and Outcomes With Dacomitinib First-line Treatment for EGFR Mutation-positive Advanced Non-small Cell Lung Cancer Among Asian Patients - A Multi-center Chart Review
Conditions: Lung Cancer
Sponsor: Pfizer

Da c o miti ni b ( VI ZI M P R O® ) 
A 7 4 7 1 0 6 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
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N O N -I N T E R V E N TI O N A L ( NI) S T U D Y P R O T O C O L 
St u d y  i nf o r m ati o n 
Title  
A RI A: Re al -w orl d utiliz ati o n a n d o utc o m es wit h 
d a c o miti ni b first -li n e tre at m e nt f or E G F R 
m utati o n -p ositi v e a d va nc e d n o n -s m all c ell l u n g 
c a n c er a m o n g Asia n p atie nts – A m ulti -c e nter 
c h art re vie w  
P r ot o c ol n u m be r  
A 7 4 7 1 0 6 7  
Pr ot o c ol v e rsi o n i de ntifie r  
3. 0  
D ate  
1 0 J a n 2 0 2 2 
E U P ost A ut h o riz ati o n St u d y ( P A S) 
r e giste r n u m be r  
E U P A S 4 4 5 4 3  
A cti v e su bst a nc e  
Pr otei n ki n as e i n hi bit or ( A T C c o d e: L 0 1 X E) , 
D a c o miti ni b ( A T C  c o d e: L 0 1 X E 4 7)  
M e dici n al pr o d uct  
D a c o miti ni b ( VI ZI M P R O ® ) 
R es e a r c h q uesti o n a n d o bje cti v es  
T h e o v erall o bje cti v e is t o d es cri b e t h e cli nic al 
a n d dis e as e c h ara cteristics, t h era pe utic p atter ns of 
d a c o miti ni b utiliz ati o n  a n d  o utc o mes i n  a n Asia n 
a d v a n c e d n on- s mall c ell l u n g ca n c er ( N S C L C) 
e pid er m al gr o wt h f a ct or re c e pt or ( E G F R) 
m utati o n -p ositi v e p o p ulati o n tre ate d wit h 
d a c o miti ni b as a first -li n e tre at m e nt. 
A ut h o r  
, P h D 
, Pfiz er E m er gi n g 
Mar k et 
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, Pfiz er Patie nt H e alt h a n d I m p act 
 
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Da c o miti ni b ( VI ZI M P R O® ) 
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, P h D  
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, M B B S, P h D  
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T his d o c u me nt c o nta i ns c o nfide ntial i nf or mati o n b el o n gi n g t o Pfiz er.  E x c e pt as ot her wise a gre e d t o i n 
writi n g, b y a c c e pti n g or re vie wi n g t his d o c u ment, y o u a gre e t o  h ol d t his i nf or mati o n i n c o nfi d en ce a n d n ot 
c o p y or discl ose it t o ot h ers (ex ce pt w h ere re q uire d b y a p plic a ble la w) or use it f or u n a ut h oriz e d p ur p oses.  I n 
t h e e v e nt of a n y a ct ual or s us p e ct ed brea c h of t his o bli gati o n, Pfiz er m ust b e pr o m ptl y n otifie d. 
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090177e1996fe97b\Final\Final On: 19-Sep-2022 18:18 (GMT)

Da c o miti ni b ( VI ZI M P R O® ) 
A 7 4 7 1 0 6 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
P r ot o c ol v ersi o n: 3. 0, 1 0 Ja n 2 0 2 2  
 
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI - GL0 2 -R F 0 2  2. 0 N o n -I nt erv enti on a l St u dy P r ot oc ol Te m pl ate F or S e co n d ary D at a C oll ecti o n St u dy  
0 1 -J u n-2 0 2 0   
Pa ge  8 of 4 7  
4.  A B S T R A C T 
Title:  A RI A: Re al -w or l d utiliz ati o n a n d o utc o m es wit h d a c o miti ni b first-li n e tre at m e nt f or 
E G F R m utat i o n-p ositi v e  a d va nc e d n o n -s m all c ell l u n g c a n c er a m o n g Asia n p atie nts  
– A m ulti -c enter  c h art re vie w  
V e rsi o n ( d ate) of pr ot o c ol : 3. 0 ( 1 0 J a n 2 0 2 2 )  
N a me (affili ati o n ) of m ai n a ut h o rs:
 ( Pfiz er); 
 ( Pfizer) 
 (I Q VIA) ; 
 (I Q VI A) 
R ati o n ale a n d b a c k g r o u n d  
D a c o miti ni b, a s e c o n d -ge nerati o n i rre v ersi ble e pi der m al gr o wt h f a ct or re c e pt or ( E G F R)  
t yrosi n e ki n as e i n hi bit or ( T KI), w as a p pr o v e d b y t h e U nite d States ( U. S.) F o o d a n d Dr u g 
A d mi nistrati o n ( F D A) as tre at m e nt f or a d v a nc e d n o n -s m all c ell l u n g c a n c er ( N S C L C) wit h 
E G F R  e x o n 1 9 d eleti o n or e x o n 2 1 L 8 5 8 R s u bstit uti o n m utati o ns .  I n t h e A R C H E R 1 0 5 0 
ra n d o miz e d trial, a statistic all y si g nific a nt i m pr o ve me nt i n pr o gressi o n-fre e s ur vi val ( P FS) 
w as o bs er v e d wit h d a c o miti ni b c o m pa re d t o gefiti ni b .  
T h ere is c urre ntl y a  p a u cit y of i nf or m a ti o n o n t h e re al-w orl d utiliz ati o n of d a c o miti ni b  a n d 
ass o ciate d cli nic al o utc o mes a m o n g Asia n  p atie nts wit h E G F R  m utati o n -p ositi v e a d v a nc e d  
N S C L C.  U n d ersta n di n g t h e c h ara cteristics, dr u g utiliz atio n a n d  o utc o mes of t h es e p atie nts 
pres c ri b e d wit h d a c o mitin i b re pres e nts a n  i m p orta nt ste p t o w ar ds a d dressi n g t h e e xisti n g 
k n o wle d ge ga ps.  
T h is n o n-i nter v e nti o nal st u d y is d esi g n ate d as a P ost -A ut h oriz ati o n Safet y St u d y ( P A S S) an d 
is a c o m mi t me n t t o t h e N a ti o n al Me dic al Pr o d u cts A d mi nistrati o n ( N M P A)’s Ce nter f or  
Dr u g E v al u ati o n ( C D E)  of C hi n a.  
R es e a r c h o bje cti v es  
T h e pri m ar y o bj e cti v es are: 
1.  T o d es cri b e d e m o gra p hics, as w ell as cli nic al a n d dis e as e c h ar a cteristics of p atie nts  
o n fir st-li n e d a c o miti ni b t h era p y f or tre at m e nt of E G F R m u tati o n-p ositi v e a d va n ce d 
N S C L C . 
2.  T o d es cri b e starti n g d os e of d a c o miti ni b as first -li n e t h era p y, d ose m o dific atio n (if 
a n y), relate d ti mi n g a n d re as o n f or d os e m o dific ati o n, i nterr u pti o n or dis c o nti n u ati o n . 
3.  T o d es cri b e d urati o n o f d ac o miti ni b t h era p y a n d tim e -t o-tre atm e nt f ail ure  ( T T F). 
T h e s e c o n d ar y o bjec tiv es are:  
4.  T o d es cri b e re al-w orl d P F S of p atie nts . 
0 9 0 1 7 7 e 1 9 9 6f e 9 7 b\ Fi n al\ Fi n al O n: 1 9- S e p- 2 0 2 2 1 8: 1 8 ( G M T)
P P D
P P D
P P D
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090177e1996fe97b\Final\Final On: 19-Sep-2022 18:18 (GMT)

Da c o miti ni b ( VI ZI M P R O® ) 
A 7 4 7 1 0 6 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
P r ot o c ol v ersi o n: 3. 0, 1 0 Ja n 2 0 2 2  
 
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI - GL0 2 -R F 0 2  2. 0 N o n -I nt erv enti on a l St u dy P r ot oc ol Te m pl ate F or S e co n d ary D at a C oll ecti o n St u dy  
0 1 -J u n-2 0 2 0   
Pa ge  4 0  of 4 7  
a c t u al d ate of o c c urre n c e wit hi n t h e m o nt h / y e ar of o cc urre n ce i n t h e d a y / m o nt h/y e ar 
( D D/ M M M/ Y Y Y Y ) for m at.  
All res e arc h staff m e m b ers m ust c o m plete t h e f o ll o wi n g Pfiz er trai ni n g re q uire m ents:  
•  “ Y R R Tr ai ni n g f or Ve n d ors W or ki n g o n  Pfiz er St u dies (e x cl u di n g i nter v e ntio n al 
cli nic al s t u dies a n d n o n-i nter v e nti o n al pri m ary d at a c olle cti o n st u dies wit h 
sites/i n v esti g at ors”).  
T h es e trai ni n gs m ust b e c o m plete d b y r e s e arc h staff m e m bers pri or t o t h e start of d ata 
c olle ctio n.  All trai ni n gs i n cl u d e a “ C o nfir mati o n of Trai n i n g C ertific ate ” (for si g n at ure b y 
t h e trai n e e) as a re c or d of c o mpleti o n of t h e trai ni n g, w hi c h m ust b e k e pt i n a retrie v a ble 
f or m at.  C o pies of all si g n e d trai ni n g c ertific ates m ust b e pr o vide d t o Pfiz er .  Re-trai ni n g 
m ust b e c o m plete d o n a n a n n u al b asis  usi n g t h e m ost c urre nt Y o ur Re p orti n g 
Res p o nsi bilities trai ni n g m ateria ls. 
T a ble  5. 
P h a r m a c o vi gil a nc e C o nt a cts of Pfiz e r fo r E a c h C o u nt r y  
C o u ntr y  
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1 0 8 0 0 7 1 4 -1 8 0 6 
  
1 0 8 0 0 1 4 0 -1 8 3 8 
 
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C H N. A E Re p orti n g @ pfiz er. c o m  
I n dia 
T oll -Fre e (l o c al): 0 0 0 8 0 0 1 0 0 -
5 9 6 1  
Alt. 1: + 9 1 2 2 3 9 1 9 -7 7 1 4  
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Mala ysia  
T oll -free (l o c al): 1 8 0 0-8 1 -6 4 3 2  
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Alt. 2: + 1 9 7 3 -6 6 0 -8 9 4 2  
M Y S. A E Re p orti n g @ pfiz er. c o m  
 
 
1 2.  P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A T I NG S T U D Y  R E S U L T S 
I n t h e e v e nt of a n y pr o hi biti o n o r restricti o n i m p os e d (e. g., clini c al h ol d) b y a n a p plic a ble 
c o m p ete n t a ut h orit y i n a n y are a of  t h e w orl d, or  if t h e i n v esti gat or is a w are of a n y n e w 
i nf or mati o n whic h mi g ht i nfl u e nc e t h e e v al u ati o n of t h e b e n efits a n d ris ks of  a Pfi z er 
pr o d u ct , Pfiz er s h o ul d b e i nf or me d i m m e diatel y.   
0 9 0 1 7 7 e 1 9 9 6f e 9 7 b\ Fi n al\ Fi n al O n: 1 9- S e p- 2 0 2 2 1 8: 1 8 ( G M T)
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Da c o miti ni b ( VI ZI M P R O® ) 
A 7 4 7 1 0 6 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
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A N N E X 2. A D DI TI O N A L I N F O R M A TI O N  
A n ne x 2 A.  D es c ri pti o n of t he E aste r n C o o pe r ati v e O nc ol o g y G r o u p ( E C O G) 
Pe rf o r m a nc e St at us  
G r a de  
D es c ri pti o n  
Gra d e 0  
F ull y a cti v e, a ble t o c arr y o n all pre -dis e as e p erf or m a n ce  wit h o ut 
restricti o n. 
Gra d e 1  
Restricte d i n p h ysic all y stre n u o us a cti vit y b ut a m b ulat or y a n d a ble t o 
c arr y o ut w or k of a li g ht o r s e d e ntar y n at ure, e g, li g ht h o us e w or k, 
offic e w or k.  
Gra d e 2  
A m b ulat or y a n d c a pa ble of all s elf care b ut u na ble t o c arr y o u t a n y w or k 
a c ti vities; u p a n d a b o ut m ore t h a n 5 0 % of w a ki n g h o urs. 
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Ca p a ble o f o nl y li mite d s elfc are; c o nfi n e d t o b e d or c h air m ore t h a n 
5 0 % of w a ki n g h o urs.  
Gra d e 4  
C o m pletel y dis a ble d; c a n n ot c arr y o n a n y s elf care ; t otall y c o nfi n e d t o 
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R ef ere n ce : O k e n M, Cre e c h R, T or m ey D, et al. T o xicit y a n d res p o nse crit eria of t h e East er n C o o perati ve 
O n c o l o g y Gr o u p. A m J Cli n O n c ol. 1 9 8 2; 5: 6 4 9 -6 5 5.  
 
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0 9 0 1 7 7 e 1 9 9 6f e 9 7 b\ Fi n al\ Fi n al O n: 1 9- S e p- 2 0 2 2 1 8: 1 8 ( G M T)
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Da c o miti ni b ( VI ZI M P R O® ) 
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a Wit h m ut uall y e x cl usi v e c ate g ories.  
 
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S u p erficial s pre a di n g t u m or i n c e ntral air w a ys  
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T u m or > 3 b ut ≤4 c m  
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T u m or > 5 b ut ≤7 c m or i n v a di n g c h est w all, p eric ar di u m, p hre nic 
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T 4  
T u m or > 7 c m or t u m or i n v a di n g: m e diasti n u m,  dia p hra g m, h e art, 
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0 9 0 1 7 7 e 1 9 9 6f e 9 7 b\ Fi n al\ Fi n al O n: 1 9- S e p- 2 0 2 2 1 8: 1 8 ( G M T)
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