Clinical trial: NCT02621398
Section: Confidentiality
Subsections: How Will Information About You Be Kept Priv*Te Or Confidential?

A1l efforrs rvill tre ruacle to keep .vour personal intbmmtiou irr yoru'rcsealch record coulidential,
[:ut total couiideutiality carurot be guaranteecl. Your personal intbnnation rua-v be given out if required b-v larv.  
Inlirrruation about vorr callcer ilud lreaturent r.vill be cr:llectetl fi-om your rrredic,al record for the study. The intbnuatiou will be rvith a snrd;* identilication nurntrer artd stored in a secured electronic file, The electrouic file is pris-rrvord protected and accessitrle onl-v to authorized srudy' persomel.  
If infor:nation frour tiris slutlv is published or presenterl at scierlific meetirrprs. yoru narne and hr addition, the study cloctor rnay stop you l:elieves it is in yoru'trest interesl. if y6u d.  
if ,vou stop. ,votl c'an decide rvhetlter or not to let the sftrdv doctol contirure to prorritle your uleclical urfbmration to the orqanization ruudng the shrcly. horvever. the FDA requirei that any iutbmration collected up to tlre point of 1,p1rr rvitlrdrawal carurot be removed froni tlre shrciv.  
Yr"rtt rlm1' also rvithch'alv Yolu' couseut for tlre use of clata aheatly collected about vou. trut vou rrmst cl,-'r this in tvritirrs to b{
Title: trlor"iIrg PD- I Blockade i|ith Penttxoliztumb info ('oucurrerrt Chenroracliation for Locall,v Ach.ancect Non- Small Cell Luns Cancer other pr.rsrrnal iutbnrratiot ivill nr.rt be rned.  
A desuiption of this clinical trial rvill lre availatrle on C]linicalTrials.gov. as required by U.S. law. This rvebsite rryill uot include inlbr:uation that cau iaerrr,$,y*r. At most. the website rvill i,cl,cle a slmulr'uy of the results. l'ou can search this website at auy tirne.
Clinical trial: NCT02621398
Section: Duration of Study Involvement
Subsections: While On Stud!' Treattneut:|Secontl Course Tre:Rtment:

Drrrilg the treatrnent period. yon will rleed the followiug exauiriations, tests- and prccedrues clescritrecl below. Some of these exarus. tests. artd procedrues ar"e par"t ol yotu regrrlar medical care.  
you will lrave tle foilowing c!:rre u,eekly while receiving chetnr:therapy arci radiatiou therapy, then ott Da-v- I of every ? I clay cycle rvhile receivilg pembrolizumab alone:
o you rvill be asked to reporl any s-vnrptorns ancl irealth probtrems yott ltave and any nerv meclicatiotrs yott have started.  
r yon will have a cr:mplete physical exatninatiou. rvith your physiciarr or physician's assistant. ilclutlilg measlu'eolent of yorr vital sigtts (breathing rate. blood pressue.  
temperafru"e, artd lteafi rate), height- alrd weight.  
r Evaluation of yotu^abiliti' to car^I] out dail--v activities' o You rvill have blood tests:
,.-: Approxisrately 2 teaspoons (10 url.) for routine testing, such as, a cotrrplete lrlood corurt, kidney. aud liver hrnction tests.  
,-) Approxiuratel-v I teaspoou (5 rnl) tbr thyruid fiutetiott tests evely 3 r'veeks while receivirtg Petubrolizruualt s On r/a"rx I cnd ! 5 o! evert, 2 I n cle. o;l' Penftroli;r*nab you lvill be asked to reporl any syurptoms arrd healtli problems you hnve and au-V new rnedications you have stat"ted, this may be done by a Phone call' o Trlttorl,sse.ssrrrents: You will have a CIT scan of the chest an\#or abdoruen every 9 rveeks while receiviug pernbroliztunatr to evaltute hor,v yoru caocer is r"esporrdirrg to the cancer.  
t Resertrcfi Labs;:I1 atlciition to trlood tests requiretl to monitr:r your health, other blood tests rvill be clole to see how'the irrumute system respouds to the different treatule[t courbilatiols ald closes. fur aclditioual2 teaspoons (10 rnl-) will be collected during rveeks l. 3. altl 6 of chemotherap-1, aud radiation artd druing Cycle t. 2 and -l of peurtrrr:lizurnab. These labs are being done fior study onl-v. They will be sent to a certtral iatroratory t'or testing a1d will not be a palt of yotr merlical record' After yon have completed stttdv treatureut:
Yoru doctor will stop sfttcly treaturenl il any of the followirrg occlll^:
r Yotu.tunor e11ows larger or you develop uew nunor$ ('tiisease progressiorr)
o You develop unacceptable sicle etl'ects r You lrecolre pregnant or are turwilling to use apprr:priate birth control tecluriques o TIre stl{y doctor detennines that it is not iu your best interest to continue the study trealmeut r You have corupleted shrdy treatmeut as plarured aud youl clisease has not worsened r Nen'intbnuatiorrbecoures available r The snrdy" is stoppeclbl'the I
o Yi-ru cltoose to str-r1"r strtdv treatrttettt
& the IRB or FDA
Title: Mor.ing PD-l Blockade rvirh Perrrbrrolizumab into Coucursrt Chernoradiation for Locall-v Ad'"'anced Nou-Srnall Cell Lrurg (lzurcer  
Alier all study freatruelrt hes stopped. yolr doctol will ask you to relum to the clinic for an end of treatment visit. rvhich will tre approxilmtely 30 days after l,otr lasi dose of study clnrg. You will renml tbr another cliuic visit approxilufltelr, I rveeks nfter yom last close of study drug. Tlte tbllowing assessurents will be doue at these visits:
o You rvill be asked to report any s,vrrrptorns ancl health problerrs yort have and any nerv uredicaliorts you have started.  
o You rvill lrave a cornplete physical esarnination. with youl physiciau or physiciau's assistant. iucluding uteasruenleut of yotu vital sigrrs (breathirrg rate, blood pressrue, temperaftue, and lreart rate), height" arrcl rveiglrt.  
o Evaluatiou of yoru ability to cany out daily activities.  
r [f you have any reruaining sicle et]bcts alter lreatmeut. you ura,v lmve blood tesls (at the
-30 day post-treatruert i,isit):
.:, Approxirnately 2 teaspoous (10 urLJ tbr rr:utiue testiug. such Rs. a coutplete blood count" kidrrey, and liver fiutction tests.
LqUerL--IJ!  
If you have arry r:ugr:iug sitle eflect at the tirue 1ou complete the sflrdy or yoru rioctor cliscontirures .v-ou fi'orn the stucly. the shrd-v doctor r.vill coutinue to fr:llow -vour couditiorr until the side etTect resolves or becornes stable.  
You rvill have imaging tests e\rerv l3 rveeks tbl the t-rrst year. then evet-v 16 rveeks fbr the second,vear aud then every 6 rnouths lbr years 3-5.  
If your disease worserls or'y'ou witlrrharv fi'oru the strdrv treatueut but uot fiour study fcrllow-up, the shrdy,statTrvill contact,vou approxiruatel-v everl l? r,veeks atter your last visit to check on yoru health stafti$. If they are rlot atrle to reach you. they rnay use a public infonuatiou sotuce
(like county recorris) to obtaiu iutomratiou about yoru'stuvival status orily. rvhich will be repoded as par"f of tlie dafa tbr the stud-v.

You may be eligible tbr up to one vear of acklitional perlbroliaunab (N'{K-347-5) therapv if the disease pro€uesses after: stopping pr.rubrolizuurab (I.{K-.1.175). Your sluely doclor r.vill cleteuttine if -vou rueet the snrdy criteria to be eligit.rle for the Second Course Treatutettt. If you ale eligible.  
you rvill restart treatnletlt at the dose and dose frequency received upr:n initial treatment rvith peurbrolizurnab ( It'lK-3475 ).  
Whnt nre the risks anrl/or discomforts ,vou might experience if you take part in this stutly?  
You ma-v have sicle etlbcts li'om the c{rrrgs or plocedrues used in this study. ald they rvill vary li'orn person {o pel'sou. Stud-v cloctt"rrs rvill carelirlly r.vatch evel}or}e taking part irr the stucly lbr any side eft'ects. Hr:rvever. the shrdy doctors and the study trrnders do uot latow all the side etfects that may happen, and unknorvr si<le et'fucts that could occril. The shrdy doctors uray give you medicine lo lrelp lesseu the side etlbcts. [n sorue c&ses. side eflbcts carr be seriotn. loug lasting. ard,'or ulay never go awa.y. There also is a rare rirk of death. You shr:uld tall to yr:ur snrcly doctor atrout anv side effects that .vou have wldle takiug part in the shrdy.  
If vou experierce allv severe side eftect.l'ou should:
r Seek professional nredical help iuuuediately Title: lloving PD-l Blocknde n'ith Sorall Cell Lrurs Crurcer Pentbrolizurtub into Concrureot Chelnoradiatiol for Locallv Ach'nncecl Nono ('all your shtdy doctor r If necessaly. go to the nearest eunrgenc;v roolll
Clinical trial: NCT02621398
Section: Participant's Rights
Subsections: Pir\Iission (Authorizntion) To T:S[ Or Share Health Infor]Iation That Idei{Tit Ies You T Or A Researc]H Stttdy

htlirnttation at:out vou and your health is pelsoual aud private. so this irrfonuation generallv caulot be usetl in research rvithout 1'om rvritteu pennissrou. The next ferv paragraphs tell,vou abottt hor'v researchers lvartt to use aud share voru health iufbnnatiou in this researclr snrdy. l'our inlbntration rvill onh' be tnerl as describecl here or as allor.vecl or required b1, law. Ask questions if 1''otr clrr not ttrtclerstattd ally parl of rhe lesearch or the trse of 1'orr health intbnrratir:n. If -v*ou sign this collsent fontt. ;,-ou aqree to let the resenrchers use your iutbnua(ion iu tlre le,searclt aud share it rvrth otlrers as clescribed belou,.  
Whrt is the purpose of the research rnrl horv nill my information be ured?  
You are being iuvited to tilke parl iu this rexearch stud-v rvhich is descritred at the begirurirrg of this {bnu. The purpose of collecting trncl usinq yoru' health infomration f'or this stucly is to help lesearchers arlswel'the questiorrs that are beiug askecl in the research.  
\\rhat infornration about nrr rvill be usetl?  
If 1.'ou choose to tre in this stuclv. the studv doctor rvill get yoru'persoual aud rrredical infbrrrratiou.  
This intbnuatiou nray include:
r All intbnnatiou iu a uredical recorcl r Results of ph-vsical exaurinatir:ns o lr,Iedical historl o ('tulent aud past rrredicatiorrs or therapies Title: l{oling PD-l Blockade u'ith Penrlxolizunrab into C]oncurerrr ('hernor.atiiatiol lbr Localh, Surall Cell Luus ('zuicer Or,I
r l.ab lests- oI'certain health intbnuation inrlicating or relatiug to a pafiieular coudition as rvell diaries and questionnaires r Records about strrdy meclication or r{mgs o Records of trlor:d tests r Results of clrest x-ray r Results of iuragilrg studies, includiug: MRI. cr aucl x-ray scaus e Inlbnuatiott atrout auy side etlbcts you urny experience wlule au stu6v lVho may u$e, sh*re or receive my informttion?  
The research leaur Infly rre or share your intbr:mation collected or created for this stg6y with the following people and inslitutioru:
.A,cllaucecl Nout 'ltI htstitttti.rtal Rer,ierv B.a.d (rRB). a sroup.f people rvlro revierv the lesear[filtrui]- to protect \,otr riqhts o Othctals of the r lVtembers of the coordiualors research ltlrr:ses and shrdv a a  
the courpaul' that supplies peurbroliaunab tbl rue in tliis stucly The LI.S. Foocland Dnrg Aclnrinisfrarion 6DA) o Depart'ierrt of Health a,d Htu,an Seruices (DHHS) agencies r OtIce of Huuutt Research Pt'otections (OHRP). involvecl in keeping research safe for people:
o Govemurental ageucies in other countries
by Federal l'per:nissiou. if Tltose persoos ot olsari.zations that receive yotu iufomiation may uot be reqtrirecl l privacy laws to protect it attd tnav share your iufonnatiou with others without voru penuitted bv the larvs sovemirrg thern.  
Will I be able to review mv research record while the reserrch is ongoing?  
No' We are llot able to sltare intbmtatiou ir the research recortls with -r-oir,uriil tlr" shldy is .ver.  
To ask ttlr thls inlbnrratiott. please contrct the Principal hrvestigator. tire persorr in charge of tSis research study^
Do I have to give ml,permission?  
No. You clo not hnve to pemrit rtse of yoru inlbnnatiou. But. if vou clo not give pemussiou. you catutot take part in tiris research study. (Saying uo does not stop you ti'om gettnig rueclical care ol.  
other benefit.ri vou are eligible for outside of tlris study.)
If I srt-vyes nou, can I change m.t'minrl and trke alvs]- my permission later?  
Yes. You ntav clmnge yotr ruind ancl not allorv the continueti ri.se of 3,oru' irribnnatiorr (a,ti to stop takiug p0rt in the sftrdy) at ftIl)' time. if y'ou take away pemussion. your iutbmration rvill 1o lc,,ger be trsed or sltared in the shrdy. [:ut rve rvill not be able ro take back infonnatiou that has alreily been ttsecl or sltalecl rvith othels. If 1,ou sflv )res uorv bul clrange vour nrincl later lbr use of vrrur Lrr 'Ir(rtL(r llrtrr L,trr(:lb. lt vt)tl:iilv \ies llt)w DllI CItAngg VOUI fu.Ln(l lAtef t0f'USe Ol 1r1r111. illbuuatiol in tlte research. 1'o,, rrr,rrt rvrite to the researcfuer aurl tell trirl6f vour.clecisi.r:  
  
  
How long lYill my permi$sion lest?  
There is no set date when your pelruission ivillend. Yotr health irrfcrnnation lnay be strdies tbr many Yeals.  
\Yhere cxn l'ou get more informstion?  
Ytru rnal,call the National C'arrcer Instihrte's Cancer luibnuatiort Service at:
\:oice; I -800-4-C'ANCER { l-800-422-6217)
You rnay alsr-r visit the NC:I Web site at http:,rcaucer.s,or" For NC'I's clinical trials intbruration. go to: http:ilcancer^gov:'clinicaltrialsi FoTNCI's qeneral infolnation about cancer. so lo htp-,,,,coflc 1gg:'ic-ongq{$lb-i If -r'ou do not [rar,'e access to R pelsoual computer" -you uray acces$ tltese websites and other irrftuuatiou at ir coruputer in the Rest'rurce arrcl Leamiue Ceuter ort tlte seconcl lloor of the
-
Clinical trial: NCT02621398
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Side Effects Cf Paclitsxel|Possible Side Effects Of Carboulatin|Possible Side F Ffects Of Luns Raclirtion|Side Effects Of Pemlrolizumab|Common|Llncommon|Rare|Reproductir.E Risks|Whst Will Hrppen If You Tre Injuretl During This Stutly?

Common, Some may be Serious (in 100 people receiving Pnclitaxel, more than 20 rnd up 100 may have):
o Arterrria whil:h luay cause tiledness. or rnay requile bloocl tratsfirsions r Infectiou, especinlly r.vhen white blood cell coturt is low o Diarrhea. llausea. voruiting r Sores in mouth which ruay cilu$e difficulty swallowing o Allergic reactiou r'vhich rlav cfluse rash. lorv blood prerisrre, wheezing. shofiness of breath. swelling of the tnce or tlur:at r Bnrising. bleeding o Par r Mrlscle weakrress o Nurul:ness. tirr*ling or paiu of the anus ancl legs o Hair loss Occ*sionnl, Some may be Serious (in 100 people receir.ing Paclitaxel, from 4 to 20 may hnve):
r Abnonnal heartbeat r Darrrage to tlie hurgs which may cause shoflness of lrreath r Blood clot rvhich olay cause swelling, pain. shorhress of breatlr Rare, and Serious (in 100 people receiving Paclitaxel, 3 or fewer may have):
r Hearl attack or heafi fhilure which rnay cau$e shortuess of breath. swelling of anlcles, aud tirectness r A tear or a hole iu tlte stonach which uuy cause belly pain or that may require surgely

Common, Somt mny be Serious (in 100 people receiving Carboplatin, more thtn 20 and up to 100 may have):
o Hair loss r Vomitirlg. nau$ea r Lfection. especially when l.vhite blood cell count is low I Aneuia rvhich rnay cause tireduess, or may reqni'e lrlor:d transfirsions o Bnrising. trleediug r Bell.v pail Occasional, Some may be Serious (in 100 people receiving Corboplatin, from 4 to 20 may have):
r Diauhea.cclnstipation o Numbness and tingliug iu lingers anel toes Tirle: l,lor.iug PD-l Blockade r.rith Perubmlizuuub into (loncurrsrt Chernotadiatiot for Locally Adlanced Non' Sumll Cell Luns Cancer o Allergic reaclion which ntav cal:s€ rash, low blood pre$sure. wheezing, sltortness of breath. slvelling of the face or tlut:at Rarc, nnd Srrious (in 100 p€ople rffsiying Carboplatin, J 0r fewer mfly h&ye):
r Cltanges in vision r Chauges iu taste o Damagre to organs rvhich lnay calr$e heariug aud trnlance problerns

Common, Some may be Serious (in I00 people receiving lung radiation treatment, more than 20 anrl up to 100 may have):
r Sr,velling ald redness. tanniugr. thickeuiug, rrurubness. or peeling of the skin in the area of radiation o Ditliculty anclr'or pain with srvnllorving o Hair loss in the treatuient area, rray be permaneut o Shorhress of trreallr r ('ciugh rvith or rvithout irrcleased phlegm productiorr o Tiredness r Diarrhea. rlausea Common, Sorne may be Serious (in I00 people receiving lung rntlintion treatme[t, more than 20 and up to 100 m*y have):
o furemia- rvhich ma,v require lrlood transtisiou r Infectiou. especially rvhen rvhite bloocl cell couut is loi.v o Bleeding. trnrising o Rib pain. increased risk of rib ti'actrrre Occrsional, Some may be Serious (in 100 people receiving rsdintion treatment, from 4 to 20 may hrve):
r Inflaurnmtion of the hurg that ruay cal$e difliculty breathiug and cau be lit'e-tlu'eatening o Nartourirrg of the lluoat which r*ay carue vorniting. difficulty srvallorving
. S!-arring in the lurrg r Lrurg collapse r Fluid arr:rurd lurgs o Bleedilg ti'orrr fhe luugs which ruay callse coughiug up blood o Feter r Nauorving of the esophagus r Pain iu chest rvall

Peurlrrolizurnab rvhiclt is apprtrved in the t,IS].,{ orrrl sorne other courh'ies is available try prescriptrort to treat several ditl'ereut cancers. but uray not be approved to treat -vour rlpe of cancer.  
Tirle: Mnving PD-l Blockade rvith Peurbralizuurnb info Concrwent Chernotadiatiorr for Locally Aclvancecl Non-Surall Cell Luus Cencer Overall. as of 03-N.{ar-3018. approxinratel)- 25-5}9 patients lrave been lreated with peurbrolizurlab in clinical studies.  
Peml:rc,lizumab rvorks by helpirrg lrour irrururne sy*tert to fig]rt yotr caucer.  
However. petnbroliaunab catl also cause yorr inunlme $y$tem (o attack norrnal orgiui$ al]d tissues iu your body ald can affbct the way they lvr:rk. wlilch can residf iu side effects. These side effects uray be serious (i.e.. causi.ng hospitalization or be life tlu'ealening) anri tnay result iu death. and/or rnay occur ttler yotl stop taking perubroliauuab.

Out of 100 peopte who receiye pembrolizunrab, at leart 5 but less than 20 people msy h$ve the following:
o Joirrt pain o Fever r Back pain o Rash r Pain in yoru'bell-v o Loss of skin color r Not enough thl.roid honuone so )-orr uray fs*1tired" gain weight. feel cold. have iul}equent or hartl stoolslow ler,el of salt in the trlood that uray cause you to feel tired.  
conilsed- have a heaclache. mtxcle cramps ancl,r:r feel sick to your stomach

Out of 100 peopte who receive pembrolizumab, *t least I but less than 5 people may h*ve the following:
r Inflanunation ofthe lungs: so you uray feel shon ofbleath and cough. r Too nruch thyroid lromroue so you ura-v tbel atrxious. aug]. have trottble sleeping. tbel rveak. tremtrle. srveat. tbel tired. have loose ancl rvatety stools o Iltirsiou reaction. r.r,here ;,*ou llmy tbel dizzy or faint. flushed. get a rash, have a fever, feel short of breath at the tirue of receiving yoru'inftlsion {NJ or just aftel" or pain at the site of intirsion r Inflauuuation of the bowelsigut . r.vhich ruay cause severe pain iu your belly with loose or waterl, stools aud black. tau-v. sticky stools or stools rvith blood or filucus o Inflauunatiou of tlle skin so you runy have peelirrg of the $kill. itchiness alldror-skin redtless. Tlre skig j1fl61nrnalion (i.e. peeliilg, itchirrg. and redness) could also be rvictespreacl tlu'oughout yoru body. N,lore ser.ere skin reactiorx may involve the irrsicle of
-vour rirogth. the siufhce of y'opl elre aud geuital areas. andror ttta.v catue tlte top la-ver of voru'skiu to peel flour all over volu'bo<ly which can catrse sevel'e irfectiofl.

Out of 100 people u,ho receive pembrolizumlb, less than I person may have the following:
r hrtlanunation of the ltela e$ that rna.v catrse pirin. u'ea}'Lless or tilgling -votu hands and feet. alcl uray spread to yotr legs. ar:ns and ul.rper bodv leacling to severe rntmcle rveakrtess arrcl possitilr: terttporarv para lysis.  
r kitlanunation of the uruscles $o you nray t'eel rveak or have pain in vottt tuttscles e hrtlauunatiou of tbe pnncreas (a glaud in yoru abdr:ruen that coutrols sllgar levels) $o you ura-v have severe upper al:t"lominal pain that luay move to yotu back. feel sick to yoru' str:ruach. and vomitiug that gets worse when you eat o Inflarurlatiqu of tfie eye so you may har,e eye redrtess blurrecl visiorr. serrsitivity to light.  
have eye paiu. see floatels ot hRve lteaclaches o Inflalunatiorr of the liver that ma1' ntake you feel sick tr: your stonlach and votnit- feel like not eatirg. feel tirecl. have a ruild f'ever, have a paur in the rig.ht side -votu belly, yellorv eves ancl skin. and dark trt:itte o ldlilrrulatiou ol the pituitary glancl (a gland in the head). which rray carme you to t'eel sick to !,clrlr storrrach or have headaches chattges iIr -votr behavior. double visiou' few tt'r no rnenstnral cycles. rveakuess. vomiting artcl clizzirtess or thintirrg.  
o Actreual glalcls (glands on top of the kittae-vs) that rnay not rnake enough honnorre rvhiclt coul<l calse rirediress. rveight l6ss. msscle weakrtess. feeliug failt. ioirrt. tnuscle aDd belly aches. uausea. r,omilirrg. tliantea. fever. salt crar,ittg. and soutetirues darkenilg of the skin like a stultitrl.  
o Tlpe I Diabetes. a colditiorr that can cause too ntnch sugar in,vr:tu bk:oti. feeling tfiirstier than psrml. ti'equeut rrinatiou and rveight loss. Yott are likely- to need regtilar insulirr shots.  
r Intlauunatiort r-rf tlre kidney so you swelling ancl lorv back pain may pass less urine or have cloudy or blor:dy ruine.  
r Too uttrch strgar in,vour blood {diabetes). so vou ulay feel thirs$. and lla.v tteed regttlar itsulin shots.  
o lutlauulrafiou ol tlre ruiclclle la-ver of -voru lteart ivall that may cnlrse -Yotu lteatl to ltave clitficllt-v pumping bloorl tlu'oughout -vour bocly. rvhich catr cause chest pairr, sholtness of breat6 arrcl srvellilg 6f the legs. You may experience a fast or inegttlar hearlbeat that may catrse clizziless or"faiuting. Iuflanunatiott of the thSroid glnnd, ao organ lhat urakes aud steles thyroicl honrrones. This corr<iition may learl to change ht -votr heafi rate. blood presistue. bocly teurpelatrue. and tire rate at rryhich tbocl is cclnvetted iuto euergy-r A condition that rna-v make 1'ou feel rveak and tiled ancl might have drooping of the e-velids. bftured or clogl:le visiou. elit]icult-v srvall:rvirtg. sluned speech. weakness in 1'oru arrns and legs. or diffictrh "* l:reathing.  
o Tlre tbpuation of srnall chsters of iuumure cells (called E[auttlouras) in parts of yoru' bod-v such as yr)ur lyrlrph ttotles. e-ves. skirr. or ltutils Title: \lol'ing PD-l Bk:cknde rr'ith Penrbroliaurub info ('oucurent {'heuroracliatiol for Locally Acltnncetl Nol-
I I the trraiu witlt cortlitsion ancl t-ever. Thir; utav alsr.r mmle:__?GAtieutation. rrlernorl,prCItllelns, seizures (tits). chauges iri personaliry and treltavior. clifliculty speakmg- lveakrle$s or lo,t$ of ruovemmit in some parls of yatu body.  
and loss of corrsciornness Aclclitir:ually. since perubrolizurnab rvas applovecl in Septeurber 101.1. the followiug side el'lbcls have been repi:rted by people receiviug pernbrolizuuratr. These sitle ettects rvere voltuttarily reporled fi'oui a group of people of urknoq,n size. It is notpossilrle tr: estiurate the ti'equency of this side et'fect:
o Inflauuuatiou of the joints rvhich rnay iuclude joint pain. stiffness audror srvelling If you have hnd au allogeueic steru cell trausplant (a procedure in which a perscln receil'es blor:cl-t'crruing stem cells t}orn a clonor). \:ou nrav experieuce grrati versrs host disease (GvHD).  
rvhich maf iuclude dianllea. skin rashes, aud liver daurage. after receiving pembrolizumab.  
Sometirnes this cturdition can lead to cleath.  
If ,vou have had a solid organ transplaut {for example. if .vou have rcceived a kiclney or heafi transplant), you rua--v experience rejection of the transplanted organ. Yr:ur doctor rvill rnonitol you and should tell you what sigus anil slrnptonls you should report deperrdiug on the t1,pe of orEIarI
trausplaut that you have harl.  
Patients treated r.vith pernbrolizuurab BEFORI going on to receive an allogeneic stem cell transplant (a prr-rcedue it which a persou receives trlood-fomring stem cells tlont n donor).  
should iufonu their transplant phy'sicians that they have received pembrolizuurab in the past. hr patients with anv heuratok:gic ualignancy (cancers of the blood like Hodgkin llrrrplu:rua.  
umltiple rnyeloma): there is a po(eiltial fc-rr an increased risk of severe courplications fi:llorving alk:geneic stent cell transplant in patients rvho previousl-v received peubrolizrunab BEFORE an allogeneic steur cell transplant.  
Repr:rts of clottirrg of trlood rvithin the liver aud severe grali versus host disease (rvhich cau iuclucle skin. lir,er and gastrointestinal syruptoms). irrclueiiug death, have beeu received for patients who received perrrbroliauuab BEFORE au allogeueic steru cell transplaut.  
Palieuts rvith ruultiple nryeloma rvho were treated with pembrolizumab iu conlbination rvith eitlter porualidornide or lenalielornicie (rhlgs lelatecl to ihalidouricle rvhich attect the body's iuurruue svsteur) ancl dexanrethasone (a steroid) had an increasecl numbel of serious side etl'ects and deaths as comparecl to patients rvho received oul.v clexarnethasone and either pouralidornide or lennlidouride.

Yr:tt sltoulcl ur:t becotne pregnant or tather a traby rvhile on this shrdy because the dnrgs nnd racliatron treatuellt in this studY cau af'tect an urrtrorl trab-v. Woruen who are able to have children will have n pr^egnarlcy tesl before beginling trealtilent. Wonren should not breastfeed a babv while on this shrdy. It is iurportant )'ou rurclerstard that ).orl need to use birlh coutrol for as Title: \.loting PD- I Blockade u'itit Pentbrolizuumb inlo Concruteut ('herrroradiation for Locallv Ach'ancecl Noltreaturent on this shrclv and for 130 da-vs after cotnpletion of all treatment to pl'event preglarcy or fatherirg a child. Check with yorr stud,v doctor about whal kuxlof bn'th cortrol lrethod$ to use. Some methocls uright uol be approved fcrr use in this snldy.  
The trenturent in the study ma,v urake you unable to have childreu in the firtu'e. Woureu of childbearing ase cau ask tlreir doctor l'crr infonrratir:u al:out pre-treatrnenf or posl-treatment reprochrctive r:r lbrtility options plior tr: agreeiug to participate in the stud-v*.  
Possible Risks Related tr: Reprr:tluctir.e healtlisexual activitv Reseatclters har:e not snrdied the eft'ect of the snrd1, dnrg. penrbrolizurnab, on human sper:n and eggs. Thev also do not knor.v the effects on the developing fetus using the study dnrg dtuurg pre$lancy autl the risk of birth defbcts trom use of perubrolizutrab. 'I}erefiore, troth rrren aud woulen shoulcl not attenlpt pregnancy arrd rvomen shoukl not tre pregnant or breast-t'eeding rvhile takurg pail iu thi.s studv and tbr at least 120 days atler your last close of the strrcl-v dnrg peubrolizumatr.  
if sexually active. lroth rueu and rvouren slrould use al] effective ure{rod of birth coulrol rvhile taking the study clnrg. Barrier contrficeptives (coudolus or cliaplu'agm) r,vith spermicide.  
intrautet'ine devices iIUDs]. ltonuonal contrnceplir.es, ornl conhaceptive pills, surgical sterilization. aud cornplete abstiuetce are examples of eftbctive urethods. Onl.v-.- methods that use cottdorns provide reasonable,'tnre protection against sexually tranuuitted diseases. if -vou or yout' pulner becotne pregrtaut r.l,hile takins the stlrclv dnrg. yro11rnust tell ).our shrd)'ntu'se/doctor irnrnediately. You ruav have to stop the slldv ilmg. Yorr doctor i.vill discuss r-rther treatnreut optiorls rvith -von if -vr"lr stop the study.'dnrg.  
A rvotnan should not lrreast-feed a baby rvirile ur this shrdy lrecause pembrolizuurab uray erter tlte Lrreast rnilk and possibly hann the clrild.  
If t,ott are a tvoman capable of benrirrg childlen. you rvill have a pre€$arcy test before you can participate in this snrdy. If at aul,time druing the shrdy or rvithin I10 days atler yoru'last close of the study dnrg penrtrrolizruuab vou suspect that 5'ou have lrecon]e prelurant. please notify the shrd-v doctor i rruuedia tell-.  
tr{ale participanls should inulediately intbmr the stucl-v doctor if your partuer becoures pregnlant chu'ing the snrdy. rvithin 120 da,vs after your last dose of tlre snrdy dnrg penbroliarmatr.  
Are there any benefits for you if you choose to take pnrt in this research stutly?  
Taking part in tlis snrcly luay or rnlry not umke inrprove yotu health better ol allorv you to live louger. Ihe irrfbrrrralion fu'oru this stucly rvill lrelp cloctors lear:r nrore about peurbrolizuruab as a treatulent for NSC'LC'. This inibnuatiou cr:ulcl lrelp othel people who have a sirnilar rnedical conditiorr in the firture.  
What are vour alternntives if you tlon't want to tnke part in this stucly?  
You do not have to ti-lke parl iu tltis research snrcly. If y'ur decide nol lo take part in lhis study.  
you have other choices. Instead of treurg in this strrdy" you cau:
o Cltoose to have tlte tsual approach to treatureut described above without being in a strrdy r Take part in auother shrd-v o Get t-outfort care. also callecl palliative care. This tlpe of care helps reduce pain.  
tileclness. appetile problerns. ancl ollrer prolrlerns t:aused [:-v.. lire c{ulcer. It does ru:t tleat  
I
the cancer directll'. bul instead tries to inrprove hor.v you teel. Comfi:rt care tr"ies to keep you as active ancl coudbrtatrle as possible.  
Please talk to the study doctor alrout yorlr choices before you decide if yc,u will take pzut iu this shltl,v.  
How will -vou know if neu' informntion is learned that may affect w'hether you sre r*'illing to stay in this research study?  
Duriug the study. yoru stud_v doctor will tell you about new irrtbnnation or changes in the shrdy that ruay at't'ect ,vour health or yom' rvillingness to continue in the study. W-hen intbnnecl of thrs uew iufcrmratiou. if -r,-ou agr ee to crlntiuue in the sftrdy. your doc(or will ask yolr to sigm att updated Intbnned Consenl Fonn.  
Will there be any cost to -vou to take part in this stutly?  
You rvill have tests and pror".edtues that are pad r:f your regular medical care {ur:t parr of the research). incltrdirrg the treatruent with cheurotlierap.v ald radiation therap;*. Yott or yotu irrsu'ance compauy or: thild pat'ry'provider rvill tre responsihle far these cosis. inchrdiug copaliments aucl dednctibles.  
The snrdl'rvill provide the dnrg perubrolizuurab at uo charge to you rvhile you take part in tliis stud-v. The snrdy does not pay lor the cost of gettiug the stud-v dnrg ready and giviug it to you infraveuously (iu a veiu). You or -voru insuraur:e compailv rvill pay tbr this procedue.  
Yoru'doclor and yoru other health care providers will bill the cosf of yorr regular rneclical care tr:
you or tCI yolu'health insurance cornparrv in the usrml way. Ht"iwever. some lrealth insruance plans rvill uot pay the costs tbr people takirg part in strdies. Clieck r.vith yow health plan or insruance compan!'to find out rvhat the.v ivill pay for. Taking parl irr this .study luay or may not cost youl iusur.ance cornparlv ruore lhan the cosl of getting rcgular treatmerlt. If yoru ittsruance does uot pa-y, you will tre responsible tbr the charges of your regular ureclical care. Beftrre you decide to palticipate ilr the stucly. you should check with yr:ur health insurance company to find out exactly r.vhat it rvill pa,v for.  
If .vou have an1 questious aiiout instuallce covemge, including arlv out of 1:ocket espeuses -yolr nriglrt incur. or lvlrich labolatory or lacilities )iou are allor.vet{ to have tests at. a tinarrcial cormselor lvill be macle ar.ailatrle to .vou upon request.  
Will you be paitl to take p:rrt in this stutl"r?  
You rvill uot receir,e auy payrnent for,voru'participatiou il this stud1,.

Subjects iu tlis shrdl' rvill tre exposed to certain risks of personal injuly in addition to tbose associatecl rvith standarcl fou[s of treatnieut. rvhich rvere'discussetl in the Risk ancl Discor,forls sec(iott of this conselt tbmr. In ad<litiou. it is possible that chu'iuq the course of this stu4y. new adverse etlbcts of paclitaxel, carboplatin. peruLroliauuab and raiiation therapy that resylt i1 pu'sottal inltrry tuav be discovered. The Lluversity will nmke appropriate r.efeirals for gredical attd;'or deiltal treatulent ttrr subjects ,rvhr: sustain persoual irrjuries or ilhresses as a clfueef cousequence of participation irr tlte tesearch. Ttre subject's liealth iusurauce carier or other thircl- partl' payer rvill be billed tbr the cost of this treatnreut: provicled that the Uliversiry,. shall u.t sutrurit to federalh' fi"urdecl proglanrs. e.g.. \..Ietiicare. Ir,.{eclicaid or cHA1r.{pus, fo; reitntrrusetlrent tirst if stlbutissitrn lo such prr)Srall)s is prohibiteclby 121y. Ir{o 1i*arrcial colllpensatir:n ivill lre prc'rvided b1' the L]nir.ersitv ancl no other ry*pe of a.ssistance i,s available li'oru the Uuir.ersitv.  
Yotr.ate- lol gil'ing lrp allv of votr legal rights by signing this intonnecl corrsent fong or by takilg parl in this resealch stud,v.
Clinical trial: NCT02621398
Section: Procedures
Subsections: What Wiii You Be Asked To Do If You Take Part In This Research Study? Belbre You Begir Snrdy Trentueut:|Stiidy Triati{Ent

You will har,e some exaus. tests aud proceclures to fintl out if .v-otr can take parl in this shrdy.  
Ir{ost qf the exams. tests, antl procedrres you will ltave are part of tlte txttal apprcach for your cancer. Horvever. yorr doctor"rvill do solrle exlra teslirrg as parl of tlte stucl;*. The testirrg that 1"ou rvill ueed to hnve if you take pzut in this stud-v is tiiscussecl below. If sorue of these have been done recentl;* they ma,v not need to tre repentecl. this will be up (o the shrdy doctor.  
r Yoru age and racer'etluticitl, rvill be recr:rded.  
o You rvill be asked abou{ 1,'6llv trredical history and auv taking. both prescriptiorr Rutl over tlte counter.  
ruredicatious \'oll ate ctrtrenily Title: lr{or.ilg pD-l Blockade r.r-itlr Perulx'olizruuab into Concru::ent Chernoradiatiorl for Locally Advnnced Nort-Srrmll Cell Lttrts Cnrtcet' I I a cornplele physical eliaulillatioll. wiill yolu physician or ph-vsician's
;ffiffffiiirding ureasruement of yoru'r'ital sigrrs (breathing rate. blood presstu'e.  
tenperafiue. antl ltear"t rate). height" and weight.  
o Erraluation of yoru abiliry,to canY or( daily activities. r The lollorving blood samples tvill be collectetl within 14 days of registration:
,:) Approxirrrately ? teaspoous ( l0 url-) for routine testing, sttclt as. a complete blood corurt. kidney aud liver firuction tests to ensure that it is safe to adruinister any of the clnrgs irrehrded irt tliis study
,r' Approxintatell'' I teaspor:n (5 url-) for bloo<l clottirrg tests
,: Approximately I teaspool (5 rnl-) tbr thrrroid turtction testing r If you &re a rvoutan rvho cotilcl l:ecorne pregnant (evel if you had a tubal ligation). yotrr dgctor rvill perfonu a blood or wine pregllancy test. If you at'e pregnant. yotl carutot participate irr this shrdy.  
r Pulutouar-v Function Tests, to see horv rvell tlte ltugs rvork o 1na[ring tests typicall-v perfrrnued firl caucer patients. irtt"'lucling imaging of chest.  
abdoruett aud brain. Scaus rvill inclucle:
ir C'omputect tornography (C'T), a scan thnt trses x-r'ays to look at one part of your trocl-v-, tt ma,v Lre <lone r,vith or tvithont contrast. Contrasl [rearts that d,*-e is injected intq voru rreil to increase t[e differeuces behveen nounal and abnonnal tissue.  
.:! N{agnetic resonance irnaging (N{RI), inraging tltal trses n stl'oll!{ uragnetic field to look at oue part of 1'otrr trod.v.  
i-1 Positron ernissiou tomogram (PET). uses cornptlterized iutages to look at the activit).- of tuuror cells in yoru entire body and that requires injectiou of a special marlier irrto -vour vein. such as slrgal (glucose) conibined rvith a lorv-dose radioacrive sutrstance (a tracer). A camera records tlte tracer's signal as it travel tlu'ough yoru trr:tlY.  
r You rvill be asked to provide a saruple r:f yotr nttrror ftrr researclr from a recell stu'gery or triopsy (rvithin I rveeks). If your ftnnor s1:eciruett is greater than 8 rveeks old, you ruay still be able to take part in the shrdy if the hunor is availal:le. the spousor gives penrissiou and you are r.villir:g to ruldergo t fiue tteedle aspit'atiott (a trethod to remove a piece of lturg tissue for eratuination).  
Your cl6ctor rvill send the ftunol sample to a central latr fnr testurg of certain proteins and biourarkers (iuclicators of nonnal Lliological or disease processesJ that ma-v lre involved in PD-l activatiqrn or to urderstaud the nafirre of your disease. These latroratorl tests are perv a11d rurder cleveloprrrent. Alrv reruainirtg slides atler the testirrg is cottrpleted will be deshoyed.  
If you clo uot ureet the eligibilitv requirerrrents. you carurol take part in this study. The snrdy doctor rvill inlor:n -vou of crther optiotts tltat are available tr: Yotr.

If t[e tests. exarts. procettues show that you can be in the stud;-, you rvill be registeletl' All shrcly paiticipants rvill receive cheruotherapy (paclitaxel and car't:oplatin). radiation therapy and 1:erubrolizuutab.  
Title: \{ovipg PD- 1 Blockade tvitli Penrbrolizuurab i:rfo ('oncru::errt Cheinoradiatir:n for Locally Adt ancecl Non' Srnall Cell Luns. C'  
. &idl4lrge-XlgI3p]:; You rvill receive radiatiort therapv daily (lr'trorrda-v * Friday) for 6 lveeks. Each treaturent uray take up to l5-30 ruinutes deperrdirrg on the teclurique trsed.  
r C'heurotherapy: You rvill $tart chemotheLapy the same day as you stall radiation therapy antl ttren receir.e cheruotherapy once a rveek. Yotr will receive chernotlterapy betbre yotu radiatiou tleatrnent ott days yolt ate scheduled to rcceive bcrtlt.  
r Pembrolizuumb: Dependirrg ou rvhat part of the sttrdy you enter. lhe dose artd time rvhen you stafi treatrenf lvith perut:rolizrunab will vary. The tiruiug of this uredicine coultl tre atler ol dtuirrg the rndiarion tlterapy.  
Rrdirtion Themnv:
Yuu study doctc'rr will clecide rvhat type of radialion therapy I'ou will receive.  
r -l-Diureusioual contbnnal radiatiorr therapy or intensitv urochrlafed racliation therapy
(fl\,IRT) is a lbnn of radiatir:n in which a nuurber of x-ray beaux are used to shape the radiatiou to the cancer arrd is desigrred io arroid iurpotlaut nonrral parls of yr:tu body.  
o Inmge guided ladiation therap,r- (IGRT) radiation part of the mtttine radiation treatment that helps to aligrr the radiaticln accrralely 1o the truuor. Sruall adjustmertts itt yotu radiatiorr treatment are ruacle each treatment day basecl on x-ray iurages taken riglit before each day's trea(ment tc! erlslu'e that yoru racliation tl'eatment is given as accut'Rtel-v as possible.  
r Proron Beau Therap,v (PBT) is auother l1'pe of exterrral radiation treatureul and is precise like Itr'{RT. but uses protor beatrs iustead of x-ray beauts to direct rhe racliatiorr.
Before you begin radiation therapy. 1'or"r rvill have itnagirrg of the chest irr otder to design -votu radiatiou treatruent. Doctors will use iutbrruation gathered ti'otn these scans to plan the best rvay to deliver racliatir:n to your hunor.
Clinical trial: NCT02621398
Section: Purpose of Research
Subsections: \Yhy Have You Been Nsked To Tnke Part In This Stutly?

You are beiug asked to take palt in this study becarme you have irroperable ttotl-surall cell hurg carlcer (NS('LC:). People rvho courplete their treatrnerrt ate ttstrally obsewed ott a regttlar basis tbl prog.ressir:n of lheir disease.  
l\"ho nrn.v take plrt in this stud.v? And n'ho may not?  
You rua-y take part in this stuclf if -vou are l8 .vears of age or €reatel r.vith inoperable nott-surall cell hurg carcer. Additionall)'. ).'ou utay take part in fhis shld,v if:
o Your treaturent plan inchrdes cltentotlterapl atrd radiatiorr o You have ftuui:r arrailable flonr a receilt surgery/ or lriopsl' r You have reacl ancl signecl this Intbnnecl Clonsent Fr:rm  
You nu1'uot take part in this sttrd-v it:
r You have cancer that has spread outsitle tlie ltrngs to other partx of the bod-v o You are uuatrle to keep 1'ortr cloctot''s appoitttrnertts r You ale prepnlallt or breast tbecling
Horv long will the studv t*ke and horv m*ny subjects rvill participate?  
You rvill receive cheruotherapv ald radiation ttrerapy for 6 rveeks. Stutly treatmertt r.vith pernbrolizurnab will contiutre t-ol one yeiu. as loug as yotu ttunor is respontlirrg artd yott at'e nol experiencirrg se\iere side etlects. After you hat e stopped ret'eir,ittg treiltment ol shtclY. rve will contiuue to fcrllou,up rvith vou for the test of }'oru'life.  
A total ol approxiuiately 30 triatients rvill take rt in this stt You r.vill be oue of approsiurately l0 patietrts eru'olled at the
Clinical trial: NCT02621398
Section: Voluntary Participation
Subsections: Agree N,If ..*T To Participate|R.Or No\.Itglish Speaking St]Bj[C'Ts: Signrture Of Rerrler/Translntor If The Subject Does Not Reld English Well:|Sign:Rture Of Inr,Estig*Tor/Individual Obtnining Consent:

I have read this eutile tonu. r:r it has been read to me. aud I
treen tliscussed. All of rny questious about this fcrrrn or this believe that I turderstancl rvltat has snrcly hnve beeu arxr.vered.  
I agree to take part il this snrdy.  
Sutrject Narure Subject Signanu'e f)ate:

The persi:u rvho ltas signed atrt'rvr' well. Yc'u read Enslish rvell and are tluent in cloes uot read Euglish
{notrc of tlrc langmge)- a language that the subject (his,'her Farerrt(s)1legal guarrliau) tuderstarrd.s tvell. You rurderstaucl the cotrtent of this couseut fbnn arrd you have translated tbr the sulrject (his,{rer parenl(s)/legal guardian) the entile content of this forur. To the liest of.votu'lurorvledge. the subject
(hisiher parerrt(s)rlegal guarclinu) uuderstands the colrtent rit this tbun and lras hatl arl opporturlily to ask questions regalcling the couseut fcrnn ancl tlre snrd-v. aud these qttestions hnve treen ausr'verecl
(lrisrher parer]t{sJ/'legal grmrdian).  
| Reader Trarmlator^ Narue Reader,'Trauslator Si snahre :   | Date:         |
|-----------------------------------------------------------|---------------|
| \\'itress Naure: Witness Siguattrre.                      | I)ate         |
| C'onsent r'08r'39rl{) 1 I                                 | Page 17 ol 18 |  
Title: Iloling PD-l Blockade *'ith Penrtx'olizuumb info Colcurerrt Chernoradiatiou for Locallv Adr.ancecl Norr-

To the best of vour abilih'. volt ha\ie explnined and discrrs$ed the tullcoufent$ of the shuiy including all of the ittlouuatiorr cortaiuecl in this corlsent lbnn. All questions of the researclr sttt'f ect and those of his,i'her pal'erlt or legal suardian have lreeu accuratelv ansrverecl.  
hrvestigator','PeLson Obtainils Conseut :  
Signahue: Date:
Clinical trial: NCT02621398
Section: Withdrawal from Study
Subsections: What Will Happen If You Do Not Wish To Take Pmt In The Stutly Or If You Ltter Decide Not To Stny In The Stutly?

You cal decide to stop at auy tiure. If you tlecricle ta stop for auy {easoll- you prst let t5e shldy cloctor Inrorv as sooll as possible so voll can stop safely.  
If 1'ou clo uot lt:attt to euter tlte shrrll, or clecide to stop participatirrg. -your relatio,ship with the srudy statTrvill not chanse. and t ou tnav tkr scr rvithoui penalty anr{ without loss r:f lrelefits to wlrich vou are other-lvise entirled.  
It is important to tell the stud-v doctor if you are thiukine about stopping so alv risks fi.or, tle shtdv caD be evaluated by yotu'doctor. Another reason io tetl -oo,r'riu,ly doctor tlat yqu are thir*hg about stoppiilg is to discttss rvltat folkxv-up care ancl testilg cquld tre nrost helpftll fcrr you.  
ti'om taking part il this snrd-v at ally tirne if he,/slre rrot follon,the sluclv mles: or if the study is stoppecl.  
  
Title: \lovirrg PD-1 Blockade r.r'ith PErrrl:rolizuurab into Coucrurent Chernoradiatiorr fal Locally Advanced Non-Suull Cell Lurrg Clalcer At any tirne. the study doctcu'cilrl take you out r:f thir shdy because it rvould not be ir you'best interest to stay irr it. er.en if y,:u are willing to stay in the shrdy.  
If you decide to r.vithdrarv flour tlte snrdy for an)r rea:iorl. voll nray be asked to rehrnr for at least oue additional visit for sal'ery.rea$ous.  
llrho can -vou call if you hnve any quertions?  
If you har,e au)'questions abr:ut toking part iu this stud,v or if you feel you may ha\re sutlered a e: (  
  
  
If you have arn'questious about yorr riglrts as a re$earch sutrject" you c*n call IRB Director What &re vour rights if you decide to take part in this research study?  
You ltave the riglx tr: ask questious about auy parl of the shrdy al auy time. You shtiuld uot signr this fcrnn unless you ltave had a charrce to ask questious nnd liave been given ailswers to all of your tluestions.