Phase 3 Study of Pembrolizumab with Concurrent Chemoradiation Therapy Followed by Pembrolizumab with or without Olaparib compared to Concurrent Chemoradiation Therapy Followed by Durvalumab in Stage III NSCLC
- Conditions
- nresectable, locally advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003237-41-IT
- Lead Sponsor
- MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 870
1Has pathological(histologicalORcytological)confirmed diagnosis ofNSCLC
2Has StageIIIA,IIIB,orIIIC NSCLCbyAmericanJointCommitteeOnCancerV.8
3Is unable to undergo surgery with curat intent for StageIII NSCLC as document by a multidiscipl tum board or by the treat physician in consult with a thorac surgeon
4Has no evid of metast disease,indicat StageIV NSCLC,in whole-body fluorodeoxyglucose(FDG)-PETorFDG-PET/CT andCTorMRIscans of diagn quality of chest,abdomen,pelvisAndBrain
5Has measurab disease AsDefinedByRECIST1.1,with at least1lesion being appropr for select as aTargetLesion,as determ by local site investig/radiol rev
6Has not receiv prior treatm(chemother,targeted ther or radiother)for their StageIII NSCLC
7Has provided tum tissue sample(tissue biopsy[core,incisional,orExcisional]).FFPE blocks are prefer to slides.Newly obt tumor samp is highly prefer over archiv tissue and should be obt prior to the thorac imaging at screen
8Has a perform status of0or1on theECOG PerformStatus assessed within7ds prior to the1st administr of stud interv
9Has a lifeExpectOfAtLeast6months
10Has adequatePFTdefined as aFEV1>50%of predicted normal vol and the carbon monox lung diffusing capacity(DLCO)>40%of predicted normal value.Partic for whomDLCOmeasur are not avail will be deemed to have adeq oxygen transfer ifPulseOximetry(O2 satur)is determin to be=90%onRoomAir
11Has adeq organ function;all screen lab tests should be perform within10ds prior to initiat of stu interv
12Particip are at least18years of age on the day of signing the inform cons
13Male partic are eligib to particip if they agree toTheFollowing dur the interv per and for atLeast180ds after theLastDose of stu interv:
-Refrain from donat sperm
PLUSeither:
-Be absti from heterosex interc as their prefer and usual lifestyle(abst on a long term and persistent basis)andAgreeToRemain abst
OR
-MustAgreeToUse contracept as detail below:
Agree to use aMale condom plus partner use of an addi contrac method when having penile-vaginal intercour with aWOCBPwho is notCurrently pregn
-Contracept use by men should be consist with local regul regard the methods of contracep for those particip in clin stud.If the contracept requirem in the local label for any of the stu interv is +stringent than the requirem above,the local label requirem are to be followed
14A female particip is eligible to particip if she is not pregn or breastfeeding,and atLeast1of theFollow condit applies:
-Is not aWOCBP
OR
-Is aWOCBPand using a contracep method that is highly effect(failure rate of<1%per year)with low user depend,or be abst from heterosex interc as their prefer andUsual lifestyle(abst on aLong term and persist basis),dur the interv per and for at least180days after theLastDose of stu interv and agrees not to donate eggs(ova, oocytes)to others or freeze/store for her own use for the purpose of reproduct dur this per.The investig should evaluate the potent for contracep method fail(ie,noncompliance,recently initiated)in relation to the1st dose of stu interv
-AWOCBPmust have a - highly sensitive pregn test([urineOrSerum]as requir by local regul)within24h for urine or within72h for serum before the1st dose of stu interv
-If a urine test cannot be confirmed as - (eg,an ambiguous result),a serum pregn test is required.In such cases,the particip must be exclud from particip if the serum pregn result is+
-The investig is respons for rev of medical hist,mestrua hist,and recent sexual activ to decrease the risk for incl of aWom
1HasSCLCor a mixed tumor with pres of small cell elem
2Has MDS/AMLor has features suggestive ofMDS/AML
3Has had docum weight loss>10%(from baseline)in the preceding3months
4Is likely to have a radiation treatm plan that will encomp a vol of whole lung(tot lungV20-GTV)receiv>20Gy in tot(V20)of + than34%of lung vol
5Has receiv prior radiother to the thorax,incl radiother to the esoph,mediast,or for breast canc
6Has receiv prior ther with an anti-PD-1,anti-PD-L1,or anti-PDL2agent or with an agent direct to anoth stimul or coinhib T-cell recep(eg,CTLA-4,OX-40,CD137)
7Has receiv prior ther with olaparib or with any otherPARPinhib
8Had maj surgery<4 weeks prior to the 1°dose of study medicat(exc for placem of vasc acc)
9Is expect to require any other form of antineopl ther,while on study
10Has receiv a live or live-attenuated vaccine within 30days before the first dose of stu interv.Administration of killed vaccines is allowed
11Has receiv colony-stim factors(e.g., G-CSF, GM-CSF, or recombinant erythropoietin)within28days prior to the1°dose of stu interv
12Is current receiv either strong or moder induc ofCYP3A4that cannot be discontin for the dur of the stu.The required washout per prior to start olaparib is5weeks for pentobarbital and3weeks for other agents
13Is current receiv either strong or moder inhib of cytochrP450(CYP)3A4that cannot be discontin for the dur of the stu.The requir washout per prior to start olaparib is2weeks
14Pemetrexed-specific:Is unable to interrupt aspirin or otherNSAIDs,other than an aspirin dose=1.3g per day,for at least2days(5days for long-acting agents[eg, piroxicam])before,during,and for at least2days after admin of pemetrexed
15Pemetrexed-specific:Is unable/unwilling to take folic ac,vitB12,and dexamethasone
16Is curr particip in or has particip in a stu of an investig agent or has used an investig dev within4weeks prior to the1°dose of stu interv
17The presence of uncontrolled,potentially revers cardiac cond,as judged by the investig or particip has congenital longQTsyndr
18Has a diagn of immunodef or is receiv chronic syst steroid ther(in dos exceeding10mgdaily of prednisone equiv)or any other form of immunosup ther within7days prior the1°dose of stu medic
19Has a known addit malignancy that is progressing or has requir act treatm within the past5years
20Has sev hypersens(=Grade3)to stu interv and/or any of its excip
21Has an active autoim dis that has requir syst treatm in past2years(ie,with use of disease modif agents,corticosteroids or immunosup drugs).Replacem ther(eg,thyroxine,insulin,or physiol corticosteroid replacem ther for adrenal or pituitary insuf)is not consider a form of syst treatm and is allowed
22Has a hist of(noninfectious)pneumon/interstit lung disease that requir steroids or has curr pneumonitis/interstitial lung dis.Lymphangitic spread of the NSCLC isn’t exclus
23Has an act infect requir syst ther
24Has a known hist of HIVinfection.NoHIVtest is requir unless mandated by local health author
25Has a known hist of HepatitisB(defined asHBsAg reactive)or known act HepC virus(defined as HCV RNA[qualitat]is detected)infect
26Has act tuberc and is receiv treatm
27Has a hist or current evid of any cond,ther,or lab abnormal that might confound the res of the study,interf with the participant's particip for the full dur of the study,or is not in the best inter of the particip to particip,in the opin of the treat investig
28In the opin of the treat investig,is consid a poor med risk due to a serious
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method