Study study type PathologyT1T0Patientssample sizesROB Results

locally advanced NSCLC - (neo)adjuvant (NA) locally advanced NSCLC - (neo)adjuvant (NA)

versus placebo plus SoC
nivolumab plus SoC
CheckMate 816, 2022
  NCT02998528
RCTlaNSCLC - NA - all populationnivolumab plus platinum doubletplacebo plus platinum doubletpatients with stage IB to IIIA resectable NSCLC, before surgery179 / 179NA
suggested
  • suggested 12.9-fold increase in pCR (PE)
The results show that the Opdivo/chemotherapy treatment met the primary endpoint of pathologic complete response (pCR), with significantly more patients treated with the combination therapy showing no evidence of cancer cells in their resected tissue compared with the placebo arm

laNSCLC - M - all population locally advanced NSCLC - maintenance (M) laNSCLC - M - all population

versus placebo
durvalumab alone
PACIFIC, 2017
  NCT02125461
RCTlaNSCLC - M - all populationDurvalumab as consolidation therapyplacebopatients with stage III unresectable NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy (consolidation therapy)476 / 237low
conclusif
  • demonstrated 32 % decrease in deaths (OS) (PE)
  • demonstrated 48 % decrease in progression or deaths (PFS) (PE)
  • suggested 28 % decrease in deaths (OS) (extension)
  • suggested 45 % decrease in PFS (extension)
  • more...

mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population

versus placebo plus SoC
sintillimab plus SoC
ORIENT-11, 2020
  NCT03607539
RCTmNSCLC - L1 - all populationSintilimab plus pemetrexed plus platineplacebo plus pemetrexed plus platinepatients with confirmed stage IIIB to IV nonsquamous NSCLC who had no previous systemic treatment for advanced and metastatic disease.266 / 131low
conclusif
  • suggested 39 % decrease in deaths (OS)
  • demonstrated 52 % decrease in progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
cemiplimab
EMPOWER lung1 (all population), 2021
  NCT03088540
RCTmNSCLC - L1 - all populationcemiplimabICCpatients with confirmed stage IIIB or IIICor stage IV squamous or non-squamous non-small-celllung cancer356 / 354some concern
conclusif
  • demonstrated 32 % decrease in deaths (OS) (PE)
  • demonstrated 41 % decrease in progression or deaths (PFS) (PE)
  • demonstrated 1.2-fold increase in objective responses (ORR) (PE)
durvalumab alone
MYSTIC (D ; all population), 2020
  NCT02453282
RCTmNSCLC - L1 - all populationdurvalumabplatinum-based doublet chemotherapyfirst-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%374 / 372some concern
inconclusive
    no statistically significant result
durvalumab plus tremelimumab
MYSTIC (DT ; all population), 2020
  NCT02453282
RCTmNSCLC - L1 - all populationdurvalumab and tremelimumabplatinum-based doublet chemotherapyfirst-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%372 / 372some concern
inconclusive
    no statistically significant result
nivolumab plus ipilimumab plus SoC
CheckMate 9LA, 2021
  NCT03215706
RCTmNSCLC - L1 - all populationnivo plus ipi and chemo (2 cycle)chemotherapy platine combinationpatient treated as First Line Therapy in squamous or non-squamous stage IV or recurrentNSCLC361 / 358some concern
conclusif
  • demonstrated 31 % decrease in deaths (OS) (PE)
  • demonstrated 30 % decrease in progression or deaths (PFS) (PE)
  • suggested 34 % decrease in deaths (OS) (extension)
  • suggested 32 % decrease in PFS (extension)
  • more...

mNSCLC - L1 - PDL1 negative metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 negative

versus pemetrexed plus platin
nivolumab plus SoC
CheckMate 227 (NC vs C ; PDL1<1%), 2018
  NCT02477826
RCTmNSCLC - L1 - PDL1 negativenivolumab plus pemetrexed plus platineplatinum based chemotherapy (pemetrexed plus platine)patients with histologically confirmed squamous or nonsquamous stage IV or recurrent NSCLC who had received no previous systemic anticancer therapy and TMB > 10mut/Mb177 / 186some concern
conclusif
  • demonstrated 27 % decrease in progression or deaths (PFS) (PE)

mNSCLC - L1 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 positive

versus pembrolizumab plus placebo
pembrolizumab plus ipilimumab
KEYNOTE-598, 2020
  NCT03302234
RCTmNSCLC - L1 - PDL1 positivepembrolizumab plus ipilimumabplacebo plus pembrolizumabas first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50% and no EGFR or ALK aberrations284 / 284low
inconclusive
  • inconclusive 8 % increase in deaths (OS) (PE)
  • inconclusive 6 % increase in progression or deaths (PFS) (PE)
versus pemetrexed plus platin
nivolumab plus ipilimumab
CheckMate 227 (NI vs C ; PDL1>1%), 2018
  NCT02477826
RCTmNSCLC - L1 - PDL1 positivenivolumab plus ipilimumabplatinium chemotherapypatients with histologically confirmed squamous or nonsquamous stage IV or recurrent NSCLC who had received no previous systemic anticancer therapy and PDL1>1%396 / 397some concern
conclusif
  • demonstrated 21 % decrease in deaths (OS) (PE)
  • suggested 18 % decrease in progression or deaths (PFS)
versus Standard of Care (SoC)
atezolizumab alone
IMpower-110 (TC2/3 or IC2/3), 2020
 
NCT02409342
RCTmNSCLC - L1 - PDL1 positiveatezolizumabplatinium chemotherapyPD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC2/3)166 / 162some concern
suggested
  • suggested 28 % decrease in deaths (OS) (PE)
  • suggested 36 % decrease in PFS (extension)
  • suggested 33 % decrease in progression or deaths (PFS)
IMpower-110 (TC1/2/3 or IC1/2/3), 2020
  NCT02409342
RCTmNSCLC - L1 - PDL1 positiveatezolizumabplatinium chemotherapyPD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC 1/2/3)277 / 277some concern
inconclusive
  • inconclusive 17 % decrease in deaths (OS) (PE)
  • suggested 28 % decrease in PFS (extension)
  • suggested 23 % decrease in progression or deaths (PFS)
IMpower-110 (TC3 or IC3), 2020
 
NCT02409342
RCTmNSCLC - L1 - PDL1 positiveatezolizumabplatinum chemotherapyPD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC 3)107 / 98some concern
conclusif
  • demonstrated 41 % decrease in deaths (OS) (PE)
  • suggested 41 % decrease in PFS (extension)
  • suggested 37 % decrease in progression or deaths (PFS)
cemiplimab
EMPOWER lung1 (PDL1>50%), 2021
  NCT03088540
RCTmNSCLC - L1 - PDL1 positivecemiplimabICCpatients with confirmed stage IIIB or IIICor stage IV squamous or non-squamous non-small-celllung cancer with PD-L1 expressed in at least 50% oftumour cells283 / 280some concern
suggested
  • suggested 43 % decrease in deaths (OS) (PE)
  • suggested 46 % decrease in progression or deaths (PFS) (PE)
durvalumab alone
MYSTIC (D ; PDL1>25%), 2020
  NCT02453282
RCTmNSCLC - L1 - PDL1 positivedurvalumabplatinum-based doublet chemotherapyfirst-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%163 / 162some concern
inconclusive
  • inconclusive 24 % decrease in deaths (OS) (PE)
durvalumab plus tremelimumab
MYSTIC (DT ; PDL1>25%), 2020
  NCT02453282
RCTmNSCLC - L1 - PDL1 positivedurvalumab and tremelimumabplatinum-based doublet chemotherapyfirst-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%163 / 162some concern
inconclusive
  • inconclusive 15 % decrease in deaths (OS) (PE)
  • inconclusive 5 % increase in progression or deaths (PFS) (PE)
nivolumab alone
CheckMate 026 (PDL1>1%), 2016
  NCT02041533
RCTmNSCLC - L1 - PDL1 positiveNivolumabplatinium doublet chemotherapypatients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC with PD-L1 >1%271 / 270some concern
inconclusive
    no statistically significant result
CheckMate 026 (PDL1>5%), 2016
  NCT02041533
RCTmNSCLC - L1 - PDL1 positiveNivolumabplatinum-based chemotherapypatients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC PD-L1 at >1%211 / 212some concern
inconclusive
  • inconclusive 15 % increase in progression or deaths (PFS) (PE)
pembrolizumab alone
KEYNOTE-042 (PDL1>50%), 2019
  NCT02220894
RCTmNSCLC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapypreviously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 50% or greater299 / 300some concern
conclusif
  • demonstrated 31 % decrease in deaths (OS) (PE)
  • suggested 2 % decrease in deaths (OS) (extension)
  • suggested 19 % decrease in progression or deaths (PFS)
KEYNOTE-042 (PDL1>20%), 2019
  NCT02220894
RCTmNSCLC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapypreviously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 20% or greater413 / 405some concern
conclusif
  • demonstrated 23 % decrease in deaths (OS) (PE)
  • suggested 25 % decrease in deaths (OS) (extension)
KEYNOTE-042 (PDL1>1%), 2019
  NCT02220894
RCTmNSCLC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapypreviously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 1% or greater637 / 637some concern
conclusif
  • demonstrated 19 % decrease in deaths (OS) (PE)
  • suggested 20 % decrease in deaths (OS) (extension)
KEYNOTE-024 (PDL1>50%), 2016
  NCT02142738
RCTmNSCLC - L1 - PDL1 positivePembrolizumabICC platinum-based chemotherapies regimenspatients who had previously untreated advanced stage IV NSCLC with PD-L1 expression on at least 50% of tumor cells154 / 151some concern
conclusif
  • demonstrated 40 % decrease in deaths (OS) (PE)
  • demonstrated 50 % decrease in progression or deaths (PFS) (PE)
  • suggested 38 % decrease in deaths (OS) (extension)
  • suggested 50 % decrease in PFS (extension)

mNSCLC - L1 - TMB>10Mb metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - TMB10Mb

versus pemetrexed plus platin
nivolumab plus ipilimumab
CheckMate 227 (NI vs C ; TMB >10 Mb), 2018
  NCT02477826
RCTmNSCLC - L1 - TMB>10Mbnivolumab plus ipilimumabplatinium chemotherapypatients with histologically confirmed squamous or nonsquamous stage IV or recurrent NSCLC who had received no previous systemic anticancer therapy and TMB > 10mut/Mb139 / 160some concern
conclusif
  • demonstrated 42 % decrease in progression or deaths (PFS) (PE)

non squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - all population

versus atezolizumab plus carboplatin plus nab-paclitaxel
atezolizumab plus carboplatin plus nab-paclitaxel
IMpower-130 (all population), 2019
  NCT02367781
RCTnon squamous - mNSCLC - L1 - all populationatezolizumab plus carboplatin plus nab-paclitaxel (ACnp)carboplatine plus nab-paclitaxel (CnP)first-line therapy for patients with stage IV non-squamous nonsmall- cell lung cancer and no ALK or EGFR mutations who have not previously received chemotherapy483 / 240some concern
conclusif
  • demonstrated 20 % decrease in deaths (OS) (PE)
  • demonstrated 35 % decrease in progression or deaths (PFS) (PE)
versus bevacizumab plus carboplatin and paclitaxel
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel
IMpower-150 (ABPC vs BPC ; all population) EXPLORATORY, 2018
  NCT02366143
RCTnon squamous - mNSCLC - L1 - all populationatezolizumab and bevacizumab, carboplatin plus paclitaxel (ABCP)bevacizumab plus carboplatin plus paclitaxel (BCP)patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.400 / 400some concern
inconclusive
  • suggested 24 % decrease in deaths (OS)
  • suggested 39 % decrease in progression or deaths (PFS)
atezolizumab plus carboplatin plus paclitaxel
IMpower-150 (ACP vs BCP ; all population, EXPLORATORY), 2018
  NCT02366143
RCTnon squamous - mNSCLC - L1 - all populationatezolizumab plus carboplatin plus paclitaxel (ACP)bevacizumab and caroplatin plus paclitaxel (BCP)patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.402 / 400some concern
inconclusive
    no statistically significant result

non squamous - mNSCLC - L1 - Wild Type (WT) metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - Wild Type (WT)

versus bevacizumab plus carboplatin and paclitaxel
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel
IMpower-150 (ABCP vs BPC WT), 2018
  NCT02366143
RCTnon squamous - mNSCLC - L1 - Wild Type (WT)atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (ABCP)bevacizumab and caroplatin plus paclitaxel (BCP)patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.356 / 336some concern
conclusif
  • demonstrated 22 % decrease in deaths (OS) (PE)
  • demonstrated 38 % decrease in progression or deaths (PFS) (PE)
IMpower-150 (ABCP vs BPC ; WT-Teff high), 2018
  NCT02366143
RCTnon squamous - mNSCLC - L1 - Wild Type (WT)atezolizumab and bevacizumab, carboplatin plus paclitaxel (ABCP)bevacizumab plus carboplatin plus paclitaxel (BCP)patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.155 / 129some concern
conclusif
  • demonstrated 49 % decrease in progression or deaths (PFS) (PE)
versus carboplatin plus nab-paclitaxel
atezolizumab plus carboplatin plus nab-paclitaxel
IMpower-130 (WT), 2019
  NCT02367781
RCTnon squamous - mNSCLC - L1 - Wild Type (WT)atezolizumab (ACnP) plus carboplatine plus nab-paclitaxelcarboplatine plus nab-paclitaxelfirst-line therapy for patients with stage IV non-squamous nonsmall- cell lung cancer who have not previously received chemotherapy. (EGFRwt and ALKwt)451 / 228some concern
conclusif
  • demonstrated 21 % decrease in deaths (OS) (PE)
  • demonstrated 36 % decrease in progression or deaths (PFS) (PE)
  • statistically significant 1.4-fold increase in DOR
versus pemetrexed plus platin
atezolizumab plus pemetrexed and platin
IMpower-132 (WT) unpublished
 
NCT02657434
RCTnon squamous - mNSCLC - L1 - Wild Type (WT)Atezolizumab (induction and maintenance) plus pemetrexed plus platinepemetrexed plus platineChemotherapy-naive patients with Stage IV non-squamous NSCLC without EGFR or ALK genetic alteration292 / 286NA
conclusif
  • inconclusive 19 % decrease in deaths (OS) (PE)
  • demonstrated 40 % decrease in progression or deaths (PFS) (PE)
pembrolizumab and pemetrexed plus platin
KEYNOTE-021, 2016
  NCT02039674
RCTnon squamous - mNSCLC - L1 - Wild Type (WT)pembrolizumab with carboplatin plus pemetrexedcarboplatin plus pemetrexedpatients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung cancer60 / 63some concern
conclusif
  • demonstrated 47 % decrease in progression or deaths (PFS) (PE)
  • suggested 46 % decrease in PFS (extension)
  • demonstrated 2.1-fold increase in objective responses (ORR) (PE)
versus placebo plus SoC
pembrolizumab plus SoC
KEYNOTE-189, 2018
  NCT02578680
RCTnon squamous - mNSCLC - L1 - Wild Type (WT)pembrolizumab plus pemetrexed plus platineplacebo plus pemetrexed plus platineparticipants with advanced or metastatic nonsquamous non-small cell lung cancer who have not previously received systemic therapy for advanced disease410 / 206low
conclusif
  • demonstrated 51 % decrease in deaths (OS) (PE)
  • demonstrated 48 % decrease in progression or deaths (PFS) (PE)
  • suggested 44 % decrease in deaths (OS) (extension)
  • suggested 52 % decrease in PFS (extension)
  • more...

squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) squamous cell - mNSCLC - L1 squamous - mNSCLC - L1 - all population

versus carboplatin plus nab-paclitaxel
atezolizumab plus carboplatin plus nab-paclitaxel
IMpower-131 (ACnP), 2020
  NCT02367794
RCTsquamous - mNSCLC - L1 - all populationatezolizumab plus carboplatine plus nab-paclitaxel(ACnP)carboplatine plus nab-paclitaxel (CnP)chemotherapy-naive participants with Stage IV squamous NSCLC343 / 340some concern
conclusif
  • inconclusive 12 % decrease in deaths (OS) (PE)
  • demonstrated 29 % decrease in progression or deaths (PFS) (PE)
  • statistically significant 1.1-fold increase in DOR
versus placebo plus SoC
ipilimumab plus SoC
CA184-104, 2017
 
NCT01285609
RCTsquamous - mNSCLC - L1 - all populationipilimumab plus paclitaxel and carboplatinplacebo plus paclitaxel and carboplatinpatients treated with first-line in advanced stage IV squamous NSCLC479 / 477high
inconclusive
  • inconclusive 9 % decrease in deaths (OS) (PE)
  • statistically significant 27 % decrease in objective responses (ORR)
pembrolizumab plus SoC
KEYNOTE-407, 2018
  NCT02775435
RCTsquamous - mNSCLC - L1 - all populationpembrolizumab plus platine and (nab)paclitaxelplacebo plus platine and (nab)paclitaxelpatients with confirmed stage IV squamous NSCLC who had received no previous systemic therapy for metastatic disease278 / 281low
conclusif
  • demonstrated 36 % decrease in deaths (OS) (PE)
  • demonstrated 44 % decrease in progression or deaths (PFS) (PE)

mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - all population

versus docetaxel
atezolizumab alone
OAK (all population), 2016
  NCT02008227
RCTmNSCLC - L2 - all populationatelozumabdocetaxelpatients with locally advanced or metastatic (IIIB and IV) non-small cell lung cancer (NSCLC) who have failed platinum therapy613 / 612some concern
conclusif
  • demonstrated 20 % decrease in deaths (OS) (PE)
POPLAR, 2016
  NCT01903993
RCTmNSCLC - L2 - all populationatezolizumabdocetaxelpatients with locally advanced or metastatic non-small cell lung cancer who have failed platinum therapy144 / 143some concern
conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
avelumab alone
JAVELIN Lung 200 (all population), 2018
  NCT02395172
RCTmNSCLC - L2 - all populationavelumabdocetaxelpatients with stage IIIB, IV, or recurrent NSCLC with disease progression after previous platinum doublet treatment396 / 396some concern
inconclusive
    no statistically significant result
nivolumab alone
CheckMate 078, 2019
  NCT02613507
RCTmNSCLC - L2 - all populationnivolumabdocetaxelPatients with stage IIIB or IV or recurrent squamous or nonsquamous NSCLC progressing during or after one previous platinumbased doublet chemotherapy regimen. (predominantly Chinese patient)338 / 166some concern
conclusif
  • demonstrated 32 % decrease in deaths (OS) (PE)
  • demonstrated 23 % decrease in progression or deaths (PFS) (PE)
  • suggested 25 % decrease in deaths (OS) (extension)
  • suggested 21 % decrease in PFS (extension)
  • more...
Tislelizumab
RATIONALE 303 unpublished
 
NCT03358875
RCTmNSCLC - L2 - all populationTislelizumabDocetaxelPatients With stage IIB or IV Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen-/-NA
no results
    no results
According to BeiGene, in the interim analysis, the study achieved the primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population

mNSCLC - L2 - EGFR mutant metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - EGFR mutant

versus osimertinib
durvalumab plus osimertinib
CAURAL (EXPLORATORY), 2019
  NCT02454933
RCTmNSCLC - L2 - EGFR mutantdurvalumab plus osimertinibosimertinibPatients with EGFR T790M mutation positive locally advanced/metastatic NSCLC (stage IIIB–IV) (previous treatment 1 to >4)14 / 15some concern
inconclusive
    no statistically significant result

mNSCLC - L2 - PDL1 negative metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - PDL1 negative

versus Standard of Care (SoC)
durvalumab plus tremelimumab
ARCTIC (DT ; study B ; PDL1<25%), 2020
  NCT02352948
RCTmNSCLC - L2 - PDL1 negativedurvalumab plus tremelimumabstandard of care : erlotinib, gemcitabine or vinorelbinepatients with PD-L1 positive locally advanced or metastatic non small cell lung cancer who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for stage IIIB/IV locally advanced or mNSCLC;174 / 118some concern
inconclusive
  • inconclusive 20 % decrease in deaths (OS) (PE)
  • inconclusive 23 % decrease in progression or deaths (PFS) (PE)

mNSCLC - L2 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - PDL1 positive

versus docetaxel
atezolizumab alone
OAK (PDL1 TC 1/2/3), 2016
  NCT02008227
RCTmNSCLC - L2 - PDL1 positiveatelozumabdocetaxelpatients with locally advanced or metastatic (IIIB and IV) non-small cell lung cancer (NSCLC) who have failed platinum therapy, only patients with PDL1 TC 1/2/3347 / 337some concern
conclusif
  • demonstrated 23 % decrease in deaths (OS) (PE)
  • statistically significant 8.6-fold increase in DOR
avelumab alone
JAVELIN Lung 200 (PDL1 >1%), 2018
  NCT02395172
RCTmNSCLC - L2 - PDL1 positiveavelumabdocetaxelpatients with stage IIIB, IV, or recurrent NSCLC with disease progression after previous platinum doublet treatment PDL1 positive population264 / 265some concern
suggested
  • inconclusive 10 % decrease in deaths (OS) (PE)
pembrolizumab (10mg/kg)
KEYNOTE-010 (P:10 mg/kg), 2016
  NCT01905657
RCTmNSCLC - L2 - PDL1 positivepembrolizumab 10 mg/kgdocetaxelpatients with previously treated (one line or more) non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells346 / 343high
conclusif
  • demonstrated 39 % decrease in deaths (OS) (PE)
  • suggested 21 % decrease in progression or deaths (PFS) (PE)
KEYNOTE-010 (P:10 mg/kg ; PDL1>50%), 2016
  NCT01905657
RCTmNSCLC - L2 - PDL1 positivepembrolizumab 10 mg/kgdocetaxelpatients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells151 / 152high
conclusif
  • demonstrated 50 % decrease in deaths (OS) (PE)
  • demonstrated 41 % decrease in progression or deaths (PFS) (PE)
  • suggested 45 % decrease in deaths (OS) (extension)
  • suggested 43 % decrease in PFS (extension)
pembrolizumab (2mg/kg)
KEYNOTE-010 (P: 2mg/kg ; PDL1>50%), 2016
  NCT01905657
RCTmNSCLC - L2 - PDL1 positivepembrolizumab 2 mg/kgdocetaxelpatients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells139 / 152high
conclusif
  • demonstrated 46 % decrease in deaths (OS) (PE)
  • demonstrated 41 % decrease in progression or deaths (PFS) (PE)
KEYNOTE-010 (P: 2mg/kg), 2016
  NCT01905657
RCTmNSCLC - L2 - PDL1 positivepembrolizumab 2 mg/kgdocetaxelpatients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells344 / 343high
conclusif
  • demonstrated 29 % decrease in deaths (OS) (PE)
  • inconclusive 12 % decrease in progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
durvalumab alone
ARCTIC (D ; study A ; PDL1>25% EXPLORATORY), 2020
  NCT02352948
RCTmNSCLC - L2 - PDL1 positivedurvalumabstandard of care : erlotinib, gemcitabine or vinorelbinepatients with PD-L1 positive locally advanced or metastatic non small cell lung cancer who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for stage IIIB/IV locally advanced or mNSCLC;62 / 64some concern
suggested
  • suggested 37 % decrease in deaths (OS)

non squamous - mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) non squamous cell - mNSCLC - L2 non squamous - mNSCLC - L2 - all population

versus docetaxel
nivolumab alone
CheckMate 057, 2015
  NCT01673867
RCTnon squamous - mNSCLC - L2 - all populationnivolumabdocetaxelPatients with advanced (stage IIIb or IV or recurrent) nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy292 / 290some concern
conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
  • demonstrated 70 % increase in objective responses (ORR) (PE)

squamous - mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) squamous cell - mNSCLC - L2 squamous - mNSCLC - L2 - all population

versus docetaxel
nivolumab alone
CheckMate 017, 2015
  NCT01642004
RCTsquamous - mNSCLC - L2 - all populationNivolumabDocetaxelPatients with stage IIIB or IV squamous-cell NSCLC who had disease recurrence after only one prior platinum-containing regimen135 / 137some concern
conclusif
  • demonstrated 41 % decrease in deaths (OS) (PE)
  • demonstrated 38 % decrease in progression or deaths (PFS) (PE)
  • suggested 69 % decrease in deaths (OS) (extension)
  • suggested 52 % decrease in PFS (extension)
  • more...

NSCLC neoadjuvant setting NSCLC neoadjuvant setting

versus placebo plus SoC
nivolumab plus SoC
CheckMate 816, 2022
  NCT02998528
RCTlaNSCLC - NA - all populationnivolumab plus platinum doubletplacebo plus platinum doubletpatients with stage IB to IIIA resectable NSCLC, before surgery179 / 179NA
suggested
  • suggested 12.9-fold increase in pCR (PE)
The results show that the Opdivo/chemotherapy treatment met the primary endpoint of pathologic complete response (pCR), with significantly more patients treated with the combination therapy showing no evidence of cancer cells in their resected tissue compared with the placebo arm