Study study type
PathologyT1T0Patientssample sizesROB Results

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RATIONALE 303 unpublished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...

     

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