Study study type
PathologyT1T0Patientssample sizesROB Results

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

versus Standard of Care (SoC)
nivolumab alone
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)
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

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

versus docetaxel
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...

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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