Study study type PathologyT1T0Patientssample sizesROB Results deaths (OS) Eprogression or deaths (PFS) ERFS/DFS E

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

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 -22% demonstrated-27%

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 2% 15%
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 7% 17%

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% demonstrated-23%

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% -8%

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% demonstrated-38%

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