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

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 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...

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

 

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