metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
locally advanced NSCLC - (neo)adjuvant (NA) locally advanced NSCLC - (neo)adjuvant (NA)
versus placebo plus SoC
	nivolumab plus SoC
	CheckMate 816, 2022 N Engl J Med 2022 Apr 11. NCT02998528	RCT	laNSCLC - NA - all population	nivolumab plus platinum doublet	placebo plus platinum doublet	patients with stage IB to IIIA resectable NSCLC, before surgery	179 / 179	NA	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 N Engl J Med 2018 May 31;378(22):2093-2104. Eur J Cancer 2019 Jul;116:137-147. N Engl J Med 2019 Nov 21;381(21):2020-2031. Oncology (Williston Park) 2020 Jul 15;34(7):254. J Thorac Oncol 2021 Apr;16(4):665-676. NCT02477826	RCT	mNSCLC - L1 - PDL1 negative	nivolumab plus pemetrexed plus platine	platinum 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/Mb	177 / 186	some concern	conclusif	demonstrated 27 % decrease in progression or deaths (PFS) (PE)
NSCLC neoadjuvant setting NSCLC neoadjuvant setting
versus placebo plus SoC
	nivolumab plus SoC
	CheckMate 816, 2022 N Engl J Med 2022 Apr 11. NCT02998528	RCT	laNSCLC - NA - all population	nivolumab plus platinum doublet	placebo plus platinum doublet	patients with stage IB to IIIA resectable NSCLC, before surgery	179 / 179	NA	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

Study

study type

Pathology

Patients

sample sizes

ROB

Results

NCT02998528

RCT

laNSCLC - NA - all population

nivolumab plus platinum doublet

placebo plus platinum doublet

patients with stage IB to IIIA resectable NSCLC, before surgery

179 / 179

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

NCT02477826

RCT

mNSCLC - L1 - PDL1 negative

nivolumab plus pemetrexed plus platine

platinum 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/Mb

177 / 186

demonstrated 27 % decrease in progression or deaths (PFS) (PE)

NCT02998528

RCT

laNSCLC - NA - all population

nivolumab plus platinum doublet

placebo plus platinum doublet

patients with stage IB to IIIA resectable NSCLC, before surgery

179 / 179

suggested 12.9-fold increase in pCR (PE)

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

versus placebo plus SoC

nivolumab plus SoC

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

versus pemetrexed plus platin

nivolumab plus SoC

NSCLC neoadjuvant setting NSCLC neoadjuvant setting

versus placebo plus SoC

nivolumab plus SoC