metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)
versus docetaxel
	sotorasib
	CodeBreaK 200, 2022 NCT04303780	RCT	metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)	oral sotorasib (960 mg daily)	intravenous docetaxel (75 mg/m2 every 3 weeks)	KRAS G12C-mutated NSCLC who progressed after prior platinum-based chemotherapy and a checkpoint inhibitor	169 / 151	NA	conclusif	demonstrated 34 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
	sotorasib NICE ITC 1 unpublished	IND	metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)	sotorasib	docetaxel monotherapy	SLECT 1 patients with KRASmutated (including KRAS p.G12C -mutated) NSCLC	-/-	NA	suggested	suggested 40 % decrease in deaths (OS),deaths (OS) suggested 59 % decrease in progression or deaths (PFS),progression or deaths (PFS)
	sotorasib NICE ITC Flatiron unpublished	IND	metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)	sotorasib	docetaxel monotherapy		-/-	NA	suggested	suggested 37 % decrease in deaths (OS),deaths (OS)
versus no control (uncontrolled study)
	sotorasib
	CodeBreaK 100, 2021 N Engl J Med 2021 Jun 24;384(25):2371-2381. NCT03600883	DESC	KRAS gene alteration defined cancer, metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)	otorasib, administered orally at a dose of 960 mg once daily		patients with KRAS p.G12C-mutated advanced NSCLC previously treated with standard therapies	124	NA	no results	no results
	trametinib plus dabrafenib
	BRF113928 unpublished NCT01336634	NRa	metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)	dabrafenib (150 mg orally twice daily) and trametinib (2 mg orally once daily)		patients with locally confirmed BRAF V600E mutation-positive metastatic NSCLC	-/-	NA	no results	no results
mNSCLC - L2 - all population metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - all population
versus docetaxel
	atezolizumab alone
	OAK (all population), 2016 Lancet 2017;389:255-265 Clin Lung Cancer 2018; 19:e405-e415 Clin Lung Cancer 2018; 19:441-449.e4 Eur. J. Cancer 2019; 107:124-132 J Thorac Oncol 2018; 13:1156-1170 J Med Econ 2019; 22:625-637 Lung Cancer 2019 Feb;128:105-112. NCT02008227	RCT	mNSCLC - L2 - all population	atelozumab	docetaxel	patients with locally advanced or metastatic (IIIB and IV) non-small cell lung cancer (NSCLC) who have failed platinum therapy	613 / 612	some concern	conclusif	demonstrated 20 % decrease in deaths (OS) (PE)
	POPLAR, 2016 Lancet 2016;387:1837-46 J Immunother Cancer 2019; 7:249 NCT01903993	RCT	mNSCLC - L2 - all population	atezolizumab	docetaxel	patients with locally advanced or metastatic non-small cell lung cancer who have failed platinum therapy	144 / 143	some concern	conclusif	demonstrated 27 % decrease in deaths (OS) (PE)
	avelumab alone
	JAVELIN Lung 200 (all population), 2018 Lancet Oncol. 2018; 19:1468-1479 J Thorac Oncol 2021 Apr 9;S1556-0864(21)01832-3. NCT02395172	RCT	mNSCLC - L2 - all population	avelumab	docetaxel	patients with stage IIIB, IV, or recurrent NSCLC with disease progression after previous platinum doublet treatment	396 / 396	some concern	inconclusive	no statistically significant result
	nivolumab alone
	CheckMate 078, 2019 J Thorac Oncol 2019; 14:867-875 Lung Cancer 2020 Nov 24;152:7-14. Lung Cancer 2021 Dec 27;165:71-81. NCT02613507	RCT	mNSCLC - L2 - all population	nivolumab	docetaxel	Patients 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 / 166	some 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	RCT	mNSCLC - L2 - all population	Tislelizumab	Docetaxel	Patients 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 J Thorac Oncol 2019 May;14(5):933-939. NCT02454933	RCT	mNSCLC - L2 - EGFR mutant	durvalumab plus osimertinib	osimertinib	Patients with EGFR T790M mutation positive locally advanced/metastatic NSCLC (stage IIIB–IV) (previous treatment 1 to >4)	14 / 15	some 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 Clin Lung Cancer 2016; 17:232-236.e1 Ann Oncol 2020 May;31(5):609-618. NCT02352948	RCT	mNSCLC - L2 - PDL1 negative	durvalumab plus tremelimumab	standard of care : erlotinib, gemcitabine or vinorelbine	patients 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 / 118	some 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 Lancet 2017;389:255-265 Clin Lung Cancer 2018; 19:e405-e415 Clin Lung Cancer 2018; 19:441-449.e4 Eur. J. Cancer 2019; 107:124-132 J Thorac Oncol 2018; 13:1156-1170 J Med Econ 2019; 22:625-637 Lung Cancer 2019 Feb;128:105-112. NCT02008227	RCT	mNSCLC - L2 - PDL1 positive	atelozumab	docetaxel	patients with locally advanced or metastatic (IIIB and IV) non-small cell lung cancer (NSCLC) who have failed platinum therapy, only patients with PDL1 TC 1/2/3	347 / 337	some 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 Lancet Oncol. 2018; 19:1468-1479 J Thorac Oncol 2021 Apr 9;S1556-0864(21)01832-3. NCT02395172	RCT	mNSCLC - L2 - PDL1 positive	avelumab	docetaxel	patients with stage IIIB, IV, or recurrent NSCLC with disease progression after previous platinum doublet treatment PDL1 positive population	264 / 265	some concern	suggested	inconclusive 10 % decrease in deaths (OS),deaths (OS) (PE)
	pembrolizumab (10mg/kg)
	KEYNOTE-010 (P:10 mg/kg), 2016 Lancet 2016;387:1540-50 Ann. Oncol. 2019; 30:281-289 J Thorac Oncol 2019 May;14(5):793-801. NCT01905657	RCT	mNSCLC - L2 - PDL1 positive	pembrolizumab 10 mg/kg	docetaxel	patients with previously treated (one line or more) non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells	346 / 343	high	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 Lancet 2016;387:1540-50 Ann. Oncol. 2019; 30:281-289 J Thorac Oncol 2019 May;14(5):793-801. NCT01905657	RCT	mNSCLC - L2 - PDL1 positive	pembrolizumab 10 mg/kg	docetaxel	patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells	151 / 152	high	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 Lancet 2016;387:1540-50 Ann. Oncol. 2019; 30:281-289 J Thorac Oncol 2019 May;14(5):793-801. NCT01905657	RCT	mNSCLC - L2 - PDL1 positive	pembrolizumab 2 mg/kg	docetaxel	patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells	139 / 152	high	conclusif	demonstrated 46 % decrease in deaths (OS) (PE) demonstrated 41 % decrease in progression or deaths (PFS) (PE)
	KEYNOTE-010 (P: 2mg/kg), 2016 Lancet 2016;387:1540-50 Ann. Oncol. 2019; 30:281-289 J Thorac Oncol 2019 May;14(5):793-801. NCT01905657	RCT	mNSCLC - L2 - PDL1 positive	pembrolizumab 2 mg/kg	docetaxel	patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells	344 / 343	high	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 Clin Lung Cancer 2016; 17:232-236.e1 Ann Oncol 2020 May;31(5):609-618. NCT02352948	RCT	mNSCLC - L2 - PDL1 positive	durvalumab	standard of care : erlotinib, gemcitabine or vinorelbine	patients 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 / 64	some 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 N Engl J Med 2015;373:1627-39 Eur. J. Cancer 2018; 102:23-30 J. Clin. Oncol. 2017; 35:3924-3933 J Clin Oncol 2021 Mar 1;39(7):723-733. NCT01673867	RCT	non squamous - mNSCLC - L2 - all population	nivolumab	docetaxel	Patients with advanced (stage IIIb or IV or recurrent) nonsquamous NSCLC that had progressed during or after platinum-based chemotherapy	292 / 290	some 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 J Thorac Oncol 2018; 13:194-204 J. Clin. Oncol. 2017; 35:3924-3933 N. Engl. J. Med. 2015; 373:123-35 J Clin Oncol 2021 Mar 1;39(7):723-733. NCT01642004	RCT	squamous - mNSCLC - L2 - all population	Nivolumab	Docetaxel	Patients with stage IIIB or IV squamous-cell NSCLC who had disease recurrence after only one prior platinum-containing regimen	135 / 137	some 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...

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

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

mNSCLC - L2 - EGFR mutant metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - EGFR mutant

mNSCLC - L2 - PDL1 negative metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - PDL1 negative

mNSCLC - L2 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2) mNSCLC - L2 - PDL1 positive

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

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