metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	Results
lung cancer : non small cell (NSCLC) lung cancer : non small cell (NSCLC)
versus no control (uncontrolled study)
	entrectinib
	ALKA-372-001, STARTRK-1, STARTRK-2 (lung cancer), 2020 Lancet Oncol 2020 Feb;21(2):271-282. J Clin Oncol 2021 Apr 10;39(11):1253-1263. NCT02568267	DESC	lung cancer : non small cell (NSCLC)	entrectinib ≥ 600 mg orally once per day		Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer	161	NA	no results	no results
	larotrectinib
	Drilon (basket), 2018 Lancet Oncol 2020 Apr;21(4):531-540. N Engl J Med 2018 Feb 22;378(8):731-739. NCT02576431	DESC	lung cancer : non small cell (NSCLC), NTRK gene alteration	larotrectinib		TRK Fusion-Positive Cancers in Adults and Children	-/-	NA	no results	no results
	pralsetinib
	ARROW unpublished Lancet Oncol 2021 Jul;22(7):959-969. NCT03037385	DESC	lung cancer : non small cell (NSCLC), RET gene alteration defined cancer	pralsetinib		adult patients with metastatic RET fusion-positive non-small cell lung cancer	114	NA	no results	no results
	selpercatinib
	LIBRETTO-001 trial (lung cancer) unpublished N Engl J Med 2020 Aug 27;383(9):813-824. NCT03157128	DESC	lung cancer : non small cell (NSCLC), RET gene alteration defined cancer	selpercatinib		patients with locally advanced or metastatic RET fusion-positive NSCLC	-/-	NA	no results	no 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
laNSCLC - M - all population locally advanced NSCLC - maintenance (M) laNSCLC - M - all population
versus placebo
	durvalumab alone
	PACIFIC, 2017 N Engl J Med 2017;377:1919-1929 N. Engl. J. Med. 2018; 379:2342-2350 Lancet Oncol. 2019; 20:1670-1680 Br J Cancer 2020 Dec;123(Suppl 1):18-27. World J Clin Oncol 2020 Nov 24;11(11):898-917. J Thorac Oncol 2021 May;16(5):860-867. Ann Oncol 2020 Jun;31(6):798-806. J Thorac Oncol 2020 Feb;15(2):288-293. J Natl Compr Canc Netw 2021 Feb 2;19(2):153-162. Lung Cancer 2021 Jan;151:30-38. Future Oncol 2021 Apr;17(10):1165-1184. Clin Lung Cancer. 2021 Jun 12;S1525-7304(21)00144-3 ESMO Open 2022; 7:100410-. J Clin Oncol 2022; 40:1301-1311-. NCT02125461	RCT	laNSCLC - M - all population	Durvalumab as consolidation therapy	placebo	patients with stage III unresectable NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy (consolidation therapy)	476 / 237	low	conclusif	demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 48 % decrease in progression or deaths (PFS) (PE) suggested 28 % decrease in deaths (OS) (extension) suggested 45 % decrease in PFS (extension) more...
mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population
versus placebo plus SoC
	sintillimab plus SoC
	ORIENT-11, 2020 J Thorac Oncol 2020 Aug 8;S1556-0864(20)30595-5. NCT03607539	RCT	mNSCLC - L1 - all population	Sintilimab plus pemetrexed plus platine	placebo plus pemetrexed plus platine	patients with confirmed stage IIIB to IV nonsquamous NSCLC who had no previous systemic treatment for advanced and metastatic disease.	266 / 131	low	conclusif	suggested 39 % decrease in deaths (OS) demonstrated 52 % decrease in progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
	cemiplimab
	EMPOWER lung1 (all population), 2021 Lancet 2021 Feb 13;397(10274):592-604. NCT03088540	RCT	mNSCLC - L1 - all population	cemiplimab	ICC	patients with confirmed stage IIIB or IIICor stage IV squamous or non-squamous non-small-celllung cancer	356 / 354	some concern	conclusif	demonstrated 32 % decrease in deaths (OS) (PE) demonstrated 41 % decrease in progression or deaths (PFS) (PE) demonstrated 1.2-fold increase in objective responses (ORR) (PE)
	durvalumab alone
	MYSTIC (D ; all population), 2020 JAMA Oncol 2020 May 1;6(5):661-674. NCT02453282	RCT	mNSCLC - L1 - all population	durvalumab	platinum-based doublet chemotherapy	first-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%	374 / 372	some concern	inconclusive	no statistically significant result
	durvalumab plus tremelimumab
	MYSTIC (DT ; all population), 2020 JAMA Oncol 2020 May 1;6(5):661-674. NCT02453282	RCT	mNSCLC - L1 - all population	durvalumab and tremelimumab	platinum-based doublet chemotherapy	first-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%	372 / 372	some concern	inconclusive	no statistically significant result
	nivolumab plus ipilimumab plus SoC
	CheckMate 9LA, 2021 Lancet Oncol 2021 Jan 18;S1470-2045(20)30641-0. ESMO Open. 2021 Oct 1 NCT03215706	RCT	mNSCLC - L1 - all population	nivo plus ipi and chemo (2 cycle)	chemotherapy platine combination	patient treated as First Line Therapy in squamous or non-squamous stage IV or recurrentNSCLC	361 / 358	some concern	conclusif	demonstrated 31 % decrease in deaths (OS) (PE) demonstrated 30 % decrease in progression or deaths (PFS) (PE) suggested 34 % decrease in deaths (OS) (extension) suggested 32 % decrease in PFS (extension) more...
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)
mNSCLC - L1 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 positive
versus pembrolizumab plus placebo
	pembrolizumab plus ipilimumab
	KEYNOTE-598, 2020 J Clin Oncol 2021 Jan 29;JCO2003579. NCT03302234	RCT	mNSCLC - L1 - PDL1 positive	pembrolizumab plus ipilimumab	placebo plus pembrolizumab	as first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50% and no EGFR or ALK aberrations	284 / 284	low	inconclusive	inconclusive 8 % increase in deaths (OS) (PE) inconclusive 6 % increase in progression or deaths (PFS) (PE)
versus pemetrexed plus platin
	nivolumab plus ipilimumab
	CheckMate 227 (NI vs C ; PDL1>1%), 2018 Eur J Cancer 2019 Jul;116:137-147. N Engl J Med 2018 May 31;378(22):2093-2104. 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. J Thorac Oncol. 2021 Oct 11;S1556-0864(21)03207-X NCT02477826	RCT	mNSCLC - L1 - PDL1 positive	nivolumab plus ipilimumab	platinium chemotherapy	patients with histologically confirmed squamous or nonsquamous stage IV or recurrent NSCLC who had received no previous systemic anticancer therapy and PDL1>1%	396 / 397	some concern	conclusif	demonstrated 21 % decrease in deaths (OS) (PE) suggested 18 % decrease in progression or deaths (PFS)
versus Standard of Care (SoC)
	atezolizumab alone
	IMpower-110 (TC2/3 or IC2/3), 2020 NCT02409342	RCT	mNSCLC - L1 - PDL1 positive	atezolizumab	platinium chemotherapy	PD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC2/3)	166 / 162	some concern	suggested	suggested 28 % decrease in deaths (OS),deaths (OS) (PE) suggested 36 % decrease in PFS (extension),PFS (extension) suggested 33 % decrease in progression or deaths (PFS),progression or deaths (PFS)
	IMpower-110 (TC1/2/3 or IC1/2/3), 2020 J Thorac Oncol . 2021 Jul 12;S1556-0864(21)02286-3. NCT02409342	RCT	mNSCLC - L1 - PDL1 positive	atezolizumab	platinium chemotherapy	PD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC 1/2/3)	277 / 277	some concern	inconclusive	inconclusive 17 % decrease in deaths (OS),deaths (OS) (PE) suggested 28 % decrease in PFS (extension),PFS (extension) suggested 23 % decrease in progression or deaths (PFS),progression or deaths (PFS)
	IMpower-110 (TC3 or IC3), 2020 NCT02409342	RCT	mNSCLC - L1 - PDL1 positive	atezolizumab	platinum chemotherapy	PD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC 3)	107 / 98	some concern	conclusif	demonstrated 41 % decrease in deaths (OS),deaths (OS) (PE) suggested 41 % decrease in PFS (extension),PFS (extension) suggested 37 % decrease in progression or deaths (PFS),progression or deaths (PFS)
	cemiplimab
	EMPOWER lung1 (PDL1>50%), 2021 Lancet 2021 Feb 13;397(10274):592-604. NCT03088540	RCT	mNSCLC - L1 - PDL1 positive	cemiplimab	ICC	patients with confirmed stage IIIB or IIICor stage IV squamous or non-squamous non-small-celllung cancer with PD-L1 expressed in at least 50% oftumour cells	283 / 280	some concern	suggested	suggested 43 % decrease in deaths (OS) (PE) suggested 46 % decrease in progression or deaths (PFS) (PE)
	durvalumab alone
	MYSTIC (D ; PDL1>25%), 2020 JAMA Oncol 2020 May 1;6(5):661-674. NCT02453282	RCT	mNSCLC - L1 - PDL1 positive	durvalumab	platinum-based doublet chemotherapy	first-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%	163 / 162	some concern	inconclusive	inconclusive 24 % decrease in deaths (OS),deaths (OS) (PE)
	durvalumab plus tremelimumab
	MYSTIC (DT ; PDL1>25%), 2020 JAMA Oncol 2020 May 1;6(5):661-674. NCT02453282	RCT	mNSCLC - L1 - PDL1 positive	durvalumab and tremelimumab	platinum-based doublet chemotherapy	first-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%	163 / 162	some concern	inconclusive	inconclusive 15 % decrease in deaths (OS),deaths (OS) (PE) inconclusive 5 % increase in progression or deaths (PFS),progression or deaths (PFS) (PE)
	nivolumab alone
	CheckMate 026 (PDL1>5%), 2016 N Engl J Med 2017 Jun 22;376(25):2415-2426. NCT02041533	RCT	mNSCLC - L1 - PDL1 positive	Nivolumab	platinum-based chemotherapy	patients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC PD-L1 at >1%	211 / 212	some concern	inconclusive	inconclusive 15 % increase in progression or deaths (PFS) (PE)
	CheckMate 026 (PDL1>1%), 2016 N Engl J Med 2017 Jun 22;376(25):2415-2426. NCT02041533	RCT	mNSCLC - L1 - PDL1 positive	Nivolumab	platinium doublet chemotherapy	patients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC with PD-L1 >1%	271 / 270	some concern	inconclusive	no statistically significant result
	pembrolizumab alone
	KEYNOTE-042 (PDL1>20%), 2019 Lancet 2019;393:1819-1830 Immunotherapy 2019; 11:1463-1478 Lung Cancer 2019; 135:188-195 NCT02220894	RCT	mNSCLC - L1 - PDL1 positive	pembrolizumab	platinium based chemotherapy	previously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 20% or greater	413 / 405	some concern	conclusif	demonstrated 23 % decrease in deaths (OS) (PE) suggested 25 % decrease in deaths (OS) (extension)
	KEYNOTE-042 (PDL1>1%), 2019 Lancet 2019;393:1819-1830 Immunotherapy 2019; 11:1463-1478 Lung Cancer 2019; 135:188-195 NCT02220894	RCT	mNSCLC - L1 - PDL1 positive	pembrolizumab	platinium based chemotherapy	previously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 1% or greater	637 / 637	some concern	conclusif	demonstrated 19 % decrease in deaths (OS) (PE) suggested 20 % decrease in deaths (OS) (extension)
	KEYNOTE-042 (PDL1>50%), 2019 Lancet 2019;393:1819-1830 Immunotherapy 2019; 11:1463-1478 Lung Cancer 2019; 135:188-195 Int J Cancer 2020 Nov 24. NCT02220894	RCT	mNSCLC - L1 - PDL1 positive	pembrolizumab	platinium based chemotherapy	previously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 50% or greater	299 / 300	some concern	conclusif	demonstrated 31 % decrease in deaths (OS) (PE) suggested 2 % decrease in deaths (OS) (extension) suggested 19 % decrease in progression or deaths (PFS)
	KEYNOTE-024 (PDL1>50%), 2016 N Engl J Med 2016;375:1823-1833 Lancet Oncol. 2017; 18:1600-1609 J. Clin. Oncol. 2019; 37:537-546 Lung Cancer 2019; 135:188-195 Cancer Sci 2020 Sep 14. J Clin Oncol 2021 Apr 19;JCO2100174. NCT02142738	RCT	mNSCLC - L1 - PDL1 positive	Pembrolizumab	ICC platinum-based chemotherapies regimens	patients who had previously untreated advanced stage IV NSCLC with PD-L1 expression on at least 50% of tumor cells	154 / 151	some concern	conclusif	demonstrated 40 % decrease in deaths (OS) (PE) demonstrated 50 % decrease in progression or deaths (PFS) (PE) suggested 38 % decrease in deaths (OS) (extension) suggested 50 % decrease in PFS (extension)
mNSCLC - L1 - TMB>10Mb metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - TMB10Mb
versus pemetrexed plus platin
	nivolumab plus ipilimumab
	CheckMate 227 (NI vs C ; TMB >10 Mb), 2018 Eur J Cancer 2019 Jul;116:137-147. N Engl J Med 2018 May 31;378(22):2093-2104. Oncology (Williston Park) 2020 Jul 15;34(7):254. N Engl J Med 2019 Nov 21;381(21):2020-2031. J Thorac Oncol 2021 Apr;16(4):665-676. NCT02477826	RCT	mNSCLC - L1 - TMB>10Mb	nivolumab plus ipilimumab	platinium chemotherapy	patients with histologically confirmed squamous or nonsquamous stage IV or recurrent NSCLC who had received no previous systemic anticancer therapy and TMB > 10mut/Mb	139 / 160	some concern	conclusif	demonstrated 42 % decrease in progression or deaths (PFS) (PE)
non squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - all population
versus atezolizumab plus carboplatin plus nab-paclitaxel
	atezolizumab plus carboplatin plus nab-paclitaxel
	IMpower-130 (all population), 2019 Lancet Oncol. 2019; 20:924-937 NCT02367781	RCT	non squamous - mNSCLC - L1 - all population	atezolizumab plus carboplatin plus nab-paclitaxel (ACnp)	carboplatine plus nab-paclitaxel (CnP)	first-line therapy for patients with stage IV non-squamous nonsmall- cell lung cancer and no ALK or EGFR mutations who have not previously received chemotherapy	483 / 240	some concern	conclusif	demonstrated 20 % decrease in deaths (OS) (PE) demonstrated 35 % decrease in progression or deaths (PFS) (PE)
versus bevacizumab plus carboplatin and paclitaxel
	atezolizumab plus bevacizumab plus carboplatin plus paclitaxel
	IMpower-150 (ABPC vs BPC ; all population) EXPLORATORY, 2018 N. Engl. J. Med. 2018; 378:2288-2301 Lancet Respir Med 2019; 7:387-401 Cancers Br J Cancer. 2022 Jan;126(1):42-47 NCT02366143	RCT	non squamous - mNSCLC - L1 - all population	atezolizumab and bevacizumab, carboplatin plus paclitaxel (ABCP)	bevacizumab plus carboplatin plus paclitaxel (BCP)	patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.	400 / 400	some concern	inconclusive	suggested 24 % decrease in deaths (OS) suggested 39 % decrease in progression or deaths (PFS)
	atezolizumab plus carboplatin plus paclitaxel
	IMpower-150 (ACP vs BCP ; all population, EXPLORATORY), 2018 N. Engl. J. Med. 2018; 378:2288-2301 Lancet Respir Med 2019; 7:387-401 NCT02366143	RCT	non squamous - mNSCLC - L1 - all population	atezolizumab plus carboplatin plus paclitaxel (ACP)	bevacizumab and caroplatin plus paclitaxel (BCP)	patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.	402 / 400	some concern	inconclusive	no statistically significant result
non squamous - mNSCLC - L1 - Wild Type (WT) metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - Wild Type (WT)
versus bevacizumab plus carboplatin and paclitaxel
	atezolizumab plus bevacizumab plus carboplatin plus paclitaxel
	IMpower-150 (ABCP vs BPC WT), 2018 N. Engl. J. Med. 2018; 378:2288-2301 Lancet Respir Med 2019; 7:387-401 J Thorac Oncol. 2021 Jul 24 J Thorac Oncol 2022; 17:309-323-. NCT02366143	RCT	non squamous - mNSCLC - L1 - Wild Type (WT)	atezolizumab plus bevacizumab plus carboplatin plus paclitaxel (ABCP)	bevacizumab and caroplatin plus paclitaxel (BCP)	patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.	356 / 336	some concern	conclusif	demonstrated 22 % decrease in deaths (OS) (PE) demonstrated 38 % decrease in progression or deaths (PFS) (PE)
	IMpower-150 (ABCP vs BPC ; WT-Teff high), 2018 N. Engl. J. Med. 2018; 378:2288-2301 Lancet Respir Med 2019; 7:387-401 NCT02366143	RCT	non squamous - mNSCLC - L1 - Wild Type (WT)	atezolizumab and bevacizumab, carboplatin plus paclitaxel (ABCP)	bevacizumab plus carboplatin plus paclitaxel (BCP)	patients with stage IV or recurrent metastatic nonsquamous NSCLC who had not previously received chemotherapy.	155 / 129	some concern	conclusif	demonstrated 49 % decrease in progression or deaths (PFS) (PE)
versus carboplatin plus nab-paclitaxel
	atezolizumab plus carboplatin plus nab-paclitaxel
	IMpower-130 (WT), 2019 Lancet Oncol. 2019; 20:924-937 NCT02367781	RCT	non squamous - mNSCLC - L1 - Wild Type (WT)	atezolizumab (ACnP) plus carboplatine plus nab-paclitaxel	carboplatine plus nab-paclitaxel	first-line therapy for patients with stage IV non-squamous nonsmall- cell lung cancer who have not previously received chemotherapy. (EGFRwt and ALKwt)	451 / 228	some concern	conclusif	demonstrated 21 % decrease in deaths (OS) (PE) demonstrated 36 % decrease in progression or deaths (PFS) (PE) statistically significant 1.4-fold increase in DOR
versus pemetrexed plus platin
	atezolizumab plus pemetrexed and platin
	IMpower-132 (WT) unpublished NCT02657434	RCT	non squamous - mNSCLC - L1 - Wild Type (WT)	Atezolizumab (induction and maintenance) plus pemetrexed plus platine	pemetrexed plus platine	Chemotherapy-naive patients with Stage IV non-squamous NSCLC without EGFR or ALK genetic alteration	292 / 286	NA	conclusif	inconclusive 19 % decrease in deaths (OS),deaths (OS) (PE) demonstrated 40 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
	pembrolizumab and pemetrexed plus platin
	KEYNOTE-021, 2016 Lancet Oncol 2016;17:1497-1508 J Thorac Oncol 2019 Jan;14(1):124-129. J Thorac Oncol 2019 Mar;14(3):553-559. J Thorac Oncol 2020 Sep 28;S1556-0864(20)30761-9. NCT02039674	RCT	non squamous - mNSCLC - L1 - Wild Type (WT)	pembrolizumab with carboplatin plus pemetrexed	carboplatin plus pemetrexed	patients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung cancer	60 / 63	some concern	conclusif	demonstrated 47 % decrease in progression or deaths (PFS) (PE) suggested 46 % decrease in PFS (extension) demonstrated 2.1-fold increase in objective responses (ORR) (PE)
versus placebo plus SoC
	pembrolizumab plus SoC
	KEYNOTE-189, 2018 N Engl J Med 2018;378:2078-2092 Lancet Oncol. 2020; 21:387-397 J Med Econ 2018; 21:1191-1205 J Clin Oncol 2020; 38:1505-1517 Lung Cancer 2021 Feb 19;155:53-60. Ann Oncol 2021 Apr 21;S0923-7534(21)01146-7. NCT02578680	RCT	non squamous - mNSCLC - L1 - Wild Type (WT)	pembrolizumab plus pemetrexed plus platine	placebo plus pemetrexed plus platine	participants with advanced or metastatic nonsquamous non-small cell lung cancer who have not previously received systemic therapy for advanced disease	410 / 206	low	conclusif	demonstrated 51 % decrease in deaths (OS) (PE) demonstrated 48 % decrease in progression or deaths (PFS) (PE) suggested 44 % decrease in deaths (OS) (extension) suggested 52 % decrease in PFS (extension) more...
squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) squamous cell - mNSCLC - L1 squamous - mNSCLC - L1 - all population
versus carboplatin plus nab-paclitaxel
	atezolizumab plus carboplatin plus nab-paclitaxel
	IMpower-131 (ACnP), 2020 J Thorac Oncol 2020 Aug;15(8):1351-1360. NCT02367794	RCT	squamous - mNSCLC - L1 - all population	atezolizumab plus carboplatine plus nab-paclitaxel(ACnP)	carboplatine plus nab-paclitaxel (CnP)	chemotherapy-naive participants with Stage IV squamous NSCLC	343 / 340	some concern	conclusif	inconclusive 12 % decrease in deaths (OS),deaths (OS) (PE) demonstrated 29 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE) statistically significant 1.1-fold increase in DOR,DOR
versus placebo plus SoC
	ipilimumab plus SoC
	CA184-104, 2017 NCT01285609	RCT	squamous - mNSCLC - L1 - all population	ipilimumab plus paclitaxel and carboplatin	placebo plus paclitaxel and carboplatin	patients treated with first-line in advanced stage IV squamous NSCLC	479 / 477	high	inconclusive	inconclusive 9 % decrease in deaths (OS) (PE) statistically significant 27 % decrease in objective responses (ORR)
	pembrolizumab plus SoC
	KEYNOTE-407, 2018 N Engl J Med 2018;379:2040-2051 J. Clin. Oncol. 2020; 38:271-280 NCT02775435	RCT	squamous - mNSCLC - L1 - all population	pembrolizumab plus platine and (nab)paclitaxel	placebo plus platine and (nab)paclitaxel	patients with confirmed stage IV squamous NSCLC who had received no previous systemic therapy for metastatic disease	278 / 281	low	conclusif	demonstrated 36 % decrease in deaths (OS) (PE) demonstrated 44 % decrease in progression or deaths (PFS) (PE)
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), 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)
	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)
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...
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

lung cancer : non small cell (NSCLC) lung cancer : non small cell (NSCLC)

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

laNSCLC - M - all population locally advanced NSCLC - maintenance (M) laNSCLC - M - all population

mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population

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

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

mNSCLC - L1 - TMB>10Mb metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - TMB10Mb

non squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - all population

non squamous - mNSCLC - L1 - Wild Type (WT) metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - Wild Type (WT)

squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) squamous cell - mNSCLC - L1 squamous - mNSCLC - L1 - all population

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

NSCLC neoadjuvant setting NSCLC neoadjuvant setting