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	ARROW unpublished Lancet Oncol 2021 Jul;22(7):959-969.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	LIBRETTO-001 trial (lung cancer) unpublished N Engl J Med 2020 Aug 27;383(9):813-824.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
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) (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	sotorasib NICE ITC 1 unpublished	IND	metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)	sotorasib	docetaxel monotherapy	SLECT 1 patients with KRASmutated (including KRAS p.G12C -mutated) NSCLC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) suggested 59 % decrease in 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	sotorasib NICE ITC Flatiron unpublished	IND	metastatic/advanced NSCLC (mNSCLC) - 2nd line (L2)	sotorasib	docetaxel monotherapy		-/-	NA	suggested	suggested 37 % decrease in deaths (OS)
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

Study

study type

Pathology

Patients

sample sizes

ROB

Results

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

NCT02576431

DESC

lung cancer : non small cell (NSCLC), NTRK gene alteration

larotrectinib

TRK Fusion-Positive Cancers in Adults and Children

-/-

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

NCT03157128

DESC

lung cancer : non small cell (NSCLC), RET gene alteration defined cancer

selpercatinib

patients with locally advanced or metastatic RET fusion-positive NSCLC

-/-

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

demonstrated 34 % decrease in progression or deaths (PFS) (PE)

IND

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

sotorasib

docetaxel monotherapy

SLECT 1 patients with KRASmutated (including KRAS p.G12C -mutated) NSCLC

-/-

suggested 40 % decrease in deaths (OS)
suggested 59 % decrease in progression or deaths (PFS)

IND

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

sotorasib

docetaxel monotherapy

-/-

suggested 37 % decrease in deaths (OS)

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

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

-/-

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

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