Le Chevalier 1994.

Methods	Randomized multi‐center phase III trial Eligible patients Cytologically or histologically confirmed NSCLC Stage III or stage IV disease; considered inoperable No previous chemotherapy ≤ 75 years of age 1 unirradiated measurable lesion WHO PS: 0 to 2 Adequate hepatic and renal function No symptomatic brain metastasis No uncontrolled infection No prior malignancy except adequately controlled basal cell carcinoma of the skin Exclusion criteria Not presented
Participants	VNR arm: 206 participants (ITT population) ‐ median age (range): 60 (NR) years/elderly participants not reported C‐VNR arm: 206 participants (ITT population) ‐ median age (range): 59 (NR) years/elderly participants not reported C‐VDS arm: 200 participants (ITT population) ‐ median age (range): 59 (NR) years/elderly participants not reported
Interventions	VNR arm: vinorelbine 30 mg/m2 over 20‐minute i.v. infusion weekly C‐VNR arm: cisplatin 120 mg/m2 over 1‐hour i.v. infusion on days 1 and 29, then every 6 weeks, plus vinorelbine 30 mg/m2 weekly C‐VDS arm: cisplatin 120 mg/m2 over 1‐hour i.v. infusion on days 1 and 29, then every 6 weeks, plus vindesine 3 mg/m2 weekly for 6 weeks, then every 2 weeks
Outcomes	Primary endpoint Survival defined as time from randomization until death or loss to follow‐up. Study planned first for comparison of 2 cisplatin‐containing arms; then, the better of these 2 groups was compared with the NVB arm Secondary endpoints Response according to WHO criteria at 10 and 18 weeks of treatment Tolerance according to WHO criteria
Notes	No additional data retrieved from the study. Data no longer accessible to study author
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization was centralized and treatment arms were allocated using a computer‐generated list stratified by centre and stage (stage IIIA and local recurrence v stage IIIB and metastatic disease to avoid an imbalance in the random allocation of potentially curable patients)"
Allocation concealment (selection bias)	Unclear risk	No information on allocation concealment
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome	Unclear risk	No information on blinding of outcome assessors for OS and 1yOS but study considered to have unclear impact on mortality outcomes
Blinding of outcome assessment (detection bias) Other outcomes	High risk	No information on blinding of assessors
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	"Twenty‐four patients (4%) were deemed ineligible: five had cerebral metastasis at the time of inclusion, two had a previous malignancy, two had errors in diagnosis, five had a PS 3, and 10 had no measurable lesion. They were distributed as follows: nine to NVB‐ P, 11 to VDS‐P, and four to NVB" No information provided for elderly subgroup
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias
Other bias	Unclear risk	Elderly subgroup analysis not planned nor performed