Vansteenkiste 2001.

Methods	Randomized multi‐center phase III trial Eligible patients Histologically or cytologically confirmed NSCLC Stage IIIB (inoperable) or IV ≥ 1 bi‐dimensionally measurable lesion No previous chemotherapy and radiotherapy allowed provided irradiated area was not the only measurable target lesion KPS ≥ 60% and life expectancy > 3 months Symptomatic, defined as visual analogue scale (VAS) score ≥ 20/100 for ≥ 1 symptom Adequate bone marrow, liver, and renal function Exclusion criteria Active infection Symptomatic central nervous system metastases Serious concomitant systemic disorders incompatible with the study History of previous or current second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) Use of investigational agent month before enrolment
Participants	G arm: 84 participants (ITT population) ‐ median age (SD): 63.7 (±8.2) years/elderly subgroup not reported PV arm: 85 participants (ITT population) ‐ median age (SD): 63.1 (±8.6) years/elderly subgroup not reported
Interventions	G arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion days 1, 8, and 15, every 28‐day cycle without standard use of antiemetics (after first cycle prophylactic non‐5‐HT3‐ antagonist antiemetics allowed at discretion of the investigator) PV arm: cisplatin 100 mg/m2 over 1 to 4‐hour i.v. infusion on day 1 and vindesine 3 mg/m2 (maximum 5 mg) on days 1 and 15, every 28‐day cycle with standard pre‐hydration, forced diuresis, and use of 5‐HT3‐antagonists
Outcomes	Outcomes Time‐to‐response: defined as interval between randomisation and first evaluation indicating a response Response duration: defined as time from achievement of objective response until disease progression Time‐to‐progression: defined as interval between randomisation and first documentation of disease progression Survival: defined as interval between randomisation and death, or date of last contact for censored participants Definitions of primary or secondary outcomes
Notes	Despite multiple attempts to contact study authors, no further data on elderly subgroup provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"After this, and after a thorough eligibility check, randomisation between a treatment with GEM or PV was carried out by fax at a central location for all sites" Randomization performed according to CONSORT guidelines
Allocation concealment (selection bias)	Low risk	"Each patient's study drug regimen was unknown until the time of randomisation"
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome	Unclear risk	Trial designed as open‐label
Blinding of outcome assessment (detection bias) Other outcomes	Low risk	"All claimed responses and stable diseases were to be reviewed by a panel including at least two oncologists (never reviewing their own patients), one research nurse, and one independent external radiologist blinded to treatment"
Incomplete outcome data (attrition bias) All outcomes	Low risk	No evidence of attrition bias
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias
Other bias	Unclear risk	Study designed for the general population; elderly subgroup analysis not planned