Lilenbaum 2005b.

Methods	Randomized phase II trial Inclusion criteria Confirmed NSCLC Stage IIIB or stage IV disease Measurable or evaluable disease Prior radiotherapy allowed if it did not encompass index lesion(s) and was completed ≥ 2 weeks before protocol enrollment No previous chemotherapy ≥ 18 years of age (no upper age restriction) PS: 0 to 2 Adequate hematological, hepatic, and renal function Exclusion criteria Brain metastasis with neurological deficit or taking corticosteroids after definitive radiotherapy Prior history of malignancy, except for carcinoma in situ of the cervix or breast, non‐melanoma skin cancer Respiratory insufficiency and oxygen dependency, severe cardiac disease, history of hypersensitivity to Cremophor, pre‐existing ≥ grade 3 peripheral neuropathy, according to WCI criteria; pregnant women HIV positive
Participants	GV arm: 82 participants (ITT population) ‐ median age (range): 66 (42 to 86) years/number of elderly participants not reported CP arm: 83 participants (ITT population) ‐ median age (range): 63 (38 to 86) years/number of elderly participants not reported
Interventions	GV arm: vinorelbine 25 mg/m2 i.v. infusion plus gemcitabine 1000 mg/m2 i.v. infusion, both given on days 1 and 8, every 3 weeks up to 6 cycles CP arm: paclitaxel 200 mg/m2 i.v. infusion plus carboplatin AUC6 according to Calvert formula, both administered on day 1 every 3 weeks up to 6 cycles
Outcomes	Primary outcome Quality of life assessment by Lung Cancer Symptom Scale (LCSS) Secondary outcomes Response rate (by WHO criteria) Time‐to‐progression Overall survival
Notes	No additional data accessible, despite contact with study author
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients were randomised to receive vinorelbine(...)" Random sequence generation not reported
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not reported
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome	Unclear risk	Open‐label study considered to have unclear impact on mortality outcomes
Blinding of outcome assessment (detection bias) Other outcomes	High risk	Open‐label study
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	Elderly subgroup analysis neither planned nor performed. Unplanned subgroup analysis not retrieved