Chen 2008.

Methods	Randomized phase II trial Eligible patients Histologically or cytologically confirmed NSCLC Stage IIIB (including patients with malignant pleural effusion) or IV disease ≥ 70 years of age Bi‐dimensionally measurable disease No previous chemotherapy or immunotherapy PS 0 to 2 (WHO scale) Adequate bone marrow function Exclusion criteria Signs or symptoms of brain metastases Inadequate liver function (bilirubin > 1.5 times and ALT/AST > 3 times upper normal limit) Inadequate renal function with creatinine > 2.0 mg/dL Second primary malignancies, except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, excluded from the study
Participants	V arm: 31 elderly participants ‐ median age (range): 76.5 (70 to 82) years/PS 2: 16/stage IV: 29 CV arm: 35 elderly participants ‐ median age (range): 75.6 (70 to 83) years/PS 2:16/stage IV: 27
Interventions	V arm: vinorelbine 25 mg/m2 over 10‐minute i.v. infusion on days 1 and 8, every 3 weeks CV: cisplatin 50 mg/m2 over 6‐hour i.v. infusion on day 1 and vinorelbine 22.5 mg/m2 over 10‐minute i.v. infusion on days 1 and 8, every 3 weeks Planned maximum number of cycles: 6 for responding participants and 4 for those with stable disease
Outcomes	Primary outcome Response rate (according to RECIST) ‐ Study designed to accrue ≥ 28 qualified participants in each arm, assuming 10% better response for best treatment Secondary outcomes Toxicity (according to NCI‐CTC version 2) Time‐to‐tumor progression (defined as time from randomization to disease progression or death) Overall survival (defined as time from randomization to death from any cause) Quality of life according to Lung Cancer Symptom Scale ‐ recorded before every cycle of chemotherapy when participant completed and went off the study
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Patients were randomised into the vinorelbine (V) or vinorelbine plus cisplatin (VP) treatment arm by an outside centre not involved in the study" ‐ no further information regarding randomization process
Allocation concealment (selection bias)	Unclear risk	No information on allocation concealment analysis
Blinding of outcome assessment (detection bias) OS and 1y OS rate outcome	Unclear risk	Open‐label study considered to have unclear influence 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	Small phase II trial, designed to evaluate differences in response rate between treatment arms