Saito 2012.

Methods	Randomized phase II trial Inclusion criteria Histologically confirmed NSCLC Stage IIIB or IV Age > 18 years Measurable or evaluable disease PS: 2 No previous chemotherapy Life expectancy > 3 months Brain metastasis permitted as long as treated with surgery or radiotherapy and stable No concomitant malignancy Exclusion criteria Active and serious infection Massive pleural or pericardial effusion that required drainage Concomitant serious cardiovascular disease Neuropathy ≥ grade 2 Pregnant or lactating female
Participants	GV arm: 43 participants (ITT population) ‐ median age (range): 67 (34 to 76) years/number of elderly not reported CP arm: 41 participants (ITT population) ‐ median age (range): 65 (20 to 77) years/number of elderly not reported
Interventions	CP arm: carboplatin AUC6 over 60‐minute i.v. infusion and paclitaxel 200 mg/m2 over 3‐hour i.v. infusion on day 1, every 3 weeks GV arm: gemcitabine 1000 mg/m2 over 30‐minute i.v. infusion and vinorelbine 25 mg/m2 over 6 to 10‐minute i.v. infusion on days 1 and 8, every 3 weeks
Outcomes	Primary outcome 1‐Year survival rate (1yOS) ‐ study assumed baseline rate of 20% 1yOS and designed to select better treatment with 85% probability if baseline exceeded Secondary outcomes Time‐to‐progression Response rate Symptom improvement (according to Lung Cancer Subscale of the Functional Assessment of Cancer Therapy‐Lung Quality Life Instrument version 4.0, at 3 and 6 weeks after initiation of therapy) Toxicity
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Eligible patients were randomly assigned to 1 of the 2 treatment arms by a minimization method with disease stage (IIIB vs. IV) and body weight loss in the previous 6 months (<5% vs. >5%) as stratifying variables. Randomization was performed at the West Japan Thoracic Oncology Group (now known as the West Japan Oncology Group) Data Center"
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
Blinding of outcome assessment (detection bias) Other outcomes	High risk	No information on blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Two patients were subsequently considered to be ineligible and 3 did not receive the protocol treatment"
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias
Other bias	Unclear risk	No separate elderly subgroup analysis