Yamamoto 2006.

Methods	Randomized phase II trial Eligible patients Histologically or cytologically confirmed NSCLC, stage IIIB (not candidate for thoracic radiation) or IV Measurable disease Life expectancy ≥ 3 months Between 20 and 74 years of age PS: 0 to 1 on ECOG scale Adequate bone marrow, renal, pulmonary, and liver function Exclusion criteria Active concomitant malignancy Symptomatic brain metastasis Prior radiotherapy to sole site of measurable disease Past history of severe allergic reactions to drugs Interstitial pneumonia identified by chest X‐ray, cirrhosis, superior vena cava syndrome, or other serious complication
Participants	GV arm: 64 participants (ITT population) ‐ median age (range): 62 (36 to 74) years/elderly participants included not reported CG arm: 64 participants (ITT population) ‐ median age (range): 60 (30 to 74) years/elderly participants included not reported
Interventions	GV arm: gemcitabine 1000 mg/m2 in 100 mL of normal saline solution as 30‐minute i.v. infusion and vinorelbine 25 mg/m2 in 20 mL of normal saline solution as 5‐minute i.v. infusion on days 1 and 8, every 3 weeks GC arm: gemcitabine given at a dose of 1000 mg/m2 in 100 mL of normal saline solution as 30‐minute i.v. infusion on days 1 and 8. Carboplatin administered at area under the curve (AUC) of 5 in 500 mL of normal saline solution as 60‐minute i.v. infusion on day 1 only, every 3 weeks. Antiemetics (5HT‐3 antagonists and dexamethasone) permitted as prophylaxis for nausea and vomiting. GCSF allowed for participants with grade 4 leukopenia, grade 4 neutropenia, or febrile neutropenia, according to investigator decision
Outcomes	Primary outcome Overall survival: defined as time from randomisation to death or last follow‐up information for participants still alive Secondary outcome Progression‐free survival: defined as time from randomisation to disease progression or death, whichever occurred first, or last follow‐up information for those still live and presenting with no disease progression
Notes	Despite multiple attempts to contact study authors, no data related to elderly subgroup analysis
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Patients were assigned randomly to receive the GC regimen or the GV regimen and were stratified by disease stage (Stage IIIB vs. Stage IV), prior treatment (yes vs. no), and institution"
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	Unclear risk	"In the GV arm, 2 patients did not receive trial therapy because of deterioration in their condition. These 2 patients were excluded from the analysis of toxicity, response, and progression‐free survival"
Selective reporting (reporting bias)	Low risk	No evidence of reporting bias
Other bias	Unclear risk	No separate elderly subgroup analysis