Flotten 2012.

Methods	Randomized multi‐center phase III trial Inclusion criteria Stage IIIB (not eligible for curative treatment) or IV non‐small cell lung cancer PS: 0 to 2 No defined upper age limit Adequate bone marrow and liver function Patients with brain metastasis allowed Exclusion criteria Other active malignancy Gastrointestinal disease affecting absorption of vinorelbine
Participants	VG arm: 215 (ITT population)/38 (participants ≥ 75 years old) VC arm: 222 (ITT population)/36 (participants ≥ 75 years old)
Interventions	VG arm: vinorelbine 60 mg/m2 orally plus gemcitabine 1000 mg/m2 on days 1 and 8, every 3 weeks for planned 3 cycles VC arm: vinorelbine 60 mg/m2 orally on days 1 and 8 plus carboplatin AUC5 on day 1, every 3 weeks for planned 3 cycles Participants ≥ 75 years of age had doses reduced by 25% Both groups received prophylactic antiemetics with an i.v. glucocorticoid and a 5‐HT3 antagonist on day 1, and VG participants also on day 8. VC participants received oral 5‐HT3 antagonist twice daily on day 8
Outcomes	Primary outcome Overall survival: defined Seconday outcomes Health‐related quality of life (HRQoL): defined global QoL at week 9 as primary HRQoL endpoint Toxicity Use of palliative radiotherapy
Notes	Participants underwent chest X‐ray and CT scan of thorax and upper abdomen before randomization and chest X‐ray at week 9 and every 8 weeks thereafter Further imaging to determine disease progression performed at treating physician's discretion. Study not designed to assess response rate nor time‐to‐progression Disease progression, unacceptable toxicity, and participant request were reasons for discontinuation of study treatment Despite contact with study authors, we retrieved no data related to outcomes among the elderly population
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	After participants had signed the informed consent form and had completed the baseline HRQoL form, they were randomly assigned by phone to the central study office at Haukeland University Hospital, Bergen, Norway. Randomization was stratified by WHO PS 0 to 1 vs 2, stage IIB vs IV, and < 75 vs ≥ 75 years of age
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	Unclear risk	Seven participants excluded from all analyses ‐ 'six because of ineligibility and one because of administration of wrong study therapy.' Three participants received no study treatment. No information on number of randomly assigned elderly who were not assessable
Selective reporting (reporting bias)	High risk	Study not designed to assess response or time‐to‐progression. Disease progression, unacceptable toxicity, and participant request were reasons for discontinuation of study treatment. Imaging for disease progression analysis done at treating physician's discretion. HRQoL analysis not reported for the elderly subgroup. Only OS data available for the elderly
Other bias	Unclear risk	Study designed for general population; elderly subgroup analysis planned