Fossella 2003.

Methods	Inclusion: Participants with histological or cytological diagnosis of locally advanced or recurrent (stage IIIB ) or metastatic (stage IV) NSCLC who met the following criteria: ≥ 18 years of age; Karnofsky PS ≥ 70; at least 1 measurable or assessable lesion; adequate bone marrow, hepatic, and renal function. Exclusion: Patients were ineligible if they had: prior treatment with a biological response modifier or chemotherapeutic agent; previous or concurrent malignant disease (except cone‐biopsied carcinoma in‐situ of the cervix or adequately treated basal or squamous cell carcinoma of the skin); history of brain or leptomeningeal metastases (except if adequately treated and radiologically stable for at least 4 weeks); peripheral neuropathy of National Cancer Institute common toxicity criteria grade II or above; major surgery within 2 weeks of study entry; radiotherapy within 4 weeks of study entry; other serious concomitant illness.
Participants	Arm I: 408 people Arm II: 406 people
Interventions	Arm I: docetaxel (75 mg/m2) iv over 1 hour on day 1 and cisplatin (75 mg/m2) iv over 1 hour on day 1, every 3 weeks Arm II: docetaxel (75 mg/m2) iv over 1 hour on day 1 and carboplatin (AUC 6 mg/mL X minutes) iv on day 1, every 3 weeks Arm III: vinorelbine and cisplatin (not used in this review)
Outcomes	Primary outcome: overall survival Secondary outcomes: response rate toxicity QoL (LCSS and the global QoL scale (EQ‐5D))
Notes	Arm III (vinorelbine and cisplatin) was not used in this review. Arm III: vinorelbine (25 mg/m2) iv on days 1, 8, 15, and 22 plus cisplatin (100 mg/m2) iv on day 1, every 4 weeks
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Before random assignment to treatment, participants were stratified according to disease stage (IIIB vs IV) and geographic region (North America vs South Africa, New Zealand and Australia vs Europe, Lebanon and Israel vs South America).
Allocation concealment (selection bias)	Low risk	Random assignment to treatment was conducted by an independent research organisation using computer‐generated lists.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open‐label trial
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label trial
Incomplete outcome data (attrition bias) All outcomes	Low risk	Of the 1218 participants, 15 did not receive treatment (9 were ineligible, 4 withdrew consent, and 2 died of malignant disease before the first drug infusion) and were excluded from the safety analysis.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting bias
Other bias	Low risk	No other bias