Rosell 2002.

Methods	Inclusion: Eligible participants were required to meet all of the following criteria: histological or cytological diagnosis of NSCLC; stage IIIB or IV; ≥ 18 years; PS of 0, 1, or 2 on ECOG scale with a predicted life expectancy of at least 12 weeks; no prior chemotherapy; any radiotherapy completed > 3 weeks before enrolment and the person recovered from any adverse effects; adequate baseline bone marrow, liver, and kidney functions; participants had to be able to understand the EORTC QLQ‐C30. Exclusion: Patients were ineligible if they had: history of prior or concomitant malignancy (except for curatively treated non‐melanoma skin cancer or carcinoma in situ of the cervix or other cancer for which the participant had been disease‐free for 5 years); active or uncontrolled infection; symptomatic brain metastases; pregnancy, lactation, or refusal to use contraception; peripheral neuropathy; uncontrolled diabetes mellitus; significant cardiovascular disease or other serious medical condition.
Participants	Arm I: 309 people Arm II: 309 people
Interventions	Arm I: paclitaxel (200 mg/m2) iv over 3 hours and cisplatin (80 mg/m2) iv over 30 minutes every 3 weeks Arm II: paclitaxel (200 mg/m2) iv over 3 hours and carboplatin (AUC 6 mg/mL X minutes) iv over 30 minutes every 3 weeks
Outcomes	Primary outcome: response rate, according to WHO criteria Secondary outcomes: median survival; progression‐free survival; toxicity; QoL measured by the EORTC QLQ‐C30 and QLQ‐LC13
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	This procedure minimised imbalance in treatment assignment with respect to the following parameters: centre, PS (ECOG 0 or 1 vs 2), disease stage (IIIB vs IV), and histology (squamous cell vs non‐squamous cell carcinoma).
Allocation concealment (selection bias)	Low risk	Randomisation was performed centrally by Bristol‐Myers Squibb Inc, Waterloo, Belgium, using a dynamic balancing algorithm of the Pocock‐Simon type.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No information about blinding process
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information about blinding process
Incomplete outcome data (attrition bias) All outcomes	Low risk	10 people (2%) never received a study drug (3 in carboplatin arm and 7 in cisplatin arm). This was considered unlikely to result in a significant bias.
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting bias
Other bias	High risk	The only bias was that dose reduction of carboplatin was necessary for 96 of the 279 (34%) evaluable participants; this reduction occurred mainly during course 1, due to a miscalculation of AUC. The mean AUC for these 96 participants was 4.9 mg/mL X minutes.