Mazzanti 2003.

Methods	Inclusion: Eligible participants had to meet the following criteria: histologically or cytologically confirmed NSCLC; stage IIIB or IV NSCLC (according to the American Joint Committee on Cancer staging system, 1992); PS 0 to 2 on the ECOG scale; aged 18 to 75 years; at least 1 measurable lesion; life expectancy > 12 weeks; adequate bone marrow, hepatic, cardiac, and renal function. Participants who had received previous radiotherapy were included if their assessable disease was outside of the radiation field. Exclusion: Patients were ineligible if they had: symptomatic central nervous system metastases; second primary malignancy; serious systemic disorders.
Participants	Arm I: 58 people Arm II: 62 people
Interventions	Arm I: gemcitabine (1200 mg/m2) iv over 30 minutes on days 1 and 8 and cisplatin (80 mg/m2) iv over 45 minutes on day 2, every 3 weeks Arm II: gemcitabine (1200 mg/m2) iv over 30 minutes on days 1 and 8 and carboplatin (AUC 5 mg/mL X minutes) iv over 1 hour on day 2, every 3 weeks
Outcomes	Primary outcome: response rate Secondary outcomes: duration of response toxicity time to progression overall survival 1‐year survival
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The randomisation algorithm, based on the Pocock and Simon method (Pocock 1975), included ECOG PS (0/1 vs 2) and disease stage (IIIB vs IV) as stratification factors.
Allocation concealment (selection bias)	Low risk	Eligible participants were randomised to 1 of 2 arms, GCb or GC, using a concealed list of random numbers. The randomisation algorithm was based on the Pocock and Simon method.
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	High risk	5 participants were randomly assigned to the GC arm, but were ineligible to receive treatment (3 with an ECOG PS of 3 at baseline, 1 pretreated with chemotherapy, and 1 affected by a serious cardiac disease).
Selective reporting (reporting bias)	Low risk	No evidence of selective reporting bias
Other bias	High risk	The trial was planned as a randomised phase II study to obtain information for further development in a controlled randomised phase III setting, thus the findings obtained from the treatment arm comparisons of this phase II study should be considered as exploratory.