NCT01656551.
Trial name or title | A Factorial Study Comparing Pemetrexed With Gemcitabine and Testing the Efficacy of the Addition of Cisplatin in Elderly Patients With Non‐Squamous Advanced, Metastatic, or Recurrent NSCLC |
Methods | Controlled randomized trial, open‐label, multi‐center. This study used a factorial design that allowed 2 comparisons: single‐agent therapy vs chemotherapy plus cisplatin (arms A + C vs arms B + D), and gemcitabine vs pemetrexed (arms A + B vs arms C + D) |
Participants | Eligibility criteria Inclusion criteria
Exclusion criteria
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Interventions | Arm A (active comparator): gemcitabine 1200 mg/m2 days 1 and 8, every 3 weeks Arm B (experimental arm): cisplatin 60 mg/m2 day 1 + gemcitabine 1000 mg/m2 days 1 and 8, every 3 weeks Arm C (active comparator): pemetrexed 500 mg/m2 i.v. day 1, every 3 weeks Arm D (experimental arm): cisplatin 60 mg/m2 day 1 + pemetrexed 500 mg/m2 day 1, every 3 weeks |
Outcomes | Primary outcome
Secondary outcomes
Other outcome measures
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Starting date | July 2012 |
Contact information | Francesco Perrone, M.D., Ph.D.; +39 081 5903571; email: francesco.perrone@usc‐intnapoli.net Maria Carmela Piccirillo, M.D.; +39 081 5903681; email: marilina.piccirillo@usc‐intnapoli.net |
Notes |