At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-controlled, Double-blind Phase III Study of the Effect of First-line Treatment With Intercalated Tarceva Versus Placebo in Combination With Gemcitabine/Platinum on Progression-free Survival in Patients With Stage IIIB/IV Non-small Cell Lung Cancer
In Brief
A Phase 3 clinical trial evaluating Placebo, Platinum chemotherapy (cisplatin or carboplatin), and 2 other interventions for Non-Squamous Non-Small Cell Lung Cancer. Completed, enrolled 451 participants across 26 sites in 7 countries.
Detailed Summary
This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Study Details
Timeline
Interventions
po on days 15-28 of each 4 week cycle until disease progression
cisplatin --75mg/m2 oon day 1 of each 4 week cycle for 6 cycles or carboplatin--5xAUC on day 1 of each 4 week cycle for 6 cycles
150mg po on days 15-28 of each 4 week cycle until disease progression
1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles