NCT00883779

A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Placebo	po on days 15-28 of each 4 week cycle until disease progression
DRUG	Platinum chemotherapy (cisplatin or carboplatin)	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
DRUG	erlotinib [Tarceva]	150mg po on days 15-28 of each 4 week cycle until disease progression
DRUG	gemcitabine	1250mg/m2 iv on days 1 and 8 of each 4 week cycle for 6 cycles

Timeline

• Start date: 2009-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-04-20
• Last updated: 2015-12-14
• Results posted: 2015-12-14

Locations

26 sites across 7 countries: China, Hong Kong, Indonesia, Philippines, South Korea, Taiwan, Thailand