NCT00760929

A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).

A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progression After First or Second Line Chemotherapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<500 individuals.

Conditions

• Non-Squamous Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Placebo	iv 9mg/kg weekly
DRUG	Placebo	iv 16mg/kg every 3 weeks
DRUG	RG1507	iv 9mg/kg weekly
DRUG	RG1507	iv 16mg/kg every 3 weeks
DRUG	erlotinib [Tarceva]	150mg oral daily

Timeline

• Start date: 2008-11-10
• Primary completion: 2010-06-25
• Completion: 2010-06-25
• First posted: 2008-09-26
• Last updated: 2021-01-05
• Results posted: 2021-01-05

Locations

57 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Italy, Poland, Spain, United Kingdom