NCT01186861

Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Placebo Plus Erlotinib in Patients With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

A Randomized, Double-Blind, Placebo-controlled Phase 2 Study of Maintenance OSI-906 Plus Erlotinib (Tarceva®), or Erlotinib Plus Placebo in Patients With Nonprogression Following Four Cycles of 1st-line Platinum-based Chemotherapy for Advanced NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled, phase 2 study with a 1:1 randomization scheme.

Detailed description

Adult patients with advanced Non-small Cell Lung Cancer (NSCLC) and nonprogression after platinum-based chemotherapy will be randomized 1:1 to receive either OSI-906 plus erlotinib or placebo plus erlotinib.

Conditions

• Non-Small Cell Lung Cancer (NSCLC) With Nonprogression Following 4 Cycles of Platinum-based Chemotherapy

Interventions

Type	Name	Description
DRUG	OSI-906	Tablet administered with food and with up to 200 mL of water
DRUG	erlotinib	Tablet administered at least 2 hours after food with up to 200 mL of water
DRUG	placebo	Tablet administered at least 2 hours after food with up to 200 mL of water

Timeline

• Start date: 2011-03-04
• Primary completion: 2013-07-01
• Completion: 2015-03-11
• First posted: 2010-08-23
• Last updated: 2025-11-18

Locations

69 sites across 9 countries: United States, Brazil, Canada, Germany, Poland, Romania, Russia, South Korea, United Kingdom