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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

NCT01186861 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2025-11-18

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-04
Primary Completion
2013-07-01
Completion
2015-03-11

Countries

  • United States
  • Brazil
  • Canada
  • Germany
  • Poland
  • Romania
  • Russia
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01186861 on ClinicalTrials.gov