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Completed Phase 2 Interventional

Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

ClinicalTrials.gov ID: NCT01221077

Public ClinicalTrials.gov record NCT01221077. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Phase 2 Study of Erlotinib (Tarceva®) in Combination With OSI-906 or Placebo in Chemonaive Patients With Advanced NSCLC With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Study identification

NCT ID
NCT01221077
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Astellas Pharma Inc
Industry
Enrollment
88 participants

Conditions and interventions

Interventions

  • OSI-906 Drug
  • Erlotinib Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 7, 2011
Primary completion
Feb 28, 2013
Completion
Aug 31, 2014
Last update posted
Nov 17, 2025

2011 – 2014

United States locations

U.S. sites
13
U.S. states
9
U.S. cities
11
Facility City State ZIP Site status
University of California, San Diego/Moores Cancer Center La Jolla California 92093
H. Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612
Cleveland Clinic Florida Weston Florida 33331
Northwestern Memorial Hospital Chicago Illinois 60611
Rush University Medical Center Chicago Illinois 60612
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland 21231
Karmanos Cancer Institute Detroit Michigan 48201
Memorial Sloan Kettering Cancer Center New York New York 10021
Medical University of South Carolina Charleston South Carolina 29425
University of Tennessee Cancer Institute Memphis Tennessee 31804
Vanderbilt University Medical Center Nashville Tennessee 37232
Swedish Cancer Institute Seattle Washington 98104
Seattle Cancer Care Alliance University of Washington Seattle Washington 98109

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01221077, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 17, 2025 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01221077 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →