Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments erlotinib, placebo
Phase phase 3
Target EGFR
Sponsor OSI Pharmaceuticals
Start date September 2006
End date April 2013
Trial size 1252 participants
Trial identifier NCT00373425, 2005-001747-29, OSI-774-302

Summary

This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
erlotinib OSI-774
150 mg tablet
(Placebo Comparator)
Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
placebo
Placebo tablet

Primary Outcomes

Measure
Disease Free Survival (DFS)
time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (maximum time on follow-up was 64 months).

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (maximum time on follow-up was 64 months)
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (maximum time on follow-up was 64 months).
Overall Survival in Participants With EGFR Mutation - Positive Tumors
time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter (maximum time on follow-up was 64 months)
Number of Participants With Adverse Events (AEs)
time frame: From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo.

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests - Patients may have up to 4 cycles of chemotherapy after surgery - Complete removal of the tumor by surgery - Able to start drug under the following timelines: - 6 months from the day of surgery for patients who get chemotherapy - 3 months from the day of surgery for those who do not get chemotherapy - Confirmed diagnosis of Stage IB-IIIA NSCLC - Patients must be accessible for follow-up visits Exclusion Criteria: - History of prior radiotherapy for NSCLC either before or after surgery - History of heart disease or uncontrolled heart arrhythmias within the previous year - History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug - History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years - Patients who have received chemotherapy for NSCLC before surgery - Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.

Additional Information

Official title A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (Erlotinib) Following Complete Tumor Resection With or Without Adjuvant Chemotherapy in Patients With Stage IB-IIIA Non-small Cell Lung Carcinoma Who Have EGFR-positive Tumors
Description After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.