Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase 3

Completed

• Conditions: Lung Cancer
• Interventions: Drug: erlotinib hydrochloride; Drug: Matched placebo

• Registration Number: NCT00275132
• Lead Sponsor: University College, London

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

* Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.

Secondary

* Compare progression-free survival and response rate.

* Compare toxicity.

* Compare the quality of life.

* Compare cost-effectiveness.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral erlotinib once daily for up to 24 months.

* Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-01-10
• Study First Submitted QC: 2006-01-10
• Study First Posted: 2006-01-11
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2011-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erlotinib	erlotinib hydrochloride	Tarceva (OSI-774, erlotinib) PO 150mg daily
Matched placebo	Matched placebo	Matched placebo PO daily

Primary Outcome Measures

Name	Time	Method
Overall survival	between date of randomisation and date of death from any cause

Secondary Outcome Measures

Name	Time	Method
Progression free survival	from the date of randomisation to the date of first clinical evidence of progressive disease, or death.
Adverse events/Toxicity	during and for 28 days following Tarceva/placebo treatment
Quality of life	between randomisation and 8 weeks.	QL will be measured using the patient-completed EORTC-QLQ C30 and lung cancer module (LC 14). The primary QL outcome measures will be changes in overall QL and the five most commonly reported lung cancer symptoms (fatigue, breathlessness, cough, emotional functioning and pain).
Cost-effectiveness	from date of randomisation to death	Effectiveness will be estimated in terms of quality-adjusted life years. Mean survival will be calculated on the basis of observed mortality (i.e. a within-trial estimate) and by extrapolating the survival curves if some patients remain alive at the end of the trial.

Trial Locations

Locations (1)

London Lung Cancer Group; 🇬🇧 London, England, United Kingdom