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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: erlotinib hydrochloride
* Drug: Matched placebo


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Advanced disease (stage IIIB or IV) Diagnosis within 62 days prior to randomization Not suitable for first-line chemotherapy, as defined by the following criteria*: ECOG performance status 2-3 ECOG performance status 0-1 AND creatinine clearance < 60 mL/min NOTE: *These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis No symptomatic brain metastases PATIENT CHARACTERISTICS: Estimated life expectancy of at least 8 weeks Able to take oral medication Not pregnant or nursing Fertile patients must use effective contraception No severe uncontrolled infection No unstable angina No myocardial infarction within the past month No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) No acute renal failure Bilirubin < 2 times upper limit of normal (ULN) Transaminases < 2 times ULN (5 times ULN if liver metastases are present) Creatinine < 5 times ULN No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications No other prior or current malignant disease likely to interfere with study treatment or comparisons PRIOR CONCURRENT THERAPY: No prior chemotherapy No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab) No prior palliative radiotherapy Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks No concurrent cyclooxygenase-2 inhibitors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erlotinib<br>Tarceva (OSI-774, erlotinib) PO 150mg daily | Drug: erlotinib hydrochloride<br>* Tarceva (OSI-774, erlotinib) PO 150 mg daily<br>* Other names: Tarceva;|
| Placebo Comparator: Matched placebo<br>Matched placebo PO daily | Drug: Matched placebo<br>* Matched placebo PO daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | between date of randomisation and date of death from any cause | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | between randomisation and 8 weeks. | 
| Cost-effectiveness | 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. | from date of randomisation to death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer