NCT00445848

S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer

A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who have never smoked.

Detailed description

OBJECTIVES: Primary * Assess overall survival of patients with stage IIIB or IV primary non-small cell lung adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and bevacizumab. Secondary * Assess progression-free survival of patients treated with this regimen. * Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset of patients with measurable disease treated with this regimen. * Evaluate the frequency and severity of toxicities associated with this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral erlotinib hydrochloride daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab
DRUG	erlotinib hydrochloride

Timeline

• Start date: 2007-07-01
• Primary completion: 2013-08-01
• Completion: 2014-01-01
• First posted: 2007-03-09
• Last updated: 2020-03-05
• Results posted: 2016-09-07

Locations

153 sites across 1 country: United States