A Study of Avastin (Bevacizumab) in Combination With Platinum-Containing Chemotherapy in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.

Roche

Status and phase: Completed; Phase 4

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Bevacizumab [Avastin]; Drug: Platinum-based chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00451906

MO19390

Details and patient eligibility

About

This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

Enrollment: 2,252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• histologically or cytologically documented inoperable, locally advanced ( stage III), metastatic (stage IV) or recurrent NSCLC other than squamous cell (tumors of mixed histology should be categorized by the predominant cell type);
• ECOG PS status 0-2;
• life expectancy >= 12weeks;
• adequate renal, liver and hematological function.

Exclusion criteria

• mixed, non-small and small cell tumors, or mixed adenosquamous carcinomas with a predominant squamous component;
• hemoptysis (>=1/2 teaspoon of bright red blood) in previous 3 months;
• evidence of tumor invading major blood vessels on imaging;
• evidence of CNS metastases, even if previously treated.
• major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment, or anticipation of need for major surgery during study treatment;
• prior chemotherapy for stage IIIb/IV disease.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,252 participants in 1 patient group

Bevacizumab + Chemotherapy

Experimental group

Description:

Participants with advanced or recurrent NSCLC will be administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator's choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab will be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy.

Treatment:

Drug: Platinum-based chemotherapy

Drug: Bevacizumab [Avastin]