A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Placebo; Drug: bevacizumab [Avastin]; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806923

BO17704

Details and patient eligibility

About

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

Enrollment: 1,044 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
• adequate liver and kidney function;
• women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

Exclusion criteria

• prior chemotherapy or treatment with another systemic cancer therapy;
• surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
• brain metastasis or spinal cord compression;
• fertile men, and women of childbearing potential, not using adequate contraception;
• treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,044 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: bevacizumab [Avastin]

Drug: bevacizumab [Avastin]

2

Experimental group

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: bevacizumab [Avastin]

Drug: bevacizumab [Avastin]

3

Placebo Comparator group

Treatment:

Drug: Cisplatin

Drug: Placebo

Drug: Gemcitabine