A Study of Bevacizumab Versus Placebo in Combination With Carboplatin/Paclitaxel in Participants With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Previous Chemotherapy

Roche

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Paclitaxel; Drug: Placebo; Drug: Carboplatin; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01364012

YO25404

Details and patient eligibility

About

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of bevacizumab (Avastin) versus placebo in combination with carboplatin/paclitaxel in participants with advanced or recurrent non-squamous non-small cell lung cancer who have not received prior chemotherapy for advanced disease. Participants will be randomized to receive either bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) or placebo on Day 1 of each 3 week cycle, plus up to 6 cycles of carboplatin/paclitaxel. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. After progression, participants in the bevacizumab arm may continue to receive bevacizumab in combination with approved second- and third-line treatment at the discretion of the investigator, up to the third progression.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Adequate hematological, renal and liver function

Exclusion criteria

• Prior chemotherapy or treatment with another systemic anti-cancer agent for the treatment of the participant's current stage of the disease (Stage IIIb, IV or recurrent disease)
• Mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
• Evidence of tumor invading major blood vessels on imaging
• Central nervous system (CNS) metastases, even if previously treated
• History of hemoptysis in the 3 months prior to enrollment
• History or evidence of inherited bleeding diathesis or coagulopathy
• Uncontrolled hypertension and/or history of hypertensive crisis or hypertensive encephalopathy
• Clinically significant cardiovascular or vascular disease
• Malignancies other than non-small cell lung cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or localized prostate cancer or ductal carcinoma in situ treated surgically with curative intent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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276 participants in 2 patient groups

Bevacizumab + Paclitaxel/Carboplatin

Experimental group

Description:

Participants will receive bevacizumab on Day 1 of each 3-week cycle in combination with paclitaxel and carboplatin for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive bevacizumab on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.

Treatment:

Drug: Carboplatin

Drug: Bevacizumab

Drug: Paclitaxel

Placebo + Paclitaxel/Carboplatin

Active Comparator group

Description:

Participants will receive bevacizumab matching placebo on Day 1 of each 3-week cycle in combination with paclitaxel and carboplatin for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive bevacizumab matching placebo on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.

Treatment:

Drug: Carboplatin

Drug: Placebo

Drug: Paclitaxel