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

Hoffmann-La Roche276 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

276

Conditions

Non-Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

Beijing, China

Beijing Cancer Hospital

Beijing, China

Beijing Hospital of Ministry of Health; Hematology

Beijing, China

General Hospital of Chinese PLA; Department of Hematology

Beijing, China

Beijing Chest Hospital; Oncology Department

Beijing, China

The Second Xiangya Hospital of Central South University

Changsha, China

West China Hospital, Sichuan University

Chengdu, China

Guangdong General Hospital

Guangzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

...and 7 more locations

Outcomes

Primary Outcomes

Progression-Free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0) Criteria

Time frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 20 months)

Secondary Outcomes

Overall Survival (OS)

Time frame: Baseline up to death (up to approximately 35 months)

Percentage of Participants Who are Alive at Year 1

Time frame: Year 1

Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed Using RECIST v1.0 Criteria