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

February 1, 2018 updated by: Hoffmann-La Roche

A Randomized, Double-blinded, Placebo-controlled, Multicenter Phase III Study Comparing Bevacizumab Plus Carboplatin/Paclitaxel Versus Placebo Plus Carboplatin/Paclitaxel in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy For Advanced Disease

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100071
        • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
      • Beijing, China, 101149
        • Beijing Chest Hospital; Oncology Department
      • Beijing, China, 100853
        • General Hospital of Chinese PLA; Department of Hematology
      • Beijing, China, 100730
        • Beijing Hospital of Ministry of Health; Hematology
      • Changsha, China, 410011
        • The Second Xiangya Hospital of Central South University
      • Chengdu, China, 610041
        • West China Hospital, Sichuan University
      • Guangzhou, China, 510080
        • Guangdong General Hospital
      • Guangzhou, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University
      • Hangzhou, China, 310016
        • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Nanjing, China, 210009
        • Jiangsu Cancer Hospital
      • Nanning, China, 530021
        • Guangxi Cancer Hospital of Guangxi Medical University
      • Shanghai, China, 200030
        • Shanghai Chest Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital
      • Shantou, China, 515041
        • Cancer Hospital of Shantou University Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab + Paclitaxel/Carboplatin
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.
Drug: Bevacizumab
Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Other Names:
  • Avastin
Drug: Carboplatin
Carboplatin will be administered at area under the plasma concentration-time curve (AUC) 6.0 IV on Day 1 of each 3-week cycle, up to 6 cycles.
Drug: Paclitaxel
Paclitaxel will be administered at 175 milligrams per square meter (mg/m^2) IV on Day 1 of each 3-week cycle, up to 6 cycles.
Active Comparator: Placebo + Paclitaxel/Carboplatin
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.
Drug: Carboplatin
Carboplatin will be administered at area under the plasma concentration-time curve (AUC) 6.0 IV on Day 1 of each 3-week cycle, up to 6 cycles.
Drug: Paclitaxel
Paclitaxel will be administered at 175 milligrams per square meter (mg/m^2) IV on Day 1 of each 3-week cycle, up to 6 cycles.
Drug: Placebo
Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline up to death or disease progression, whichever occurs first (up to approximately 20 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Baseline up to death (up to approximately 35 months)
Baseline up to death (up to approximately 35 months)
Percentage of Participants Who are Alive at Year 1
Time Frame: Year 1
Year 1
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed Using RECIST v1.0 Criteria
Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Duration of Response as Assessed Using RECIST v1.0 Criteria
Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Percentage of Participants With Adverse Events
Time Frame: From baseline up to approximately 35 months
From baseline up to approximately 35 months
PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor-A (VEGF-A) High/Low Level Expression at Baseline
Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
PFS as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) High/Low Level Expression at Baseline
Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline
Time Frame: Baseline up to death (up to approximately 35 months)
Baseline up to death (up to approximately 35 months)
OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline
Time Frame: Baseline up to death (up to approximately 35 months)
Baseline up to death (up to approximately 35 months)
Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline
Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Percentage of Participants With Objective Response of CR or PR as Assessed Using RECIST v1.0 Criteria in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline
Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2011

Primary Completion (Actual)

January 27, 2013

Study Completion (Actual)

August 17, 2017

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 2, 2011

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YO25404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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