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
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
1 other identifier
interventional
276
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 nonsmall-cell-lung-cancer
Started May 2011
Typical duration for phase_3 nonsmall-cell-lung-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2011
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2017
CompletedFebruary 5, 2018
February 1, 2018
1.7 years
May 27, 2011
February 1, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0) Criteria
Baseline up to death or disease progression, whichever occurs first (up to approximately 20 months)
Secondary Outcomes (11)
Overall Survival (OS)
Baseline up to death (up to approximately 35 months)
Percentage of Participants Who are Alive at 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
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
Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months)
Percentage of Participants With Adverse Events
From baseline up to approximately 35 months
- +6 more secondary outcomes
Study Arms (2)
Bevacizumab + Paclitaxel/Carboplatin
EXPERIMENTALParticipants 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.
Placebo + Paclitaxel/Carboplatin
ACTIVE COMPARATORParticipants 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.
Interventions
Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
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.
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.
Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, 100071, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Hospital of Ministry of Health; Hematology
Beijing, 100730, China
General Hospital of Chinese PLA; Department of Hematology
Beijing, 100853, China
Beijing Chest Hospital; Oncology Department
Beijing, 101149, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Guangdong General Hospital
Guangzhou, 510080, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Jiangsu Cancer Hospital
Nanjing, 210009, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530021, China
Shanghai chest hospital
Shanghai, 200030, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Cancer Hospital of Shantou University Medical College
Shantou, 515041, China
Related Publications (1)
Zhou C, Wu YL, Chen G, Liu X, Zhu Y, Lu S, Feng J, He J, Han B, Wang J, Jiang G, Hu C, Zhang H, Cheng G, Song X, Lu Y, Pan H, Zheng W, Yin AY. BEYOND: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study of First-Line Carboplatin/Paclitaxel Plus Bevacizumab or Placebo in Chinese Patients With Advanced or Recurrent Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2015 Jul 1;33(19):2197-204. doi: 10.1200/JCO.2014.59.4424. Epub 2015 May 26.
PMID: 26014294DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2011
First Posted
June 2, 2011
Study Start
May 23, 2011
Primary Completion
January 27, 2013
Study Completion
August 17, 2017
Last Updated
February 5, 2018
Record last verified: 2018-02