Back to resultsA 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
Primary Purpose
Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Bevacizumab
Carboplatin
Paclitaxel
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer
Eligibility Criteria
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
Sites / Locations
- The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
- Beijing Cancer Hospital
- Beijing Hospital of Ministry of Health; Hematology
- General Hospital of Chinese PLA; Department of Hematology
- Beijing Chest Hospital; Oncology Department
- The Second Xiangya Hospital of Central South University
- West China Hospital, Sichuan University
- Guangdong General Hospital
- The First Affiliated Hospital of Guangzhou Medical University
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
- Harbin Medical University Cancer Hospital
- Jiangsu Cancer Hospital
- Guangxi Cancer Hospital of Guangxi Medical University
- Shanghai chest hospital
- Fudan University Shanghai Cancer Center
- Shanghai Pulmonary Hospital
- Cancer Hospital of Shantou University Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bevacizumab + Paclitaxel/Carboplatin
Placebo + Paclitaxel/Carboplatin
Arm 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.
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.
Outcomes
Primary Outcome Measures
Progression-Free Survival (PFS) as Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0) Criteria
Secondary Outcome Measures
Overall Survival (OS)
Percentage of Participants Who are Alive at Year 1
Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed Using RECIST v1.0 Criteria
Duration of Response as Assessed Using RECIST v1.0 Criteria
Percentage of Participants With Adverse Events
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
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
OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline
OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01364012
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2011 (Actual)
Primary Completion Date
January 27, 2013 (Actual)
Study Completion Date
August 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab + Paclitaxel/Carboplatin
Arm Type
Experimental
Arm 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.
Arm Title
Placebo + Paclitaxel/Carboplatin
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Baseline up to death (up to approximately 35 months)
Title
Percentage of Participants Who are Alive at Year 1
Time Frame
Year 1
Title
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)
Title
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)
Title
Percentage of Participants With Adverse Events
Time Frame
From baseline up to approximately 35 months
Title
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)
Title
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)
Title
OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline
Time Frame
Baseline up to death (up to approximately 35 months)
Title
OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline
Time Frame
Baseline up to death (up to approximately 35 months)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Hospital of Ministry of Health; Hematology
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
General Hospital of Chinese PLA; Department of Hematology
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Beijing Chest Hospital; Oncology Department
City
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Guangxi Cancer Hospital of Guangxi Medical University
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Shanghai chest hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
ZIP/Postal Code
515041
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26014294
Citation
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.
Results Reference
derived
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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
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