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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab + Paclitaxel/Carboplatin | Experimental | 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. |
|
| Placebo + Paclitaxel/Carboplatin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA) | Beijing | 100071 | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26014294 | Derived | 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. |
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|
| Carboplatin | Drug | 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 | Drug | 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. |
|
| Placebo | Drug | Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity. |
|
| 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 |
| 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 | 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 | 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 | Baseline up to death (up to approximately 35 months) |
| OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline | 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 | 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 | Baseline up to death or disease progression, whichever occurs first (up to approximately 35 months) |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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