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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| ClinicalTrials.gov Identifier: NCT01364012 |
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Recruitment Status :
Completed
First Posted : June 2, 2011
Last Update Posted : February 5, 2018
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 276 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 23, 2011 |
| Actual Primary Completion Date : | January 27, 2013 |
| Actual Study Completion Date : | August 17, 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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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 Name: 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. |
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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.
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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. |
Primary Outcome Measures :
- 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 Measures :
- 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 [ Time Frame: 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) ]
- Percentage of Participants With Adverse Events [ Time Frame: 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) ]
- 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) ]
- OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline [ Time Frame: 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) ]
- 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) ]
- 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) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364012
Locations
Show 17 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01364012 |
| Other Study ID Numbers: |
YO25404 |
| First Posted: | June 2, 2011 Key Record Dates |
| Last Update Posted: | February 5, 2018 |
| Last Verified: | February 2018 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Bevacizumab Carboplatin |
Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |