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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364012
First Posted: June 2, 2011
Last Update Posted: July 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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 Intervention Phase
Non-Small Cell Lung Cancer Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

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) ]

Enrollment: 276
Actual Study Start Date: May 23, 2011
Estimated Study Completion Date: August 30, 2017
Estimated Primary Completion Date: August 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, China, 100071
Beijing Cancer Hospital
Beijing, China, 100142
Beijing Hospital of Ministry of Health; Hematology
Beijing, China, 100730
General Hospital of Chinese PLA; Department of Hematology
Beijing, China, 100853
Beijing Chest Hospital; Oncology Department
Beijing, China, 101149
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
West China Hospital, Sichuan University
Chengdu, China, 610041
Guangdong General Hospital
Guangzhou City, China, 510080
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China, 510120
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China, 310016
Harbin Medical University Cancer Hospital
Harbin, China, 150081
Jiangsu Cancer Hospital
Nanjing, China, 210009
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China, 530021
Shanghai chest hospital
Shanghai, China, 200030
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Cancer Hospital of Shantou University Medical College
Shantou, China, 515041
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01364012     History of Changes
Other Study ID Numbers: YO25404
First Submitted: May 27, 2011
First Posted: June 2, 2011
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors