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Completed

NCT Number: NCT01364012

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 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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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Avastin

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.

Primary outcomes

  1. 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 outcomes

  1. Overall Survival (OS)

    Time frame: Baseline up to death (up to approximately 35 months)

  2. Percentage of Participants Who are Alive at Year 1

    Time frame: Year 1

  3. 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)

  4. 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)

  5. Percentage of Participants With Adverse Events

    Time frame: From baseline up to approximately 35 months

  6. 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)

  7. 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)

  8. OS in Subgroups Defined by VEGF-A High/Low Level Expression at Baseline

    Time frame: Baseline up to death (up to approximately 35 months)

  9. OS in Subgroups Defined by VEGFR-2 High/Low Level Expression at Baseline

    Time frame: Baseline up to death (up to approximately 35 months)

  10. 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)

  11. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Jun 2, 2011
Registry last updated
Feb 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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