Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Avastin (Bevacizumab) Versus Placebo in Combination With Carboplatin/Paclitaxel) in Patients 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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01364012
First received: May 27, 2011
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This randomized, double-blind, placebo-controlled study will evaluate the effica cy and safety of Avastin (bevacizumab) versus placebo in combination with carbop latin/paclitaxel in patients with advanced or recurrent non-squamous non-small c ell lung cancer who have not received prior chemotherapy for advanced disease. P atients will be randomized to receive either Avastin 15 mg/kg intravenously or p lacebo on Day 1 of each 3-week cycle, plus up to 6 cycles of carboplatin/paclita xel. Anticipated time on study treatment is until disease progression or unaccep table toxicity occurs. After progression, patients in the Avastin-arm may contin ue to receive Avastin in combination with approved second- and third-line treatm ent at the discretion of the investigator, up to the third progression.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: carboplatin
Drug: paclitaxel
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival (PFS), tumour assessments according to RECIST criteria [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
  • 1-year survival rate [ Time Frame: approximately 30 months ] [ Designated as safety issue: No ]
  • Overall response rate (ORR): complete response + partial response [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]
  • Correlation of baseline vascular endothelial growth factor (VEGF) plasma levels with clinical outcome (PFS/OS/ORR) [ Time Frame: approximately 48 months ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: May 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab [Avastin]
15 mg/kg intravenously (iv) on Day 1 of each 3-week cycle
Drug: carboplatin
AUC 6.0 iv on Day 1 of each 3-week cycle, up to 6 cycles
Drug: paclitaxel
175 mg/m2 iv on Day 1 of each 3-week cycle, up to 6 cycles
Active Comparator: B Drug: carboplatin
AUC 6.0 iv on Day 1 of each 3-week cycle, up to 6 cycles
Drug: paclitaxel
175 mg/m2 iv on Day 1 of each 3-week cycle, up to 6 cycles
Drug: placebo
15 mg iv on Day 1 of each 3-week cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Locally advanced (Stage IIIb not amenable for combined modality treatment), metastatic (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate haematological, renal and liver function

Exclusion Criteria:

  • Prior chemotherapy or treatment with another systemic anti-cancer agent for the current stage of the disease (IIIb, IV or recurrent)
  • Mixed non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
  • Evidence of tumour invading major blood vessels on imaging
  • CNS metastases, even if previously treated
  • History of haemoptysis 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 NSCLC 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364012

Locations
China
Beijing, China, 101149
Beijing, China, 100853
Beijing, China, 100071
Beijing, China, 100142
Beijing, China, 100730
Changsha, China, 410011
Chengdu, China, 610041
Guangzhou, China
Guangzhou, China, 510120
Hangzhou, China, 310016
Harbin, China, 150081
Jiangsu, China, 210009
Nanning, China, 530021
Shanghai, China, 200032
Shanghai, China, 200433
Shanghai, China, 200030
Shantou, China, 515041
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01364012     History of Changes
Other Study ID Numbers: YO25404
Study First Received: May 27, 2011
Last Updated: November 24, 2014
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Bevacizumab
Carboplatin
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014