Trial record 1 of 1 for:    MO22097
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A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01351415
First received: May 9, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

This open-label, randomized, multicenter study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with standard of care treatment in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Patients will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with Avastin plus a platinum doublet-containing therapy and a minimum of two cycles of Avastin maintenance treatment prior to PD. Patients will be randomly assigned to one of two treatment arms to receive either Avastin plus standard of care treatment or standard of care treatment alone.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: bevacizumab [Avastin]
Drug: Standard of care treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First (1st)-Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: bevacizumab [Avastin]
7.5 or 15 mg/kg intravenously on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
Drug: Standard of care treatment
Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent
Active Comparator: B Drug: Standard of care treatment
Investigator's choice of standard of care treatment on Day 1 every 21 days until unacceptable toxicity or withdrawal of consent

  Eligibility

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

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
  • Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment 4-6 cycles of Avastin plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Avastin (monotherapy) maintenance treatment prior to first progression of disease
  • No treatment interruption of Avastin treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
  • Randomization within 4 weeks of progression of disease
  • At least one unidimensionally measurable lesion meeting RECIST criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

  • Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
  • History of hemoptysis >/=grade 2 within 3 months of randomization
  • Major cardiac disease
  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: NCT01351415

Contacts
Contact: Reference Study ID Number: MO22097 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 176 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01351415     History of Changes
Other Study ID Numbers: MO22097
Study First Received: May 9, 2011
Last Updated: August 13, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014