A Study of Avastin (Bevacizumab) in Combination With Standard of Care Treatment in Patients With Lung Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

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

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):

Gridelli C, Bennouna J, de Castro J, Dingemans AM, Griesinger F, Grossi F, Rossi A, Thatcher N, Wong EK, Langer C. Randomized phase IIIb trial evaluating the continuation of bevacizumab beyond disease progression in patients with advanced non-squamous non-small-cell lung cancer after first-line treatment with bevacizumab plus platinum-based chemotherapy: treatment rationale and protocol dynamics of the AvaALL (MO22097) trial. Clin Lung Cancer. 2011 Nov;12(6):407-11. Epub 2011 Jun 25.

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:	June 11, 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 June 17, 2013