TriangleNCT00806923 · CITED IN SOURCE DOCUMENTS
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2016-11-02
This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * adult patients, \>=18 years of age; * documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC; * adequate liver and kidney function; * women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment. Exclusion Criteria: * prior chemotherapy or treatment with another systemic cancer therapy; * surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment; * brain metastasis or spinal cord compression; * fertile men, and women of childbearing potential, not using adequate contraception; * treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Cisplatin
- Drug: Gemcitabine
- Drug: bevacizumab [Avastin]
- label
- 1
- type
- EXPERIMENTAL
- intervention Names
- Drug: Cisplatin
- Drug: Gemcitabine
- Drug: bevacizumab [Avastin]
- label
- 2
- type
- EXPERIMENTAL
- intervention Names
- Drug: Cisplatin
- Drug: Gemcitabine
- Drug: Placebo
- label
- 3
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- 1
- 2
- 3
- description
- 80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles
- name
- Cisplatin
- type
- DRUG
- arm Group Labels
- 1
- 2
- 3
- description
- 1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles
- name
- Gemcitabine
- type
- DRUG
- arm Group Labels
- 3
- description
- iv on day 1 of each 3 week cycle until disease progression
- name
- Placebo
- type
- DRUG
- arm Group Labels
- 1
- description
- 15mg/kg 1v on day 1 of each 3 week cycle until disease progression
- name
- bevacizumab [Avastin]
- type
- DRUG
- arm Group Labels
- 2
- description
- 7.5 mg/kg iv on day 1 of each 3 week cycle until disease progression
- name
- bevacizumab [Avastin]
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1044
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Progression-free survival
- time Frame
- Event driven
- secondary Outcomes
- measure
- Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.
- time Frame
- Event driven
- measure
- Safety:AEs, laboratory tests, SAEs, coagulation parameters
- time Frame
- Throughout study
Full study description
- brief Summary
- This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.
Source references
- references
- citation
- Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.
- pmid
- 21245868
- type
- DERIVED
- citation
- Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.
- pmid
- 20978447
- type
- DERIVED
- citation
- Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.
- pmid
- 20150572
- type
- DERIVED
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Preserved source evidence · Not medical advice