A Genetic Substudy Associated With the Avastin (Bevacizumab) Study MO19390 in Patients With Advanced or Recurrent Non-Squamous Cell Lung Cancer.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Interventions
- Drug: Standard chemotherapyDrug: bevacizumab [Avastin]
- Registration Number
- NCT00642824
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm genetic substudy of MO19390 will test the hypothesis that there is a positive relationship between mRNA BRCAI levels and the response to different chemotherapy combinations plus Avastin. A subset of patients participating in MO19390, and receiving Avastin 15mg/kg iv on day 1 and subsequently once every 3 weeks, will undergo BRCAI mRNA expression determination. Depending on the BRCAI mRNA level (low, medium or high) they will receive a different chemotherapy regimen in combination with Avastin: a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- participating in, and meeting all inclusion/exclusion criteria of, MO19390.
- not meeting the inclusion/exclusion criteria of MO19390.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Standard chemotherapy - 1 bevacizumab [Avastin] -
- Primary Outcome Measures
Name Time Method Progression-free survival Event driven
- Secondary Outcome Measures
Name Time Method Overall survival; response rates Event driven Adverse events Throughout study