Non-Squamous Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGStandard chemotherapy
As prescribed--chemotherapy may be a)gemcitabine/cisplatin, b)vinorelbine + cisplatin/docetaxel + cisplatin or c)vinorelbine or docetaxel.
DRUGbevacizumab [Avastin]
15mg/kg iv or 7.5mg/kg on day 1, and subsequently once every 3 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* participating in, and meeting all inclusion/
Exclusion criteria
of, MO19390.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | Event driven |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival; response rates | Event driven |
| Adverse events | Throughout study |
Countries
Spain
Outcome results
None listed