An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
An Open Label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Docetaxel and Cisplatin on Progression-free Survival in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- stage IIIb or IV non-small cell lung cancer;
- chemotherapy-naive.
Exclusion Criteria:
- previous treatment for non-small cell lung cancer;
- previous malignant tumor within last 5 years, except for basal cell skin cancer or
preinvasive cervical cancer;
- major surgical procedure, open biopsy or significant traumatic injury within 28 days
prior to start of study;
- recent or current chronic treatment with aspirin (>325mg/day).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Ministry of Health
Study ID:
ML20081
NCT ID:
NCT00661778
Start Date:
July 2007
Completion Date:
July 2011
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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