Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer
Both
Non-Small Cell Lung Cancer
Trial Information
Open-label Study of Bevacizumab Maintenance Therapy (AVASTIN®) With or Without Pemetrexed After First-line Chemotherapy With Bevacizumab-cisplatin-pemetrexed in Patients With Advanced, Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- adults >/=18 years of age
- inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC
- at least 1 measurable lesion meeting RECIST criteria
- ECOG performance status 0-2
- adequate hematological, liver and renal function
Exclusion Criteria:
- prior chemotherapy or treatment with another systemic anti-cancer agent
- malignancies other than NSCLC within 5 years prior to randomization, except for
adequately treated cracinoma in situ of the cervix, basal or squameous cell skin
cancer, localized prostate cancer or DCIS
- evidence of tumour invading major blood vessels
- current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or
thrombolytic agents for therapeutic purposes
- history of haemoptysis >/=grade 2
- clinically significant cardiovascular disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
tumour assessment before cycle 3, at 2nd cycle of maintenance therapy and every 9 weeks thereafter
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Russia: Ministry of Health of the Russian Federation
Study ID:
MO22089
NCT ID:
NCT00961415
Start Date:
July 2009
Completion Date:
October 2012
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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