Phase 2
Completed N=50
A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00661778 ↗Enrolled (actual)
50
Serious AEs
53.1%
Results posted
Jul 2014
Primary outcomePrimary: Progression-free Survival — 8.95 Months
Summary
This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m^2, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
8.95 | — |
| SECONDARY Percentage of Participants With an Objective Response |
67.39 | — |
| SECONDARY Duration of the Objective Response |
— | — |
| SECONDARY Overall Survival |
12.74 | — |
| SECONDARY 1-year Survival |
53.46 | — |
Eligibility Criteria
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 (> 325 mg/day).
Data sourced from ClinicalTrials.gov (NCT00661778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.