Phase 2
Completed N=91
A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer With Asymptomatic Untreated Brain Metastasis
Source: ClinicalTrials.gov NCT00800202 ↗Enrolled (actual)
91
Serious AEs
37.4%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months — 56.5; 57.2 percentage of participants
Summary
This study will assess the efficacy and safety of Avastin combined with first li ne paclitaxel-carboplatin (cohort 1) or second line Tarceva (cohort 2) in patien ts with non-squamous non-small cell lung cancer with asymptomatic untreated brai n metastasis. Two cohorts of patients will be studied; the first will receive Av astin 15mg/kg iv every 3 weeks combined with first line paclitaxel 200mg/m2 iv p lus carboplatin AUC6 iv every 3 weeks for a maximum of 6 cycles, and the second cohort will receive Avastin 15mg/kg iv every 3 weeks combined with second line T arceva 150mg/kg po.The anticipated time on study treatment is until disease prog ression, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months |
56.5; 57.2 | — |
| PRIMARY Percentage of Participants With Disease Progression or Death |
89.6; 91.7 | — |
| PRIMARY Time to Disease Progression or Death |
6.7; 6.3 | — |
| SECONDARY Percentage of Participants Who Died |
83.6; 91.7 | — |
| SECONDARY Probability of Being Alive at 12 and 18 Months |
64.2; 50.0; 43.3; 41.7 | — |
| SECONDARY Time to Death |
16.0; 12.0 | — |
| SECONDARY Percentage of Participants Achieving a Best Overall Response of Complete Response or Partial Response as Assessed by the Investigator Using RECIST |
62.7; 12.5 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- stage IV non-squamous non-small cell lung cancer;
- asymptomatic, untreated brain metastasis;
- ECOG performance status 0-1.
Exclusion Criteria
- previous treatment for brain metastasis;
- history of migraine or epilepsy;
- previous treatment with angiogenesis inhibitors;
- for cohort 2, previous first line treatment with Avastin or Tarceva;
- current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agent for therapeutic purposes.
Data sourced from ClinicalTrials.gov (NCT00800202). 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.