Phase 3
Completed N=271
Efficacy Study of Avastin® With Pemetrexed +/- Carboplatin to Treat Elderly Patients With Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00976456 ↗Enrolled (actual)
271
Serious AEs
5.9%
Results posted
Mar 2016
Primary outcomePrimary: Progression Free Survival — 4.8; 6.8 months — p=0.0583
Summary
Multi-center, open, randomized (parallel) and comparative phase III.
Eligible patients will receive bevacizumab + chemotherapy for a minimum of 4 cycles followed by bevacizumab (+ pemetrexed, if appropriate) maintenance therapy until disease progression.
Arm A: Bevacizumab + pemetrexed
Arm B: Bevacizumab + pemetrexed + carboplatin
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
4.8; 6.8 | 0.0583 |
| SECONDARY Overall Survival |
11.6; 14.4 | 0.3869 |
Eligibility Criteria
Inclusion Criteria
- Stage IIIb and IV NSCLC, excluded squamous cell NSCLC
- Age ≥ 65 years
- ECOG 0-2
Exclusion Criteria
- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
- History of haemoptysis
- Evidence of tumour invading major blood vessels on imaging
- Radiotherapy within 28 days prior to enrolment
- Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
- Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
- Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
- Non-healing wound, active peptic ulcer or bone fracture
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
Data sourced from ClinicalTrials.gov (NCT00976456). 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.