Phase 2
Completed N=86
A Study of Avastin (Bevacizumab) in Combination With Gemcitabine With or Without Cisplatin in First-Line Treatment of Elderly Patients With Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01077713 ↗Enrolled (actual)
86
Serious AEs
32.5%
Results posted
Oct 2015
Primary outcomePrimary: Percentage of Participants Alive and Without Progressive Disease at Month 6 — 25.6; 30.0 percentage of participants
Summary
This 2 arm study will evaluate the efficacy and safety of Avastin + gemcitabine, and Avastin + gemcitabine + attenuated doses of cisplatin, as first line treatment in elderly patients with non-squamous non-small cell lung cancer. Patients will be randomised to receive either Avastin 7.5mg/kg iv on day 1 + gemcitabine 1200mg/m2 on days 1-8 of each 3 week cycle, or Avastin 7.5mg/kg iv on day 1 + cisplatin 60mg/m2 on day 1 + gemcitabine 1000mg/m2 on days 1-8 of each 3 week cycle. After 6 cycles of combination therapy, all patients will continue to receive Avastin monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Alive and Without Progressive Disease at Month 6 |
25.6; 30.0 | — |
| SECONDARY Percentage of Participants With Disease Progression or Death |
86.0; 90.0 | — |
| SECONDARY Progression Free Survival (PFS) |
4.33; 6.82 | — |
| SECONDARY Percentage of Participants Alive at 12 Months After Randomization |
37.2; 47.5 | — |
| SECONDARY Percentage of Participants Who Died |
69.8; 72.5 | — |
| SECONDARY Overall Survival (OS) |
5.66; 12.0 | — |
| SECONDARY Percentage of Participants by Best Overall Response |
0.0; 0.0; 14.0; 35.0; 39.5; 37.5 | — |
| SECONDARY Percentage of Participants With an Objective Response |
11.6; 27.5; 9.3; 15.0; 4.7; 10.0 | — |
| SECONDARY Percentage of Participants With Disease Control |
53.5; 67.5; 27.9; 37.5; 25.6; 30.0 | — |
| SECONDARY Duration of Response (DoR) |
5.23; 5.97 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=70 years of age;
- inoperable, locally advanced, metastatic non-squamous non-small cell lung cancer;
- >=1 measurable lesion;
- ECOG performance status 0-1.
Exclusion Criteria
- neoadjuvant/adjuvant chemotherapy within 6 months prior to enrollment;
- radical radiotherapy with curative intent within 28 days prior to enrollment;
- history of >=grade 2 hemoptysis in 3 months prior to enrollment;
- evidence of CNS metastases;
- current or recent (within 10 days of first dose of Avastin)use of aspirin (>325 mg/day)or full dose anticoagulants or thrombolytic agents for therapeutic purposes.
Data sourced from ClinicalTrials.gov (NCT01077713). 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.