Phase 3
Completed N=376
AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00961415 ↗Enrolled (actual)
376
Serious AEs
37.0%
Results posted
Feb 2016
Primary outcomePrimary: Progression Free Survival During Maintenance Treatment Phase — 6.6; 10.2 Months — p=<0.001
Summary
This open-label study will assess the efficacy and safety of Avastin with or without pemetrexed as maintenance therapy in patients with advanced, metastatic or recurrent non-small cell lung cancer. In Part 1, patients will receive 4 cycles of treatment with Avastin (7.5mg/kg iv) plus cisplatin (75mg/m2 iv) plus pemetrexed (500mg/m2 iv) on day 1 of each 3-week cycle. In Part 2, patients responding to treatment will be randomized to receive further treatment cycles of Avastin (7.5mg/kg iv every 3 weeks) with or without pemetrexed (500mg/m2 iv every 3 weeks). Anticipated time on study treatment is until disease progression. Target sample size is <500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival During Maintenance Treatment Phase |
6.6; 10.2 | <0.001 sig |
| SECONDARY Overall Survival During Maintenance Treatment Phase |
15.7; NA | 0.230 |
| SECONDARY Best Overall Response Rate During Maintenance Treatment Phase |
50; 55.5; 50; 44.5 | — |
| SECONDARY Duration of Response During Maintenance Treatment Phase |
5.7; 9.2 | 0.006 sig |
| SECONDARY Duration of Disease Control During Maintenance Treatment Phase |
4.9; 7.8 | <0.001 sig |
| SECONDARY Incidence of Adverse Events and Serious Adverse Event |
116; 123; 119; 26; 42; 70 | — |
| SECONDARY Number of Participants With Marked Laboratory Abnormalities |
18; 26; 8; 18; 26; 8 | — |
| SECONDARY Quality of Life |
57.9; 59.7; 74.8; 79.4; 68.4; 71.1 | — |
Eligibility Criteria
Inclusion Criteria
- adults >/=18 years of age
- inoperable, locally advanced, metastatic or recurrent non-squamous non-small cell lung cancer (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 carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
- evidence of tumor 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
Data sourced from ClinicalTrials.gov (NCT00961415). 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.