A Randomized, Open-label, Multicenter, Phase 3 Study to Compare the Efficacy and Safety of Eribulin With Treatment of Physician's Choice in Subjects With Advanced Non-Small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 540
- Primary Endpoint
- Overall Survival (OS)
Study Overview
Brief Summary
This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm A
Intervention: Eribulin (Drug)
Arm B
Intervention: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Randomization (Day 1) until date of death from any cause, or 37 months
The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata.
Secondary Outcomes
- Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)(Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months)
- Objective Response Rate (ORR)(Randomization (Day 1) to CR or PR)