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
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|ClinicalTrials.gov Identifier: NCT01454934|
Recruitment Status : Completed
First Posted : October 19, 2011
Results First Posted : March 1, 2017
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer (NSCLC)||Drug: Eribulin Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||December 9, 2011|
|Actual Primary Completion Date :||May 30, 2014|
|Actual Study Completion Date :||May 2, 2016|
|Experimental: Arm A||
Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
|Active Comparator: Arm B||
Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
- 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.
- Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months ]PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin mesylate and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance.
- Objective Response Rate (ORR) [ Time Frame: Randomization (Day 1) to CR or PR ]The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01454934