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

Phase 3

Completed

• Conditions: Non-Small Cell Lung Cancer (NSCLC)
• Interventions: Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed; Drug: Eribulin

• Registration Number: NCT01454934
• Lead Sponsor: Eisai Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-19
• Study Start: 2011-12-09
• Primary Completion: 2014-05-30
• Study Completion: 2016-05-02
• Results First Submitted: 2017-01-11
• Results First Submitted QC: 2017-01-11
• Results First Posted: 2017-03-01
• Status Verified: 2017-08
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 540

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed	-
Arm A	Eribulin	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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 Outcome Measures

Name	Time	Method
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	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)	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.