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

June 16, 2023 updated by: Eisai Inc.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia
    • Victoria
      • Frankston, Victoria, Australia
  • France
    • Bas Rhin
      • Strasbourg, Bas Rhin, France
    • Bouches-du-Rhone
      • Marseille Cedex 20, Bouches-du-Rhone, France
    • Bouches-duRhone
      • Marseille Cedex 9, Bouches-duRhone, France
    • Gironde
      • Bordeaux, Gironde, France
    • Haute Garonne
      • Toulouse Cedex 9, Haute Garonne, France
    • Haute Vienne
      • Limoges, Haute Vienne, France
    • Ille Et Vilaine
      • Rennes Cedex 9, Ille Et Vilaine, France
    • Loire Atlantique
      • Saint Herblain, Loire Atlantique, France
    • Nord
      • Lille, Nord, France
    • Paris
      • Paris Cedex 12, Paris, France
    • Rhone
      • Pierre Benite cedex, Rhone, France
    • Val De Marne
      • Villejuif cedex, Val De Marne, France
  • Germany
    • Bayern
      • Aschaffenburg, Bayern, Germany
      • Gauting, Bayern, Germany
      • Muenchen, Bayern, Germany
    • Nordrhein Westfalen
      • Essen, Nordrhein Westfalen, Germany
      • Koeln, Nordrhein Westfalen, Germany
      • Recklinghausen, Nordrhein Westfalen, Germany
    • Rheinland Pfalz
      • Mainz, Rheinland Pfalz, Germany
    • Sachsen Anhalt
      • Halle, Sachsen Anhalt, Germany
  • Hong Kong
      • Hong Kong, Hong Kong
  • Italy
      • Cremona, Italy
      • Milano, Italy
      • Siena, Italy
    • Lucca
      • Lido di Camaiore, Lucca, Italy
    • Milano
      • Monza, Milano, Italy
    • Pordenone
      • Aviano, Pordenone, Italy
  • Japan
      • Kitaadachi-gun, Japan
    • Aichi-Ken
      • Nagoya-shi, Aichi-Ken, Japan
    • Chiba-Ken
      • Kashiwa-shi, Chiba-Ken, Japan
    • Fukuoka-Ken
      • Fukuoka-shi, Fukuoka-Ken, Japan
    • Hiroshima-Ken
      • Hiroshima-shi, Hiroshima-Ken, Japan
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
    • Hygo-Ken
      • Kobe-shi, Hygo-Ken, Japan
    • Hyogo-ken
      • Akashi-shi, Hyogo-ken, Japan
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Japan
    • Nigata-Ken
      • Nigata-shi, Nigata-Ken, Japan
    • Okayama-Ken
      • Kurashiki-shi, Okayama-Ken, Japan
    • Osaka-Fu
      • Habinko-shi, Osaka-Fu, Japan
      • Osaka-shi, Osaka-Fu, Japan
      • Osakasayama-shi, Osaka-Fu, Japan
    • Shizuoka-Ken
      • Sunto-gun, Shizuoka-Ken, Japan
    • Tokyo-To
      • Koto-ku, Tokyo-To, Japan
    • Tokyo-to
      • Chuo-ku, Tokyo-to, Japan
    • Yamaguchi-Ken
      • Ube-shi, Yamaguchi-Ken, Japan
  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Suwon, Gyeonggi-do, Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of
  • Poland
      • Gdansk, Poland
      • Mrozy, Poland
      • Otwock, Poland
      • Sczedin, Poland
      • Warsazawa, Poland
  • Russian Federation
      • Barnaul, Russian Federation
      • Novosibirsk, Russian Federation
      • Saint Petersburg, Russian Federation
  • Singapore
      • Singapore, Singapore
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
    • Barcelona
      • Sabadell, Barcelona, Spain
      • Terrassa, Barcelona, Spain
    • Navarra
      • Pamplona, Navarra, Spain
  • Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Taipei City, Taiwan
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom
  • United States
    • California
      • Los Angeles, California, United States
      • Pleasant Hill, California, United States
      • San Diego, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Port Saint Lucie, Florida, United States
    • Illinois
      • Decatur, Illinois, United States
    • Michigan
      • Southfield, Michigan, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New York
      • Lake Success, New York, United States
    • Oregon
      • Portland, Oregon, United States
    • Washington
      • Spokane, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion:

Subjects must meet all of the following criteria to be included in this study:

  1. Histologically or cytologically confirmed diagnosis of NSCLC.
  2. Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy.
  3. Confirmation of the presence or absence of EGFR mutations prior to study enrolment in all subjects.
  4. Subjects must have received at least two prior regimens for advanced NSCLC, which should have included a platinum-based regimen and, in all subjects with tumors harbouring EGFR mutations, an EGFR TKI.
  5. Radiographic evidence of disease progression on, or after, the last anti-cancer regimen prior to study entry.
  6. Presence of measurable disease.
  7. ECOG performance status of 0, 1, or 2.
  8. Adequate bone marrow
  9. Adequate renal function.
  10. Adequate liver function.
  11. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception.
  12. Male subjects and their female partners who are of child-bearing potential must agree to use two forms of highly effective contraception.
  13. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
  14. Males or females aged at least 18 years (or any age greater than 18 years as determined by country legislation) at the time of informed consent.

Exclusion:

Subjects who meet any of the following criteria will be excluded from this study:

  1. Subjects who have received any anti-cancer therapy within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization.
  2. Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2.
  3. Subjects who have previously been treated, or participated in a study with eribulin, whether treated with eribulin or not. The TPC option must not include the same agent which the subject received in a prior regimen.
  4. Peripheral neuropathy more than CTCAE Grade 2.
  5. Significant cardiovascular impairment.
  6. Subjects with a high probability of Long QT Syndrome, or QTc interval >500 ms.
  7. Subjects with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy.
  8. Any serious concomitant illness.
  9. Known HIV positive, or have an infection requiring treatment.
  10. Any malignancy that required treatment, or has shown evidence of recurrence (except for NSCLC, non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in-situ) during the 5 years prior to study entry.
  11. Female subjects must not be pregnant, and must not be breastfeeding.
  12. Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the excipients of the eribulin formulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Drug: Eribulin
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
  • Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days
  • Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days
  • Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days
  • Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Randomization (Day 1) until date of death from any cause, or 37 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months
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.
Randomization (Day 1) to CR or PR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E7389-G000-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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