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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

This study has been completed.
Information provided by (Responsible Party):
Eisai Inc. Identifier:
First received: October 13, 2011
Last updated: June 22, 2016
Last verified: June 2016
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.

Condition Intervention Phase
Non-Small Cell Lung Cancer (NSCLC)
Drug: Eribulin
Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Evaluation of Overall Survival [ Time Frame: From randomization until 37 months ] [ Designated as safety issue: No ]
    OS, measured from the date of randomization until date of death from any cause. In absence of confirmation of death, subjects will be censored either at the date that the subject was last known to be alive or the date of study cut-off, whichever comes earlier

Secondary Outcome Measures:
  • Evaluation of Progression Free Survival by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From randomization until 37 months ] [ Designated as safety issue: No ]
    PFS, defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurs first. PFS censoring rules will be defined in the SAP and follow FDA guidance.

Enrollment: 540
Study Start Date: September 2011
Study Completion Date: May 2016
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01454934

  Show 84 Study Locations
Sponsors and Collaborators
Eisai Inc.
  More Information

Responsible Party: Eisai Inc. Identifier: NCT01454934     History of Changes
Other Study ID Numbers: E7389-G000-302 
Study First Received: October 13, 2011
Last Updated: June 22, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Phytogenic processed this record on October 28, 2016