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

NCT01454934 | Completed Phase 3 Results

• 1 other identifier: E7389-G000-302
• Study Type: interventional
• Target: 540
• Locations: 14 countries
• Sites: 83

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.

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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 Outcomes (2)

• 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

Study Arms (2)

Arm A

EXPERIMENTAL

Drug: Eribulin

Arm B

ACTIVE COMPARATOR

Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed

Interventions

Eribulin DRUG

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.

Arm A

TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed DRUG

* 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).

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all of the following criteria to be included in this study:
• Histologically or cytologically confirmed diagnosis of NSCLC.
• Documented evidence of advanced NSCLC not amenable to surgery or radiotherapy.
• Confirmation of the presence or absence of EGFR mutations prior to study enrolment in all subjects.
• 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.
• Radiographic evidence of disease progression on, or after, the last anti-cancer regimen prior to study entry.
• Presence of measurable disease.
• ECOG performance status of 0, 1, or 2.
• Adequate bone marrow
• Adequate renal function.
• Adequate liver function.
• Female subjects of child-bearing potential must agree to use two forms of highly effective contraception.
• Male subjects and their female partners who are of child-bearing potential must agree to use two forms of highly effective contraception.
• Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
• 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.

You may not qualify if:

• Subjects who meet any of the following criteria will be excluded from this study:
• Subjects who have received any anti-cancer therapy within 14 days, or five half-lives of the drug (whichever is longer), prior to randomization.
• Subjects who have not recovered from toxicities as a result of prior anti-cancer therapy to less than Grade 2.
• 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.
• Peripheral neuropathy more than CTCAE Grade 2.
• Significant cardiovascular impairment.
• Subjects with a high probability of Long QT Syndrome, or QTc interval \>500 ms.
• 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.
• Any serious concomitant illness.
• Known HIV positive, or have an infection requiring treatment.
• 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.
• Female subjects must not be pregnant, and must not be breastfeeding.
• Hypersensitivity to either HalB or HalB chemical derivatives or both, or to any of the excipients of the eribulin formulation.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (83)

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Los Angeles, California, United States

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Pleasant Hill, California, United States

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San Diego, California, United States

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Aurora, Colorado, United States

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Washington D.C., District of Columbia, United States

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Port Saint Lucie, Florida, United States

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Decatur, Illinois, United States

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Southfield, Michigan, United States

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Lebanon, New Hampshire, United States

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Lake Success, New York, United States

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Portland, Oregon, United States

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Spokane, Washington, United States

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Madison, Wisconsin, United States

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Herston, Queensland, Australia

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Frankston, Victoria, Australia

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Strasbourg, Bas Rhin, France

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Marseille, Bouches-du-Rhone, France

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Marseille, Bouches-duRhone, France

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Bordeaux, Gironde, France

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Toulouse, Haute Garonne, France

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Limoges, Haute Vienne, France

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Rennes, Ille Et Vilaine, France

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Saint-Herblain, Loire Atlantique, France

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Lille, Nord, France

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Paris, Paris, France

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Pierre-Bénite, Rhone, France

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Villejuif, Val De Marne, France

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Aschaffenburg, Bavaria, Germany

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Gauting, Bavaria, Germany

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Munich, Bavaria, Germany

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Cologne, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Recklinghausen, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Halle, Saxony-Anhalt, Germany

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Hong Kong, Hong Kong

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Lido di Camaiore, Lucca, Italy

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Monza, Milano, Italy

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Aviano, Pordenone, Italy

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Cremona, Italy

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Milan, Italy

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Siena, Italy

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Nagoya, Aichi-ken, Japan

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Kashiwa-shi, Chiba, Japan

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Fukuoka, Fukuoka, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Kobe, Hygo-Ken, Japan

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Akashi-shi, Hyōgo, Japan

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Sendai, Miyagi, Japan

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Nigata-shi, Nigata-Ken, Japan

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Kurashiki-shi, Okayama-ken, Japan

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Habinko-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Osakasayama-shi, Osaka, Japan

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Sunto-gun, Shizuoka, Japan

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Chūōku, Tokyo-to, Japan

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Kōtoku, Tokyo-To, Japan

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Ube-shi, Yamaguchi, Japan

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Kitaadachi-gun, Japan

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Gdansk, Poland

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Mrozy, Poland

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Otwock, Poland

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Sczedin, Poland

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Warsazawa, Poland

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Barnaul, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Singapore, Singapore

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Seongnam-si, Gyeonggi-do, South Korea

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Suwon, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Sabadell, Barcelona, Spain

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Terrassa, Barcelona, Spain

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Pamplona, Navarre, Spain

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Barcelona, Spain

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Madrid, Spain

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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London, Greater London, United Kingdom

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Manchester, Greater Manchester, United Kingdom

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Sutton, Surrey, United Kingdom

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Related Publications (1)

• Katakami N, Felip E, Spigel DR, Kim JH, Olivo M, Guo M, Nokihara H, Yang JC, Iannotti N, Satouchi M, Barlesi F. A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of eribulin to treatment of physician's choice in patients with advanced non-small cell lung cancer. Ann Oncol. 2017 Sep 1;28(9):2241-2247. doi: 10.1093/annonc/mdx284.

  PMID: 28911085 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

eribulin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_oncmedinfo@eisai.com

1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 19, 2011
• Study Start: December 9, 2011
• Primary Completion: May 30, 2014
• Study Completion: May 2, 2016
• Last Updated: June 22, 2023
• Results First Posted: March 1, 2017

Record last verified: 2017-08

Locations

SG (1); KR (3); ES (5); IT (6); DE (8); RU (3); TW (3); FR (12); JP (18); GB (3); AU (2); US (13); PL (5); HK (1)