Non-Small Cell Lung Cancer (NSCLC)Phase 3NCT01454934

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

A Phase 3 study testing Eribulin and TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed in people with Non-Small Cell Lung Cancer (NSCLC), run by Eisai Inc. at 83 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer (NSCLC)
What is being tested?: Eribulin and TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 540 participants
Where: 83 sitesin 14 countries
Study dates: 9 Dec 2011to 2 May 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

83 sites in 14 countries.

Country

City, postcode or hospital

83 sites in 14 countries

Japan18 sites

Study site
Akashi-shi, Hyōgo
Study site
Chūōku, Tokyo-to
Study site
Fukuoka, Fukuoka
Study site
Habinko-shi, Osaka
Study site
Hiroshima, Hiroshima
Study site
Kashiwa-shi, Chiba
Study site
Kitaadachi-gun
Study site
Kobe, Hygo-Ken
Study site
Kōtoku, Tokyo-To
Study site
Kurashiki-shi, Okayama-ken
Study site
Nagoya, Aichi-ken
Study site
Nigata-shi, Nigata-Ken
Study site
Osaka, Osaka
Study site
Osakasayama-shi, Osaka
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Sunto-gun, Shizuoka
Study site
Ube-shi, Yamaguchi

Other trials in Japan

United States13 sites

Study site
Aurora, Colorado
Study site
Decatur, Illinois
Study site
Lake Success, New York
Study site
Lebanon, New Hampshire
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Pleasant Hill, California
Study site
Port Saint Lucie, Florida
Study site
Portland, Oregon
Study site
San Diego, California
Study site
Southfield, Michigan
Study site
Spokane, Washington
Study site
Washington D.C., District of Columbia

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France12 sites

Study site
Bordeaux, Gironde
Study site
Lille, Nord
Study site
Limoges, Haute Vienne
Study site
Marseille, Bouches-du-Rhone
Study site
Marseille, Bouches-duRhone
Study site
Paris, Paris
Study site
Pierre-Bénite, Rhone
Study site
Rennes, Ille Et Vilaine
Study site
Saint-Herblain, Loire Atlantique
Study site
Strasbourg, Bas Rhin
Study site
Toulouse, Haute Garonne
Study site
Villejuif, Val De Marne

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Germany8 sites

Study site
Aschaffenburg, Bavaria
Study site
Cologne, North Rhine-Westphalia
Study site
Essen, North Rhine-Westphalia
Study site
Gauting, Bavaria
Study site
Halle, Saxony-Anhalt
Study site
Mainz, Rhineland-Palatinate
Study site
Munich, Bavaria
Study site
Recklinghausen, North Rhine-Westphalia

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Italy6 sites

Study site
Aviano, Pordenone
Study site
Cremona
Study site
Lido di Camaiore, Lucca
Study site
Milan
Study site
Monza, Milano
Study site
Siena

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Poland5 sites

Study site
Gdansk
Study site
Mrozy
Study site
Otwock
Study site
Sczedin
Study site
Warsazawa

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Spain5 sites

Study site
Barcelona
Study site
Madrid
Study site
Pamplona, Navarre
Study site
Sabadell, Barcelona
Study site
Terrassa, Barcelona

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Russia3 sites

Study site
Barnaul
Study site
Novosibirsk
Study site
Saint Petersburg

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South Korea3 sites

Study site
Seongnam-si, Gyeonggi-do
Study site
Seoul, Korea
Study site
Suwon, Gyeonggi-do

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Taiwan3 sites

Study site
Taichung
Study site
Tainan
Study site
Taipei

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United Kingdom3 sites

Study site
London, Greater London
Study site
Manchester, Greater Manchester
Study site
Sutton, Surrey

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Australia2 sites

Study site
Frankston, Victoria
Study site
Herston, Queensland

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Hong Kong1 site

Study site
Hong Kong

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Singapore1 site

Study site
Singapore

Other trials in Singapore

About this study

Conditions: Non-Small Cell Lung Cancer (NSCLC)
Being tested: Eribulin, TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EribulinDrug
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.
TPC -Vinorelbine,Gemcitabine,Docetaxel, and PemetrexedDrug
- 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).

Study groups in NCT01454934
Study group	Role	What they receive
Arm A	Experimental	Not described Receives: Drug: Eribulin
Arm B	Active comparator	Not described Receives: Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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.
Measured: Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months
Objective Response Rate (ORR)
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.
Measured: Randomization (Day 1) to CR or PR

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20112 May 2016

First posted19 Oct 2011 (estimated)
Study start9 Dec 2011
Primary completion30 May 2014
Study completion2 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
More trials run by Eisai Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 540 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01454934
Sponsor's protocol ID: E7389-G000-302
Status last verified: Aug 2017
First submitted: 13 Oct 2011
Last updated: 22 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28911085

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01454934
Acronym / sponsor ID: E7389-G000-302
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 540 participants (actual)
Lead sponsor: Eisai Inc.Industry (pharma, biotech, devices)
Study start: 9 Dec 2011 (actual)
Primary completion: 30 May 2014 (actual)
Study completion: 2 May 2016 (actual)
First posted: 19 Oct 2011 (estimated)
Results: Posted 1 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: Eribulin
Arm B	Active comparator	Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EribulinAdministration 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.	Drug	Arm A
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).	Drug	Arm B

Primary outcome

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.

2 secondary outcomes

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
Objective Response Rate (ORR)
Time frame: Randomization (Day 1) to CR or PR

Results and safety

Results posted to the registry on 1 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Eribulin Mesylate	270	0
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed	270	0

Primary outcome: Overall Survival (OS)

Time frame: Randomization (Day 1) until date of death from any cause, or 37 months. Median (95% Confidence Interval). Unit: months

Measure	Arm A: Eribulin Mesylate n = 270	Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed n = 270
Value	9.5 (7.4 to 11.4)	9.5 (8.5 to 11.3)

Arm A: Eribulin Mesylate vs Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed: Hazard Ratio (HR): 1.16 (95% CI 0.95 to 1.41), p = 0.1343, Log Rank

Population analysed: Full analysis set included all randomized participants.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (AEs) and serious adverse events (SAEs) were collected from the first dose of study treatment to thirty days after final dose of study medication. Participants were followed for approximately 37 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Eribulin Mesylate	96 of 269 (35.7%)	254 of 269 (94.4%)	28 of 269
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed	86 of 268 (32.1%)	261 of 268 (97.4%)	21 of 268

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28911085Katakami 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

83 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eribulin and TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed in people with Non-Small Cell Lung Cancer (NSCLC), run by Eisai Inc. at 83 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in Japan, United States, France, Germany, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Randomization (Day 1) until date of death from any cause, or 37 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01454934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.