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Non-small Cell Lung CancerPhase 2NCT01104155

Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing eribulin mesylate + erlotinib in people with Non-small Cell Lung Cancer, run by Eisai Inc. at 64 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
eribulin mesylate + erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
64 sitesin 7 countries
Study dates
22 Feb 2010to 18 Jan 2017
Phase
Phase 2
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

  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • At least one prior platinum-based doublet anti-cancer treatment for recurrent or advanced NSCLC
  • Disease progression during or after the last anti-cancer therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
  • Serum creatinine less than or equal to 2.0 mg/dL or creatinine clearance 40 mL/min according to Cockcroft and Gault formula:
  • Absolute neutrophil count greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10 g/dL (can be corrected by growth factor or transfusion), and platelet count greater than or equal to 100 x 10^9/L
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  • Total bilirubin less than or equal to 1.5 times the upper limit of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 times ULN (in the case of liver metastases less than or equal to 5 times ULN). In case AP is greater than 3 times ULN (in absence of liver metastases) or greater than 5 times ULN (in presence of liver metastases) AND subject also is known to have bone metastases, the liver specific AP must be separated from the total and used to assess the liver function instead of the total AP.
  • At least one lesion of greater than or equal to 1.5 cm in longest diameter for non-lymph nodes or greater than or equal to 1.5 cm in shortest diameter for lymph nodes which is serially measurable according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.17
  • Males and females, age greater than or equal to 18 years
  • Provide written informed consent
  • Are willing and able to comply with all aspects of the protocol
  • Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (Beta-hCG) at Visit 1 (Screening) and a negative urine pregnancy test prior to starting study drug (Visit 2). Female subjects of childbearing potential must agree to be abstinent or to use highly effective methods of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomised partner) having starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use a highly effective method of contraception (eg, condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drugs and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Those with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).

Who cannot join

  • Prior therapy with eribulin or an tyrosine kinase inhibitor of the epidermal growth factor receptor
  • Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued steroids for this indication for greater than or equal to 4 weeks before starting study treatment. Symptoms attributed to brain metastases must be stable for greater than or equal to 4 weeks before starting study treatment; radiographic stability should be determined by comparing contrast-enhanced computed tomography (CT) or magnetic resonance imaging (MRI) brain scan performed during screening to a prior scan performed 4 weeks earlier.
  • Existing anti-cancer therapy-related toxicities of grade greater than or equal to 2, other than any grade of alopecia or grade less than or equal to 2 neuropathy, which are acceptable
  • Current smokers who will not stop smoking one week prior to treatment and during the study
  • History of congestive heart failure with New York Heart Association (NYHA) Grade greater than II, unstable angina, myocardial infarction within the past 6 months, serious cardiac arrhythmia
  • Electrocardiogram with QTc interval greater than or equal to 500 msec based upon Bazett's formula (QTcB)
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  • Females who are pregnant (positive Beta-hCG test) or breastfeeding
  • Subject with hypersensitivity to eribulin and /or erlotinib or any of the excipients
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
  • Subjects who are known to be human immunodeficiency virus (HIV) positive, because the neutropenia caused by the study treatments may make such subjects particularly susceptible to infection
  • Subjects with active viral hepatitis (A, B, or C) as demonstrated by positive serology
  • Radiotherapy, chemotherapy, biological therapy or investigational agents within 2 weeks prior to start of study treatment
  • Meningeal carcinomatosis
  • History of drug or alcohol dependency or abuse within approximately the last 2 years
  • Medically unfit to receive the study drug or unsuitable for any other reason according to investigator judgment
  • Any history of or concomitant medical condition that, in the opinion of the Investigator, would compromise the subject's ability to safely complete the study
  • Major surgery within 4 weeks before starting study treatment or scheduled for surgery during the projected course of the study

Trial locations and contacts

64 sites in 7 countries.

64 sites in 7 countries

United States50 sites

  • Study site

    Arlington, Virginia

  • Study site

    Aurora, Colorado

  • Study site

    Bessemer, Alabama

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boulder, Colorado

  • Study site

    Chesapeake, Virginia

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, Missouri

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    East Providence, Rhode Island

  • Study site

    Elizabeth City, North Carolina

  • Study site

    Fairfax, Virginia

  • Study site

    Fort Worth, Texas

  • Study site

    Gainesville, Virginia

  • Study site

    Garland, Texas

  • Study site

    Hampton, Virginia

  • Study site

    Jefferson City, Missouri

  • Study site

    Kansas City, Kansas

  • Study site

    Kansas City, Missouri

  • Study site

    La Jolla, California

  • Study site

    Lakewood, Colorado

  • Study site

    Las Vegas, Nevada

  • Study site

    Lee's Summit, Missouri

  • Study site

    Leesburg, Virginia

  • Study site

    Littleton, Colorado

  • Study site

    Lone Tree, Colorado

  • Study site

    Longmont, Colorado

  • Study site

    Newport News, Virginia

  • Study site

    Norfolk, Virginia

  • Study site

    Ocala, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Parker, Colorado

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Port Saint Lucie, Florida

  • Study site

    Portland, Oregon

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Spokane, Washington

  • Study site

    St Louis, Missouri

  • Study site

    Thornton, Colorado

  • Study site

    Tualatin, Oregon

  • Study site

    Vancouver, Washington

  • Study site

    Virginia Beach, Virginia

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Williamsburg, Virginia

  • Study site

    Winchester, Virginia

  • Study site

    Woodbridge, Virginia

Other trials in United States

Thailand4 sites

  • Study site

    Bangkok

  • Study site

    Chiang Mai

  • Study site

    Lampang

  • Study site

    Songkhla

Other trials in Thailand

South Korea3 sites

  • Study site

    Goyang

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

Taiwan3 sites

  • Study site

    Taichung

  • Study site

    Tainan

  • Study site

    Taipei

Other trials in Taiwan

Malaysia2 sites

  • Study site

    George Town

  • Study site

    Kuantan, Pahang

Other trials in Malaysia

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

Official title: The Purpose of This Study is to Investigate Two Different Dose Regimens of Eribulin Mesylate in Combination With Intermittent Erlotinib in Patients With Previously Treated, Advanced Non-small Cell Lung Cancer

This is a Phase 2, multicenter, randomized study of two different dose regimens of eribulin mesylate in combination with intermittent erlotinib in patients with previously treated, advanced non-small cell lung cancer.

Being tested
eribulin mesylate + erlotinib
Keywords
NSCLC, Eribulin Mesylate, Erlotinib
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.

  • eribulin mesylate + erlotinibDrug

    21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.

  • eribulin mesylate + erlotinibDrug

    28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.

Study groups in NCT01104155
Study groupRoleWhat they receive
eribulin mesylate, 21 day cycleActive comparatorNot described
Receives: Drug: eribulin mesylate + erlotinib
eribulin mesylate, 28 day cycleActive comparatorNot described
Receives: Drug: eribulin mesylate + erlotinib

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants whose best overall response (BOR) was either a confirmed complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for target lesions assessed by computed tomography (CT) or magnetic resonance imaging (MRI) and based on investigator assessment. CRs and PRs had to be confirmed by a repeat assessment of response (CR or PR) separated by at least 4 weeks (28 days). CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to have a reduction in short axis to less than 10 millimeters. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR and the corresponding 95% two-sided confidence intervals (CI) were estimated for each treatment regimen using the Clopper-Pearson method for calculating the exact binomial CI. (CR + PR)

    Measured: From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)

Secondary outcomes (4)

  1. Duration of Response (DOR)

    DOR was assessed for participants with a BOR of CR or PR, and was defined as the time from first documented evidence of CR or PR (whichever status was recorded first) until the first documented sign of disease progression or death (due to any cause), whichever was first. DOR was defined for participants with a confirmed CR or PR. For participants in the subset of responders who did not progress or die, duration of response was censored. DOR was analyzed using the Kaplan-Meier method.

    Measured: From date of first document CR or PR (whichever was recorded first) until first documentation of disease progression or death due to any cause, or up to data cutoff (31 May 2013) up to 3.25 years

  2. Progression-Free Survival (PFS)

    PFS was measured as the time from the date of first administration of study treatment until the first documentation of disease progression or death (due to any cause), whichever occurred first, as determined by investigator assessment based on RECIST v1.1. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. For participants who did not have an event (i.e. those who had not progressed, and were alive at the date of data cut-off or lost to Follow-up), progression-free survival was censored. Participants who did not progress in their disease were censored on the date of their last tumor assessment preceding the start of any additional anticancer therapy. PFS was analyzed using the Kaplan-Meier method.

    Measured: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first), or up to data cutoff (31 May 2013) up to 3.25 years

  3. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants who had a BOR of CR or PR, or stable disease (SD; duration of SD lasted for at least 7 weeks). To be assigned a BOR of SD, the time from the first administration of study drug until the date of documented SD was to be greater than or equal to 7 weeks (49 days). A participant's tumor assessment had to be at least 7 weeks following the randomization date to be consider SD. DCR and the corresponding exact Clopper-Pearson 95% CI were computed by treatment regimen. (CR + PR + SD)

    Measured: From date of first dose of study drug until documentation of disease progression or death from any cause (whichever occurred first) or up to data cutoff (31 May 2013), up to approximately 3.25 years

  4. Overall Survival (OS)

    OS was defined as the length of time in months from the date of first administration of study drug until the date of death from any cause, and was based on the data cutoff date. In the absence of confirmation of death, participants were censored either at the date that the participant was last known to be alive or the date of study cutoff, whichever came first. OS and the corresponding 2-sided 95% CI was analyzed using the Kaplan-Meier method.

    Measured: From date of first dose of study drug until date of death from any cause or up to data cutoff (31 May 2013), up to approximately 3.25 years

Timeline

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

  1. First posted15 Apr 2010 (estimated)
  2. Study start22 Feb 2010
  3. Primary completion7 Apr 2011
  4. Study completion18 Jan 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01104155
Sponsor's protocol ID
E7389-G000-205
Status last verified
Jan 2018
First submitted
12 Apr 2010
Last updated
22 Jun 2023

Publications

  • Mok TS, Geater SL, Iannotti N, Thongprasert S, Spira A, Smith D, Lee V, Lim WT, Reyderman L, Wang B, Gopalakrishna P, Garzon F, Xu L, Reynolds C. Randomized phase II study of two intercalated combinations of eribulin mesylate and erlotinib in patients with previously treated advanced non-small-cell lung cancer. Ann Oncol. 2014 Aug;25(8):1578-84. doi: 10.1093/annonc/mdu174. Epub 2014 May 14.

    PubMed 24827127

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing eribulin mesylate + erlotinib in people with Non-small Cell Lung Cancer, run by Eisai Inc. at 64 sites in 7 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 13 inclusion and 17 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 64 sites in United States, Thailand, South Korea, Taiwan, Malaysia and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Feb 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?

Objective Response Rate (ORR) (time frame: From date of first dose of study drug until, or up to the date of data cutoff (07 Apr 2011)). 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 NCT01104155, 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.

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