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

Eisai

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer (NSCLC)

Treatments: Drug: TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed; Drug: Eribulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01454934

E7389-G000-302

Details and patient eligibility

About

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.

Enrollment: 540 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Eribulin

Arm B

Active Comparator group

Treatment:

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