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

Inclusion:

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.

Exclusion:

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.