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
Condition: Non-Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Eribulin; TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed
Intervention description: 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.; 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).
Intervention MeSH terms: Gemcitabine; Docetaxel; Pemetrexed; Vinorelbine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 540.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.