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 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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000100897

Enrollment

540

Registered

2012-01-20

Start date

2011-09-12

Completion date

2012-11-07

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomized, open-label, multicenter, Phase 3 study, comparing the efficacy and safety of eribulin with TPC in subjects with advanced NSCLC and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

Interventions

Administration of eribulin mesylate at a dose of 1.4 mg/m2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days. Treatment will continue until disease progression, development of unacceptable toxicity or withdrawal of consent.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically or Cytologically confirmed diagnosis of NSCLC 2. Advanced NSCLC not amenable to surgery or radiotherapy, with radiological evidence of disease progression following the last anti-cancer treatment. 3. Presence of Measurable Tumour Disease 4. Confirmation of the presence or absence of EGFR mutations prior to study enrolment. However, subjects with unknown EGFR status and who have received prior treatment with an EGFR Tyrosine Kinase Inhibitor (TKI) can be enrolled. 5. Subjects must have received at least two prior regimens of treatment for advanced NSCLC, which should have included a platinum based treatment and in subjects with tumours harbouring EGFR mutations, an EGFR TKI. 6. ECOG performance status 0,1 or 2 7. Adequate Liver, Renal and Bone marrow functions.

Exclusion criteria

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. Pre-existing peripheral neuropathy more than CTCAE Grade 2 5. Significant cardiovascular impairment 6. Subjects with a high probability of Long QT Syndrome 7. Subjects with active brain or subdural metastases

Outcome results