LY2606368 in Extensive Stage Disease Small Cell Lung Cancer
Research type
Research Study
Full title
A Phase 2 Study of LY2606368 in Patients with Extensive Stage Disease Small Cell Lung Cancer
IRAS ID
198164
Contact name
Martin Forster
Contact email
Sponsor organisation
Eli Lilly & Company Limited
Eudract number
2015-005069-21
Duration of Study in the UK
2 years, 2 months, 10 days
Research summary
Study I4DMCJTJH is a non-randomised, open-label, parallel-cohort, Phase 2 study to evaluate the effectiveness of LY2606368 in patients with extensive stage disease small cell lung cancer (ED-SCLC).
Lung cancer is the leading cause of death due to cancer. Small-cell lung cancer (SCLC) refers to a rapidly growing tumor which forms in the tissues of the lung and about two-thirds of patients with SCLC have ED-SCLC.The study will be split into two cohorts; cohort 1 will consist of patients who have platinum-sensitive disease and cohort 2 will include patients with platinum resistant/refractory disease.
To be eligible to participate in this study patients must be over 18 years old and have a diagnosis of ED-SCLC and have received a prior platinum-based treatment.
Patients will receive an infusion of the study medication at a dose of 105 mg/m2 over approximately 60 minutes on day 1 every 14 days. An infusion is when medication is injected into a vein via a drip. Study medication will be injected into a vein via a drip over 60 minutes every 2 weeks. The study will last up to 1 year after the last patient enrols but patients who are still on LY2606368 at the time of study completion may continue to receive treatment if they are experiencing clinical benefit and no undue risks.
Study assessments will include: Physical examinations, Questionnaire completion, Blood and urine tests and radiological scans (CT, MRI or PET scans might be used).
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/0448
Date of REC Opinion
20 Apr 2016
REC opinion
Further Information Favourable Opinion