D4190C00006 - Ph 1b MEDI4736 in Advanced Non-Small Cell Lung Cancer
Research type
Research Study
Full title
A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination with Tremelimumab in Subjects with Advanced Non-small Cell Lung Cancer
IRAS ID
199892
Contact name
Hendrik-Tobias Arkenau
Contact email
Sponsor organisation
MedImmune LLC
Eudract number
2015-003715-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 26 days
Research summary
Cancer continues to be a major global health burden. There continues to be an unmet need for more effective and less toxic therapies, especially for patients with advanced refractory disease. Recent advances in immunotherapy offer promise for improving outcomes in patients with advanced non-small cell lung cancer (NSCLC).
Research has shown that in some patients, cancer and immune cells start to express signals that stop the body’s immune system from killing the cancer. MEDI4736 and tremelimumab are new experimental drugs (laboratory-created antibodies) being developed to help one’s immune system to prevent or slow down growth of cancer cells.
Part 1 of this phase 1b, open-label study, in patients with NSCLC to determine the dose of MEDI4736 and tremelimumab when given in combination that is safe and tolerable is completed. Part 2 (dose-expansion) will assess the safety and tolerability of MEDI4736 and tremelimumab when given in combination followed by MEDI4736 monotherapy as well as MEDI4736 given as monotherapy in cases where a participant experiences an immune-related adverse event.
The study will involve a screening period (approx 4-6 weeks), treatment period (up to 1 year) and a follow-up period (approx 5 years).
A number of different tests will need to be done to determine if these drugs work, learn what side effects there might be, how much of each drug is in the blood at various times, the immune system status following treatment, whether the body produces antibodies against these drugs, and what effect these drugs have on cancer. These include tumour biopsies, physical examinations, ECGs, blood and urine analyses, as well as CT and MRI scans.
Approximately 300 participants at 100 clinical research sites globally will be enrolled in the dose-expansion phase which has 3 treatment groups. Entry into each of the 3 treatment groups depends on prior treatment for lung cancer.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
16/NE/0066
Date of REC Opinion
31 Mar 2016
REC opinion
Further Information Favourable Opinion