Pembrolizumab + Lenvatinib verses Docetaxel in 2L+ NSCLC (LEAP-008)
Research type
Research Study
Full title
A Phase 3, multicenter, randomized, open-label trial to compare the efficacy and safety of pembrolizumab (MK-3475) in combination with lenvatinib (E7080/MK-7902) versus docetaxel in previously treated participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and immunotherapy (anti-PD-1/PD-L1 inhibitor) (LEAP-008)
IRAS ID
260477
Contact name
Ahmed Samreen
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2018-003791-12
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Non Small Cell Lung Cancer is the most common type of lung cancer, accounting for about 85 percent of all cases. Pembrolizumab is an immunotherapy. It helps cells in the immune system to attack cancer cells. Pembrolizumab with or without chemotherapy is already used to help people with other types of cancer including non small cell lung cancer. Although patients have durable response to immunotherapy, over time, the cancer often progresses again.
Lenvatinib is multi-kinase inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors. Results from earlier studies indicate lenvatinib reduces production of immune suppressing cells and enhances the anti tumour effect pembrolizumab.
The current study is designed to further evaluate the safety and efficacy of combination therapy with pembrolizumab + lenvatinib versus docetaxel in NSCLC patients who have disease progression after platinum doublet chemotherapy and acquired resistance to immunotherapy. This is an international phase 3 study, estimated to run for 5 years. Approximately 346 participants will receive pembrolizumab + lenvatinib or docetaxel (Group 1), and approximately 45 participants will receive lenvatinib alone (Group 2). Pembrolizumab and Docetaxel are administered by infusion in the hospital. Lenvatinib capsules are taken at home.
There are certain criteria that all participants (Group 1 and Group 2) must meet to join the study. Participants will need to visit the hospital more often than normal and will have procedures such as blood tests, physical examinations, CT or MRI scans. Participants in Group 1 will also be asked to provide new sample of tumour tissue from new biopsy.
The study is sponsored by Merck Sharp & Dohme Limited (MSD), and co-funded by MSD and Eisai. It will take place at 10 study centres in UK.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0041
Date of REC Opinion
28 Mar 2019
REC opinion
Further Information Favourable Opinion