INC280 + PDR001 versus docetaxel in pre-treated, advanced ALK-ve NSCLC
Research type
Research Study
Full title
A phase II, multicenter, randomized, two-arm study of capmatinib (INC280, an oral MET inhibitor) and spartalizumab (PDR001, a PD-1 inhibitor) combination therapy versus docetaxel in pretreated adult patients with EGFR wild-type, ALK rearrangement negative locally advanced/metastatic non-small cell lung cancer.
IRAS ID
255809
Contact name
Carles Escriu
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-001420-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 21 days
Research summary
The purpose of this research study is to learn whether the combination of the drugs capmatinib plus spartalizumab helps to control lung cancer better compared to a single agent chemotherapy (docetaxel) and whether it is safe when given to patients with non-small cell lung cancer (NSCLC). Capmatinib targets particular processes, which may not be working properly in the cancer cells in the body (called dysregulation) and which may be causing the cancer. This is taken in a tablet swallowed 2 times a day.
Spartalizumab is an antibody (a kind of protein that binds to a specific "target" protein). By blocking its "target" protein, called PD-1, spartalizumab may increase the activity of a certain type of cells in the immune system, which may reduce the growth of the tumour. This is given intravenously (IV) every 4 weeks in clinic.
Docetaxel is a standard chemotherapy medicine commonly used to treat NSCLC. This is given intravenously (IV) every 3 weeks in clinic.
Participants have advanced/metastatic NSCLC after their cancer has progressed following previous treatment called platinum doublet chemotherapy and checkpoint inhibitor.
About 105 participants will join in this study in about 47 hospitals worldwide, including the UK. 75 participants will be treated with the combination of capmatinib plus spartalizumab and 30 with docetaxel.
The length of time participants will be in the study will depend on how they respond to the study treatment, and is expected to be about 1 year. This would include 16 - 20 clinic visits for study tests to monitor health and the disease including blood and urine samples. Some visits include CT or MRI scans and an ECG. A tumour biopsy will be done if there is no previously collected tumour sample available.
The study is being funded by Novartis Pharma Services, Lichstrasse 35, 4056 Basel Switzerland.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/2146
Date of REC Opinion
24 Jan 2019
REC opinion
Further Information Favourable Opinion