A Study of INC280 (Alone or in Combination) in Patients with NSCLC
Research type
Research Study
Full title
A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/pemetrexed in adult patients with EGFR mutated, cMET-amplified, locally advanced/metastatic non small cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI)
IRAS ID
197817
Contact name
Lisa Tran
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-001241-84
Duration of Study in the UK
2 years, 1 months, 8 days
Research summary
Lung Cancer leads to the death of nearly 1.6 million people each year worldwide. It can be divided into two main types: small cell and non-small cell lung cancer. In around 4% of patients with non-small cell lung cancer, genetic mutations or alterations cause the cMET molecular signalling pathway to become overactive, triggering tumour growth. The trial is targeting cMET with INC280.
INC280, is an orally bioavailable highly potent and selective cMET inhibitor capable of blocking cMET activation.
The purpose of this study is to see whether INC280, alone or in combination with erlotinib is a safe and effective treatment for people with non-small cell lung cancer (NSCLC) compared to chemotherapy.
The study is divided into two phases:
Phase 1: To find the best dose of INC280 that will be given together with erlotinib
Phase II: Using the best dose of INC280 discovered in Phase I, patients will be allocated randomly (an equal chance) into one of 3 groups:
1.INC280
2.INC280 plus erlotinib
3.Chemotherapy (pemetrexed with either cisplatin or carboplatin)Around 135 patients will be invited to take part in this study from many different countries. The UK will take part in the Phase II only. Only patients who have tested cMET positive and passed the screening assessments will be eligible for treatment. During the treatment period, patients will be asked to take study medication as instructed and attend hospital every 21 days for study assessments. Patients on one of the INC280 arms will continue to receive study treatment as long as the cancer is not growing and they are tolerating the drug without unacceptable side-effects. Patients on the chemotherapy arm will take 6 cycles of treatment.
This trial is sponsored by the pharmaceutical company named Novartis.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0020
Date of REC Opinion
24 Mar 2016
REC opinion
Further Information Favourable Opinion