INC280 in NSCLC patients with cMET activated pathway
Research type
Research Study
Full title
A phase II, multicenter, four-cohort study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC) who have received one or two prior lines of systemic therapy for advanced/metastatic disease
IRAS ID
197351
Contact name
Joyce Thompson
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2014-003850-15
Duration of Study in the UK
2 years, 9 months, 9 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 signaling 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 aim of the trial is to see if INC280 will be a clinically effective treatment for stopping or slowing the tumour in this group of non small cell lung cancer patients.
Around 276 patients will be invited to take part in the study from many different countries including the UK. 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 INC280 twice daily by mouth and attend hospital every 21 days for study assessments. Patients will continue to receive study treatment as long as the cancer is not growing and they are tolerating the drug without unacceptable side-effects.
This trial is sponsored by the pharmaceutical company named Novartis and because the safety and efficacy profile of INC280 has not yet been established, access to this investigational compound is available only through carefully controlled and monitored clinical trials such as this.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
16/EM/0032
Date of REC Opinion
7 Mar 2016
REC opinion
Further Information Favourable Opinion