D-0316 First Time in Patients Ascending Dose Study

A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase

This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
• Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
• Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib. In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
• Confirmation that the tumour harbours an EGFR T790M mutation.
• No deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
• Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria:

• Treatment with an EGFR TKI (erlotinib or gefitinib) within 14 days of the first dose of study treatment.
• Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.

Other protocol defined inclusion/exclusion criteria could apply