A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive
Name: D0316
Description: D0316 was orally given once a day in a 21-day cycleType: DrugD0316
Description: ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).
Measure: Objective response rate based on independent radiology review Time: 24 monthsDescription: PFS, defined as time from first dose of X-396 to progression or death due to any cause.
Measure: Progression-free survival (PFS) as assessed by independent radiology review and investigator Time: 36 monthsDescription: OS, defined as time from first dose of X-396 to death due to any cause.
Measure: Overall survival (OS) Time: 36 monthsDescription: DoR, defined as time from first reponse to disease progression or death
Measure: Duration of response(DoR) Time: 24 monthsDescription: DCR, defined as proportion of complete response, partial response, and disease stabilization to the proportion of patients with evaluable tumors.
Measure: Disease control rate(DCR) Time: 24 monthsDescription: iPFS, defined as the time between baseline brain metastases, from the date of study drug administration to the time between the onset of intracranial tumor progression or death.
Measure: Intracranial Progression-free survival(iPFS) Time: 36 monthsDescription: iORR, defined as the proportion of subjects with complete intracranial response, partial intracranial response to subjects with brain metastases at baseline.
Measure: Intracranial objective response rate(iORR) Time: 24 monthsSingle Group Assignment
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D0316 in Patients With EGFR Positive Non Small Cell Lung Cancer A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D0316 in Patients with Locally Advanced/Metastatic Non Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours are Epidermal Growth Factor Receptor Mutation and T790M Mutation Positive Objective response rate based on independent radiology review. --- T790M ---
- patients must also have confirmation of tumour T790M mutation status (confirmed positive) after disease progression on the prior EGFR TKI. - Eastern cooperative oncology group performance status (ECOG PS) of 0-1. - a minimum life expectancy of 12 weeks. --- T790M ---
Solid Tumor NSCLC EGFR T790M Carcinoma, Non-Small-Cell Lung This is a phase II, open label, single arm study assessing the safety and efficacy of D0316 (50 mg, orally, once daily) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent. --- T790M ---
Solid Tumor NSCLC EGFR T790M Carcinoma, Non-Small-Cell Lung This is a phase II, open label, single arm study assessing the safety and efficacy of D0316 (50 mg, orally, once daily) in patients with a confirmed diagnosis of Epidermal Growth Factor Receptor mutation positive and T790M mutation positive NSCLC,who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) agent. --- T790M --- --- T790M ---