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Report for Clinical Trial NCT03861156

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Study to Assess the Safety and Efficacy of D-0316 in Patients With Locally Advanced/Metastatic Non Small Cell Lung Cancer Whose Tumors Are Epidermal Growth Factor Receptor Mutation Positive

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of D-0316 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

NCT03861156 Solid Tumor NSCLC EGFR T790M
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: D-0316

Description: Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.
Type: Drug
Group Labels: 1

D-0316


Primary Outcomes

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 months

Secondary Outcomes

Description: 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 months

Description: OS, defined as time from first dose of X-396 to death due to any cause.

Measure: Overall survival (OS)

Time: 36 months

Description: DoR, defined as time from first reponse to disease progression or death

Measure: Duration of response(DoR)

Time: 24 months

Description: 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 months

Description: 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 months

Description: 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 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T790M

D-0316 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 D-0316 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 D-0316 (Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. --- T790M ---

Otherwise, the dose will be maintained at 75mg.) 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 ---



HPO Nodes


HPO: