SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03866499

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Randomized, Double-blind, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of BPI-7711 Capsule in Locally Advanced or Recurrent/Metastatic Treatment-naïve Non-small Cell Lung Cancer Patients With EGFR Mutation

A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR mutation

NCT03866499 NSCLC
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

4 Interventions

Name: BPI-7711

Description: 180 mg, oral, QD

Type: Drug

BPI-7711

Name: Gefitinib

Description: 250 mg, oral, QD

Type: Drug

Gefitinib

Name: Placebo Tablet

Description: 250 mg gefitinib placebo tablet, QD

Type: Drug

BPI-7711

Name: Placebo capsule

Description: 180 mg BPI-7711 placebo capsule, QD

Type: Drug

Gefitinib


Primary Outcomes

Description: Progression-free survival evaluated by Blinded Independent Center Review

Measure: Progression-free survival

Time: up to approximately 16 months

Secondary Outcomes

Description: Progression-free survival evaluated by investigators

Measure: Progression-free survival

Time: up to approximately 16 months

Description: Objective response rate

Measure: Objective response rate

Time: up to approximately 16 months

Description: Best objective response

Measure: Best objective response

Time: up to approximately 16 months

Description: Disease control rate

Measure: Disease control rate

Time: up to approximately 16 months

Description: Duration of response

Measure: Duration of response

Time: up to approximately 16 months

Description: Overall survival

Measure: Overall survival

Time: up to approximately 30 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 T790M

- Primary T790M mutation-positive patient. --- T790M ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1