SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03812809

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase IIb, Open-label, Single-arm Study to Assess the Safety and Efficacy of BPI-7711 Capsule in Patients With Metastatic or Recurrent Non-small Cell Lung Cancer With EGFR Mutation and T790M Mutation Positive.

A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711 capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR mutation and T790M mutation positive.

NCT03812809 NSCLC
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: BPI-7711

Description: BPI-7711: 180mg, QD, oral
Type: Drug
Group Labels: 1

BPI-7711


Primary Outcomes

Description: Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

Measure: ORR according to RECIST 1.1 by an Independent Central Review (ICR)

Time: up to 52 weeks

Secondary Outcomes

Description: Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by MRI or CT. ORR is the percentage of patients with at least 1 visit response of CR or PR (according to independent review) that was confirmed at least 4 weeks later, prior to progression or further anti-cancer therapy.

Measure: ORR according to RECIST 1.1 by investigators

Time: up to 52 weeks

Description: DCR is the percentage of patients with best response of CR, PR or SD (according to independent review), prior to progression (PD) or further anti-cancer therapy.

Measure: Disease control rate (DCR) according to RECIST 1.1

Time: up to 104 weeks

Description: PFS is the time from date of first dose until the date of PD (by independent review) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from BPI-7711 therapy or received another anti-cancer therapy prior to progression. Patients who had not progressed or died at the time of analysis were censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment.

Measure: Progression free survival(PFS) according to RECIST 1.1

Time: up to 104 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 3 SNPs

SNPs


1 L858R

- Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q). --- L858R ---


2 L861Q

- Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be associated with EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q). --- L858R --- --- L861Q ---


3 T790M

A Phase IIb, Open-label, Single-arm Study to Assess the Safety and Efficacy of BPI-7711 Capsule in Patients With Metastatic or Recurrent Non-small Cell Lung Cancer With EGFR Mutation and T790M Mutation Positive.. --- T790M ---

A Phase IIb Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients With T790M Mutation Positive A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711 capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR mutation and T790M mutation positive. --- T790M ---

A Phase IIb Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients With T790M Mutation Positive A phase IIb, open-label, single-arm study to assess the safety and efficacy of BPI-7711 capsule in patients with metastatic or recurrent non-small cell lung cancer with EGFR mutation and T790M mutation positive. --- T790M --- --- T790M ---

- Patients must have central confirmation of tumor T790M mutation+ status from a biopsy sample or a plasma sample taken after confirmation of disease progression on the most recent EGFR-TKI treatment. --- T790M ---

Primary T790M mutation positive patients should provide prior written evidence before ICF signature and have not received any EGFR-TKI. --- T790M ---

- Treatment with any 3rd generation EGFR TKIs target on T790M mutation. --- T790M ---

NSCLC Carcinoma, Non-Small-Cell Lung This is a phase IIb, open-label, single arm study assessing the safety and efficacy of BPI-7711 (180 mg, orally, once daily) in China with a confirmed diagnosis of EGFR sensitizing mutation positive and T790M mutation+ unresectable, locally advanced or metastatic NSCLC, who have progressed on prior EGFR-TKIs treatment. --- T790M ---



HPO Nodes


HPO: