A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03866499
• Other study ID #: BPI-7711301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 30, 2021
• Est. completion date: February 29, 2024

Study information

• Verified date: September 2023
• Source: Beta Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a Phase III clinical study, which aims to compare the efficacy and safety of BPI-7711 capsule and gefitinib tablet in the treatment of initially-treated patients with locally advanced or recurrent metastatic with EGFR mutation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 369
• Est. completion date: February 29, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer.

• The ECOG score of performance status is 0-1.

• Locally advanced or recurrent metastatic NSCLC that has never received systemic treatment.

• According to RECIST1.1 criteria, there is at least 1 measurable lesion that has not been previously irradiated.

• Prior to enrollment, a central laboratory testing report has confirmed that the tumor has one of two common EGFR mutations positive that are sensitive to EGFR-TKI therapy, accompanied with or not accompanied with other EGFR mutation, with the exception of exon 20 insertion.

Exclusion Criteria:

• Previously received systemic treatment for locally advanced or recurrent metastatic cancer.

• Primary T790M mutation-positive patient.

• Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormonal therapy, or any clinically proven active interstitial lung disease.

• Known active infections such as hepatitis B, hepatitis C, and human immunodeficiency virus.

• Local radiation therapy is carried out within 1 week; more than 30% bone marrow radiation therapy or extensive radiation therapy is performed within 4 weeks.

• = 4 weeks from major surgery or = 2 weeks from minor surgery.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• BPI-7711
180 mg, oral, QD
• Gefitinib
250 mg, oral, QD
• Placebo Tablet
250 mg gefitinib placebo tablet, QD
• Placebo capsule
180 mg BPI-7711 placebo capsule, QD

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Linyi Cancer Hospital	Linyi	Shandong
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beta Pharma Shanghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression-free survival evaluated by Blinded Independent Center Review	up to approximately 16 months
Secondary	Progression-free survival	Progression-free survival evaluated by investigators	up to approximately 16 months
Secondary	Objective response rate	Objective response rate	up to approximately 16 months
Secondary	Best objective response	Best objective response	up to approximately 16 months
Secondary	Disease control rate	Disease control rate	up to approximately 16 months
Secondary	Duration of response	Duration of response	up to approximately 16 months
Secondary	Overall survival	Overall survival	up to approximately 30 months