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

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

Study Overview

• Status: Active, not recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: BPI-7711; Drug: Placebo Tablet; Drug: Gefitinib; Drug: Placebo capsule

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 369
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Shandong
    • Linyi, Shandong, China
      • Linyi Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BPI-7711; 180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD	Drug: BPI-7711; 180 mg, oral, QD; Other Names: BPI-7711 capsule; Drug: Placebo Tablet; 250 mg gefitinib placebo tablet, QD; Other Names: placebo
Active Comparator: Gefitinib; 180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD	Drug: Gefitinib; 250 mg, oral, QD; Other Names: Iressa; Drug: Placebo capsule; 180 mg BPI-7711 placebo capsule, QD; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival evaluated by Blinded Independent Center Review	up to approximately 16 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival evaluated by investigators	up to approximately 16 months
Objective response rate	Objective response rate	up to approximately 16 months
Best objective response	Best objective response	up to approximately 16 months
Disease control rate	Disease control rate	up to approximately 16 months
Duration of response	Duration of response	up to approximately 16 months
Overall survival	Overall survival	up to approximately 30 months

Collaborators and Investigators

• Sponsor: Beta Pharma Shanghai
• Investigators: Principal Investigator: Yuankai Shi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): February 29, 2024

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: NSCLC; EGFR mutation; EGFR TKI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib
• Other Study ID Numbers: BPI-7711301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No