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

NCT03866499 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: BPI-7711301
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

NSCLC

Keywords

EGFR mutation; EGFR TKI; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival evaluated by Blinded Independent Center Review

  up to approximately 16 months

Secondary Outcomes (6)

• Progression-free survival

  up to approximately 16 months

• Objective response rate

  up to approximately 16 months

• Best objective response

  up to approximately 16 months

• Disease control rate

  up to approximately 16 months

• Duration of response

  up to approximately 16 months

Study Arms (2)

BPI-7711

EXPERIMENTAL

180 mg BPI-7711 capsule + 250mg gefitinib placebo tablet, QD

Drug: BPI-7711; Drug: Placebo Tablet

Gefitinib

ACTIVE COMPARATOR

180 mg BPI-7711 placebo capsule + 250mg gefitinib tablet, QD

Drug: Gefitinib; Drug: Placebo capsule

Interventions

BPI-7711 DRUG

180 mg, oral, QD

Also known as: BPI-7711 capsule

BPI-7711

Gefitinib DRUG

250 mg, oral, QD

Also known as: Iressa

Gefitinib

Placebo Tablet DRUG

250 mg gefitinib placebo tablet, QD

Also known as: placebo

BPI-7711

Placebo capsule DRUG

180 mg BPI-7711 placebo capsule, QD

Also known as: placebo

Gefitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beta Pharma Shanghai: lead

Study Sites (3)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Linyi Cancer Hospital

Linyi, Shandong, China

Location

Related Publications (1)

• Shi Y, Guo Y, Li X, Wu L, Chen Z, Yang S, Bi M, Zhao Y, Yao W, Yu H, Wang K, Zhao W, Sun M, Zhang L, He Z, Lin Y, Shi J, Zhu B, Wang L, Pan Y, Shi H, Sun S, Wen M, Zhou R, Guo S, Han Z, Yi T, Zhang H, Cang S, Yu Z, Zhong D, Cui J, Fang J, Gao J, Li M, Ma R, Jiang M, Qin J, Shu Y, Ye F, Hu S, Li W, Lu H, Yang M, Yi S, Zhang Y, Fan Y, Ji H, Liu Z, Wang H, Zhou X, Zhang D, Peng J, Shen H, Gao F, Wang T, Zhou A. Rezivertinib versus gefitinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (REZOR): a multicentre, double-blind, randomised, phase 3 study. Lancet Respir Med. 2025 Apr;13(4):327-337. doi: 10.1016/S2213-2600(24)00417-X. Epub 2025 Feb 3.

  PMID: 39914443 DERIVED

MeSH Terms

Interventions

rezivertinib; Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yuankai Shi

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: April 30, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)