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

Beta Pharma

Status and phase: Active, not recruiting; Phase 3

Conditions: NSCLC

Treatments: Drug: Placebo Tablet; Drug: Placebo capsule; Drug: Gefitinib; Drug: BPI-7711

Study type: Interventional

Funder types: Industry

Identifiers

NCT03866499

BPI-7711301

Details and patient eligibility

About

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

Full 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.

Enrollment: 369 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

369 participants in 2 patient groups

BPI-7711

Experimental group

Description:

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

Treatment:

Drug: BPI-7711

Drug: Placebo Tablet

Gefitinib

Active Comparator group

Description:

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

Treatment:

Drug: Gefitinib

Drug: Placebo capsule