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

NCT03866499 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 369

Last updated 2024-08-07

No results posted yet for this study

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

Interventions

DRUG

BPI-7711

180 mg, oral, QD

DRUG

Gefitinib

250 mg, oral, QD

DRUG

Placebo Tablet

250 mg gefitinib placebo tablet, QD

DRUG

Placebo capsule

180 mg BPI-7711 placebo capsule, QD

Sponsors & Collaborators

  • Beta Pharma Shanghai

    lead INDUSTRY

Principal Investigators

  • Yuankai Shi · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2023-11-30
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866499 on ClinicalTrials.gov