Status:
ACTIVE_NOT_RECRUITING
A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
Lead Sponsor:
Beta Pharma Shanghai
Conditions:
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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 recur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT03866499
Start Date
April 30 2021
End Date
December 30 2025
Last Update
August 7 2024
Active Locations (3)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
2
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
3
Linyi Cancer Hospital
Linyi, Shandong, China