Clinical trial NCT03866499: A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: NSCLC
Keywords: EGFR mutation
EGFR TKI
NSCLC
Lead sponsor: Beta Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-07
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival
timeFrame: up to approximately 16 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: up to approximately 16 months
measure: Objective response rate
timeFrame: up to approximately 16 months
measure: Best objective response
timeFrame: up to approximately 16 months
measure: Disease control rate
timeFrame: up to approximately 16 months
measure: Duration of response
timeFrame: up to approximately 16 months
measure: Overall survival
timeFrame: up to approximately 30 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yuankai Shi
role: PRINCIPAL_INVESTIGATOR
References: