NSCLC
Conditions
Keywords
EGFR mutation, EGFR TKI, NSCLC
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.
Interventions
DRUGBPI-7711
180 mg, oral, QD
DRUGGefitinib
250 mg, oral, QD
DRUGPlacebo Tablet
250 mg gefitinib placebo tablet, QD
DRUGPlacebo capsule
180 mg BPI-7711 placebo capsule, QD
Sponsors
Beta Pharma Shanghai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to approximately 16 months | Progression-free survival evaluated by Blinded Independent Center Review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | up to approximately 16 months | Objective response rate |
| Best objective response | up to approximately 16 months | Best objective response |
| Progression-free survival | up to approximately 16 months | Progression-free survival evaluated by investigators |
| Duration of response | up to approximately 16 months | Duration of response |
| Overall survival | up to approximately 30 months | Overall survival |
| Disease control rate | up to approximately 16 months | Disease control rate |
Countries
China
Outcome results
None listed