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

BPI-7711301

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

2021-04-30

2023-12-31

2024-02-29

Active (not recruiting)

Early phase I

369

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.

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2023-09-05