Clinical Trial: NCT03866499
A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients
Status:
UNKNOWNPhase:
Phase 3| Lead Sponsor: | Beta Pharma Shanghai |
| Information Provided By: | Beta Pharma, Inc. |
| Last Update Posted: | 2024-08-07 |
Study Overview
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
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
Conditions
NSCLC
Intervention / Treatment
- Drug: BPI-7711
- Drug: Gefitinib
- Drug: Placebo Tablet
- Drug: Placebo capsule
Other Study ID Numbers
- BPI-7711301
Start Date (Actual)
2021-04-30
Primary Completion Date (Actual)
2023-11-30
Study Completion Date (Estimated)
2025-12-30
Enrollment (Actual)
369
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Beta Pharma Shanghai |
| Information Provided By: | Beta Pharma, Inc. |
| Last Update Posted: | 2024-08-07 |
Study Overview
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
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
Conditions
NSCLC
Intervention / Treatment
- Drug: BPI-7711
- Drug: Gefitinib
- Drug: Placebo Tablet
- Drug: Placebo capsule
Other Study ID Numbers
- BPI-7711301
Start Date (Actual)
2021-04-30
Primary Completion Date (Actual)
2023-11-30
Study Completion Date (Estimated)
2025-12-30
Enrollment (Actual)
369
Study Type
Interventional
Phase
Phase 3