NCT05007938

Befotertinib and Icotinib in Treatment-naive Patients With Advanced EGFR-Mutant Lung Cancer

A Phase II, Single Arm, Study to Assess Befotertinib and Icotinib as First-Line Treatment in Patients With Locally Advanced or Metastatic NSCLC and Sensitising EGFR Mutation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a combination of two drugs as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation.

Detailed description

This is a phase II, single-arm study assessing the safety and efficacy of befotertinib (25mg three times daily, orally）combining with icotinib (125mg three times daily, orally) in patients with locally advanced or metastatic NSCLC that is known to be EGFR sensitising mutation (EGFRm) positive, treatment-naive and eligible for first-line treatment with an EGFR-TKI.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Icotinib	Icotinib is a EGFR ihibitior.
DRUG	Befotertinib	An orally available, irreversible, third-generation，mutant-selective epidermal growth factor receptor（EGFR）inhibitor. Befotertinib combine with icotinib means that both drugs will be given together until disease progression or meet the discontinuation criteria.

Timeline

• Start date: 2021-08-12
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-08-17
• Last updated: 2024-08-23

Locations

1 site across 1 country: China