NCT06041776

Adjuvant Befotertinib in Stage IB-IIIB Non-small Cell Lung Cancer With Positive EGFR Sensitive Mutations

A Multicenter, Randomized, Controlled, Double Blind, Double Simulated, Phase III Clinical Study of Befotertinib vs Icotinib for Postoperative Adjuvant Treatment of IB-IIIB (T3N2M0) Stage Non Small Cell Lung Cancer With Positive EGFR Sensitive Mutations

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 570 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, controlled, double-blind, double-simulated, Phase III study is designed to evaluate the efficacy and safety of Befotertinib compared with Icotinib as adjuvant treatment in EGFR-sensitive mutation-positive stage IB-IIIB (T3N2M0) non-small cell lung cancer after surgical resection.

Conditions

• Non-Small Cell Lung Cancer
• EGFR Sensitive Mutation
• Adjuvant Therapy

Interventions

Type	Name	Description
DRUG	Befotertinib + Icotinib placebo	The initial dose of Befotertinib is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis) Icotinib placebo 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis).
DRUG	Icotinib + Befotertinib placebo	Icotinib 125 mg three times daily, on an empty stomach or in combination with food, use medication until the disease relapses or intolerable toxicity occurs or treatment lasts for 2 years (disease recurrence includes local recurrence and/or distant metastasis). The initial dose of Befotertinib placebo is 75 mg orally once daily (QD) for 21 days, and then increased to 100 mg orally QD in the absence of serious side effects , CTCAE grade ≥ 2 headache or thrombocytopenia during the 21 days. Befotertinib placebo can be taken on an empty stomach or after meals, and the medication is used until the disease relapses or intolerable toxicity occurs, or the treatment lasts for 3 years (disease recurrence includes local recurrence and/or distant metastasis.

Timeline

• Start date: 2023-03-28
• Primary completion: 2028-04-30
• Completion: 2029-11-30
• First posted: 2023-09-18
• Last updated: 2023-09-22

Locations

3 sites across 1 country: China