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

PHASE3RecruitingINTERVENTIONAL
Enrollment

570

Participants

Timeline

Start Date

March 28, 2023

Primary Completion Date

April 30, 2028

Study Completion Date

November 30, 2029

Conditions
Non-Small Cell Lung CancerEGFR Sensitive MutationAdjuvant Therapy
Interventions
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."

Trial Locations (3)

Unknown

RECRUITING

Peking University International Hospital, Beijing

RECRUITING

Jiangsu Cancer Hospital, Nanjing

RECRUITING

Shanghai chest hospital, Shanghai

All Listed Sponsors
lead

Betta Pharmaceuticals Co., Ltd.

INDUSTRY