Umbrella Trial of Adjuvant Therapy in Completely Resected High-risk Stage IA-IB NSCLC: Focus on Driver Mutations

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

May 31, 2025

Primary Completion Date

December 31, 2030

Study Completion Date

December 31, 2035

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Icotinib

Oral icotinib tablets (125 mg) administered three times daily (TID) for up to 1 year or until disease recurrence or unacceptable toxicity. Icotinib is an EGFR tyrosine kinase inhibitor targeting EGFR-sensitizing mutations.

DRUG

Rezivertinib

Oral rezivertinib capsules (100 mg) taken once daily (QD) for up to 1 year or until disease recurrence or unacceptable toxicity. Rezivertinib is an EGFR tyrosine kinase inhibitor targeting EGFR-sensitizing mutations.

DRUG

Ensartinib

Oral ensartinib capsules (225 mg) taken once daily (QD) for up to 1 year or until disease recurrence or unacceptable toxicity. Ensartinib is an ALK/ROS1 tyrosine kinase inhibitor designed to inhibit ALK/ROS1 fusion-driven NSCLC.

DRUG

Benmelstobart

Intravenous infusion of bemosumab 1200 mg every 3 weeks (Q3W). Treatment continues for up to 4 cycles initially, and may be extended (maintenance) for up to 3 years or until disease recurrence or unacceptable toxicity. Bemosumab is a monoclonal antibody under investigation for immunotherapy in NSCLC.

All Listed Sponsors
lead

The First Affiliated Hospital of Guangzhou Medical University

OTHER