NCT06955325

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

A Randomized, Phase III Umbrella Trial of Adjuvant Therapy Versus Observation in Completely Resected High-Risk Stage IA-IB Non-Small Cell Lung Cancer Based on Oncogenic Driver Mutations

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study explores how adjuvant therapy affects survival in completely resected high-risk stage IA-IB NSCLC patients with different driver gene mutations.

Detailed description

This study aims to evaluate whether tailored, targeted therapy or immunotherapy can effectively prevent cancer recurrence in patients with early-stage (stage IA-IB) non-small cell lung cancer (NSCLC) who have undergone complete surgical resection but are at high risk of recurrence. Based on each patient's specific driver gene mutation status (e.g., EGFR or ALK/ROS1) or wild-type status, participants will receive either targeted therapy or immunotherapy compared to routine follow-up (observation). The goal is to see if these approaches can improve disease-free survival and potentially reduce the risk of lung cancer recurrence.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2030-12-01
• Completion: 2035-12-01
• First posted: 2025-05-02
• Last updated: 2025-05-06