NCT07231575

Neoadjuvant SBRT and Tislelizumab (Immunotherapy) Plus Anlotinib for Resectable EGFR Wild-type NSCLC

Preoperative Stereotactic Body Radiotherapy and Tislelizumab (Immunotherapy) Plus Anlotinib for Operable Stage IB to III EGFR Wild-type Non-small Cell Lung Cancer（STATION）

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The neoadjuvant strategy of immunotherapy combined with chemotherapy has been recommended for resectable or potentially resectable tumors without driver-gene alterations.However, the AE of chemotherapy is more than 40%，which bring fear to the patients，especially for those who cannot tolerate or refuse chemotherapy.Several studies indicated that the strategies of chemo-free ,such as the combination of immunotherapy with antiangiogenic therapy or with SBRT, were safe and well tolerated, without increasing adverse reactions. Both of them have a promising efficacy with a manageable toxicity profile in patients with resectable NSCLC. The investigators aim to assess the activity and safety of neoadjuvant SBRT and immunotherapy plus antiangiogenic therapy in patients with resectable NSCLC.

Conditions

• Neoadjuvant Immunotherapy
• NSCLC
• Chemo-free Therapy

Interventions

Type	Name	Description
RADIATION	SBRT	SBRT 8Gy\*3
DRUG	Immunotherapy	Tislelizumab (immunotherapy) 200mg Q3W
DRUG	antiangiogenesis therapy	Anlotinib 8mg D1-D14 Q3W

Timeline

• Start date: 2025-11-10
• Primary completion: 2027-11-30
• Completion: 2032-05-30
• First posted: 2025-11-17
• Last updated: 2025-11-18