The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

September 20, 2025

Primary Completion Date

January 1, 2027

Study Completion Date

December 1, 2028

Conditions
NSCLCStereotactic Body Radiation Therapy (SBRT)Immunotherapy
Interventions
DRUG

Narlumosbart

Patients who have not received any systemic therapy will receive narlumosbart and bone target lesion SBRT in combination with first-line treatment immunotherapy and chemotherapy after screening eligible subjects. Narlumosbart, 120mg/time, subcutaneous injection, is administered every 4 weeks. For the treatment of SBRT for bone metastases, the dose of 24Gy/3F is used for spinal metastases, and 30Gy/5F or 35Gy/5F is used for non-spinal lesions. Chemotherapy combined with immune checkpoint inhibitor therapy was used in accordance with the guidelines. The primary endpoint is to assess the objective response rate of NSCLC patients with bone metastases from narlumosbart combined with SBRT and first-line chemotherapy and immunotherapy. The secondary endpoints include progression-free survival, overall survival and safety. Sample size calculation used the Simon Two-Stage method. 27 subjects will be enrolled in this project, considering the dropout rate of 10%.

All Listed Sponsors
lead

Fudan University

OTHER

NCT06738160 - The Efficacy and Safety of Narlumosbart in Combination With Stereotactic Body Radiation Therapy to Improve the Efficacy of First-line Chemotherapy Combined With Immunotherapy in Patients With Bone Metastases From Advanced Non-small Cell Lung Cancer | Biotech Hunter | Biotech Hunter