NCT06966583

NAD+ Supplement（NMN）With Radioimmunotherapy in Advanced NSCLC

Safety and Preliminary Efficacy Study of NAD+Supplements (NMN) Combined With Radioimmunotherapy in Advanced Non Small Cell Lung Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, single center (West China Hospital, Sichuan University) study aimed at investigating the safety and efficacy of NMN supplements combined with chemotherapy and radiation therapy for second-line and above treatment of advanced NSCLC.

Detailed description

This study is a prospective, phase I, dose exploration (NMN dose escalation) clinical trial of radiotherapy combined with immunotherapy for advanced non-small cell carcinoma. The aim is to evaluate the safety and efficacy of NAD supplementation combined with radiotherapy and immunotherapy (+/- chemotherapy) in 20 patients with advanced non-small cell carcinoma who failed first-line treatment.The patient received PD-1 inhibitor combined with radiation therapy for the primary lesion and/or metastatic site (excluding intracranial lesions), and orally took NAD+supplement NMN. Regular monitoring indicators include ORR and PFS of patients' radiation therapy lesions and other observed lesions, medication safety, biomarkers, and OS. Tolerance observation will be conducted using a 3+3 NMN dose escalation approach until dose limiting toxicity (DLT) is observed in at least 2 out of 3-6 subjects, or tolerance observation of the study treatment will be conducted。 3 cohorts with increasing dose levels:NMN12000 GeneHarbor:150mg,Oral administration, once a day;Second dose group: NMN12000 GeneHarbor:150mg,Oral administration, twice a day;Third dose group: NMN12000 GeneHarbor:150mg,Oral administration,3 times a day.

Conditions

• Solid Tumor
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NAD supplement	NAD supplement NMN：NMN12000 GeneHarbor
RADIATION	Radiotherapy	Low Dose Radiotherapy or Stereotactic Ablative Radiotherapy or Conventional Radiotherapy
DRUG	Immunotherapy	PD-1 inhibitor

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-06-30
• Completion: 2027-11-30
• First posted: 2025-05-12
• Last updated: 2025-05-12

Locations

1 site across 1 country: China