NCT06097962

Safety and Efficacy of NK510 to Treat NSCLC

Exploratory Study of NK510 Combined With PD-1 Blockade in the Treatment of Relapsed and Refractory Advanced NSCLC

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Base Therapeutics (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	NK510	Intravenous infusion
DRUG	Tislelizumab，atezolizumab or sugemalimab	Administer according to the instructions
DRUG	NK510	intrapleural infusion
DRUG	systemic therapy as selected by the investigator	Administer according to the instructions

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-10-24
• Last updated: 2026-03-20

Locations

1 site across 1 country: China