Safety and Efficacy of NK510 to Treat NSCLC
NCT06097962 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-05-20
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
Interventions
- 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
Sponsors & Collaborators
-
Jinling Hospital, China
collaborator OTHER -
Base Therapeutics (Shanghai) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Tangfeng Lv, PhD · Jinling hospital, Nanjing, China
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-01
- Primary Completion
- 2026-07-01
- Completion
- 2026-07-01
Countries
- China
Study Locations
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