Safety and Efficacy of NK510 to Treat NSCLC
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 E
| Condition(s) | NSCLC |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Age ≥ 18 years, male or female. * For dose expansion group (Group A/B/C): A. EGFR mutation-negative, ROS1-negative, and ALK-negative; unresectable and non-radiotherapeutic stage III or IV, locally advanced, recurrent or metastatic NSCLC. B. Disease progression after ≥4 courses of PD-(L)1 blockade ± chemotherapy. * For pleural perfusion group (Group D1/D2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with driver gene-positive and resistant to targeted therapy are acceptable. * At least one CT or MRI measurable lesion according to RECIST v1.1. * ECOG performance status 0-2. * Expected survival ≥3 months. * All toxicities from previous anti-tumor therapy (except alopecia and fatigue) resolved to grade 1 (CTCAE v5.0) o |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Base Therapeutics (Shanghai) Co., Ltd. |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2023-07-01 |
| NCT ID | NCT06097962 |
| Official listing | https://clinicaltrials.gov/study/NCT06097962 |