OncoMatch/Clinical Trials/NCT06097962
Safety and Efficacy of NK510 to Treat NSCLC
Is NCT06097962 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies multiple treatments including NK510 and Tislelizumab，atezolizumab or sugemalimab for nsclc.
Treatment: NK510 · Tislelizumab，atezolizumab or sugemalimab · NK510 · systemic therapy as selected by the investigator — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: ALK wild-type
Required: EGFR wild-type
Required: ROS1 wild-type
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy
Disease progression after ≥4 courses of PD-(L)1 blockade ± chemotherapy
Lab requirements
Blood counts
Neutrophils <1.5×10⁹/L; Platelets <75×10⁹/L; Hemoglobin <90 g/L
Kidney function
Serum creatinine >1.5×ULN or creatinine clearance <50 mL/min
Liver function
ALT >3×ULN (≥5×ULN in patients with liver metastasis); AST >3×ULN (≥5×ULN in patients with liver metastasis); TBIL >1.5×ULN or >2.5×ULN (3.0 mg/dL) in patients with Gilbert syndrome
Cardiac function
QTc interval >480 ms on 12-lead ECG at rest; NYHA cardiac function class ≥II or LVEF <50%; severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; clinically uncontrolled hypertension
Meeting any of the following laboratory criteria: Hematology: Neutrophils <1.5×10⁹/L; Platelets <75×10⁹/L; Hemoglobin <90 g/L. Liver function: ALT >3×ULN (≥5×ULN in patients with liver metastasis); AST >3×ULN (≥5×ULN in patients with liver metastasis); TBIL >1.5×ULN or >2.5×ULN (3.0 mg/dL) in patients with Gilbert syndrome. Renal function: Serum creatinine >1.5×ULN or creatinine clearance <50 mL/min. History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, grade III atrioventricular block); QTc interval >480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; NYHA cardiac function class ≥II or left ventricular ejection fraction (LVEF) <50%; clinically uncontrolled hypertension.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06097962 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-PD-1 therapy.
Does this trial require ALK?
Yes, ALK wild-type is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR wild-type is a required biomarker for enrollment.
Does this trial require ROS1?
Yes, ROS1 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages