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Tests treatment safety and results for NSCLC
Official title Safety and Efficacy of NK510 to Treat NSCLC
ClinicalTrials.gov ID: NCT06097962
What this study is testing
What is NK510?
NK510 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nsclc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For pleural perfusion group (Group D1/D2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with...
- At least one CT or MRI measurable lesion according to RECIST v1.1.
- ECOG performance status 0-2.
You likely can't join if
- Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases...
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities...
- Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within...
- Systemic treatment with corticosteroids (prednisone \>10 mg/day or equivalent) or other immunosuppressive/immunomodulatory drugs (e.g., thymosin...
- Known allergy or intolerance to PD-(L)1 blockade.
See the full eligibility 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...
- 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) or baseline; people with long-term sequelae from previous therapy (e.g., neuropathy after platinum-based...
- Fertile females must be non-lactating and have a negative serum pregnancy test within 1 week before enrollment; all people (male or female) must agree to use contraception from signing informed consent until 6 months...
- Able to comply with the study protocol and follow-up procedures.
- Voluntarily sign the informed consent form.
- Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment [e.g., vitiligo, psoriasis, alopecia]...
- 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...
- Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within 2 weeks before enrollment.
- Systemic treatment with corticosteroids (prednisone \>10 mg/day or equivalent) or other immunosuppressive/immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment; inhalation...
- Known allergy or intolerance to PD-(L)1 blockade.
- 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.
- Any other severe or uncontrollable medical diseases, active infections, physical examination abnormalities, laboratory test abnormalities, mental status changes or mental illnesses that increase subject risk or affect...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.