The First Affiliated Hospital of Guangzhou Medical University
Phase
Phase 1
Started
2026-01-20
Last updated
2026-01-06
Condition(s) studied
Resectable Non-small Cell Lung Cancer
Investigational drug(s) / intervention(s)
PD-1 antibodyNK010
PD-1 antibody: The PD-1 antibody will be administered intravenously in combination with NK010 cell injection and platinum-based chemotherapy during the neoadjuvant treatment phase.
NK010: NK010 is an allogeneic, off-the-shelf natural killer (NK) cell product derived from peripheral blood. NK010 will be administered intravenously in combination with a PD-1 antibody and platinum-based chemotherapy during the neoadjuvant treatment phase.
Study summary
This open-label, single-arm study is designed to evaluate the safety and preliminary efficacy of NK010 cell injection combined with a PD-1 antibody and platinum-based chemotherapy as neoadjuvant therapy in patients with resectable non-small cell lung cancer (NSCLC). The study aims to assess the safety profile, feasibility of administration, and potential antitumor activity of this combination regimen.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Able to understand and voluntarily sign the written informed consent form (ICF).
* Male or female patients aged ≥18 years.
* Histologically and/or cytologically confirmed resectable stage IB to IIIA non-small cell lung cancer (NSCLC) according to AJCC 8th edition.
* Treatment-naïve NSCLC (no prior systemic anticancer therapy).
* No sensitizing EGFR mutations (exon 19 deletion, exon 21 L858R) and no ALK gene rearrangement.
* At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Estimated life expectancy of more than 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Adequate bone marrow, liver, and renal function.
* Female participants of childbearing potential must have a negative pregnancy test prior to initiation of study treatment.
Exclusion Criteria:
* Prior receipt of any systemic anticancer therapy.
* Known sensitizing EGFR mutations or ALK gene rearrangements.
* Active, known, or suspected autoimmune disease.
* Interstitial lung disease.
* Any medical condition, therapy, or laboratory abnormality that, in the opinion of the investigator, could confound the study results, interfere with the participant's ability to comply with study procedures, or is not in the best interest of the participant.
* Locally advanced unresectable or metastatic NSCLC.
* Major cardiovascular events, unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use effective contraception during the study.
* Any other condition judged by the investigator to make the participant unsuitable for clinical trial participation.
Primary outcome measure(s)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) — Up to 1 year after first dose of NK010 Number of subjects experiencing adverse events, and the frequency and severity of adverse events. The type, frequency, onset, and severity of treatment-emergent adverse events (TEAEs) will be assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Dose Limiting Toxicities (DLTs) — Up to 21 days after first dose of NK010 Identification of DLTs to determine the maximum tolerated dose (MTD).
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Guangdong
More The First Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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