About this trial
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 criteria
Qualifiers
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).
Disqualifiers
Prior receipt of any systemic anticancer therapy.
Known sensitizing EGFR mutations or ALK gene rearrangements.
Active, known, or suspected autoimmune disease.
Interstitial lung disease.
Trial design
Treatments tested in this trial
- PD-1 antibody
- NK010
Treatment groups
Sponsors and collaborators
The First Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Shanghai NK Cell Technology Co., LTD
Collaborator