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.
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).
Prior receipt of any systemic anticancer therapy.
Known sensitizing EGFR mutations or ALK gene rearrangements.
Active, known, or suspected autoimmune disease.
Interstitial lung disease.
Single group
PD-1 antibody
DrugThe PD-1 antibody will be administered intravenously in combination with NK010 cell injection and platinum-based chemotherapy during the neoadjuvant treatment phase.
NK010
Biological/VaccineNK010 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.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
Identification of DLTs to determine the maximum tolerated dose (MTD).
Major pathological response (MPR)
The MPR rate will be reported as the proportion of participants achieving MPR among all participants who undergo surgical resection.
Pathological complete response (pCR)
The pCR rate will be reported as the proportion of participants achieving pCR among all participants who undergo surgical resection.
R0 Resection Rate
The proportion of participants who achieve complete surgical tumor resection
Objective Response Rate (ORR)
ORR is defined as the proportion of participants achieving a complete response (CR) or partial response (PR) according to RECIST v1.1 criteria, as assessed by radiologic imaging after completion of neoadjuvant therapy.
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The First Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Shanghai NK Cell Technology Co., LTD
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
