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NCT07318636Not yet recruitingPhase 1

NK-cell Therapy Combined With PD-1 Antibody and Platinum-Based Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC

An Open-Label, Single-Arm Study Evaluating the Safety and Efficacy of NK010 Cell Injection Combined With PD-1 Antibody and Platinum-Based Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 6 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
10 (estimated)
First submitted
16 Dec 2025
Start date
20 Jan 2026
Primary completion date
30 Dec 2026
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Diseases
Lung cancer
NCT number
NCT07318636

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 10
  • From 20 Jan 2026 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior receipt of any systemic anticancer therapy.
  • Major cardiovascular events, unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.

Other illness

  • Active, known, or suspected autoimmune disease.
  • Interstitial lung disease.
  • Any other condition judged by the investigator to make the participant unsuitable for clinical trial participation.

Lab values

  • Known sensitizing EGFR mutations or ALK gene rearrangements.
  • 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.

Other

  • Locally advanced unresectable or metastatic NSCLC.
  • Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use effective contraception during the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.