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Not yet recruiting NCT07318636

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

Phase I Interventional Resectable Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD-1 antibody, NK010.
Who it may be relevant to
Registry conditions: Resectable Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Participants with histologically or cytologically confirmed, resectable non-small cell lung cancer (NSCLC) will receive a neoadjuvant regimen consisting of NK010 cell injection, an anti-PD-1 antibody, and standard platinum-based doublet chemotherapy.

The primary objective of this study is to assess the safety and feasibility of this combination regimen in the preoperative setting. Secondary objectives include the exploration of potential antitumor activity. The study utilizes a sequential dose-escalation design, with NK010 administered at three planned dose levels.

Following neoadjuvant therapy and surgical resection, postoperative adjuvant therapy will be administered at the investigator's discretion in accordance with standard clinical practice.

Interventions

  • Drug 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.
  • Biological 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.

Primary outcome measures

  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to 1 year after first dose of NK010]
  • Dose Limiting Toxicities (DLTs) [Time frame: Up to 21 days after first dose of NK010]
Secondary outcome measures (4)
  • Major pathological response (MPR) [Time frame: Within 6 weeks after completion of neoadjuvant therapy]
  • Pathological complete response (pCR) [Time frame: Within 6 weeks after completion of neoadjuvant therapy]
  • R0 Resection Rate [Time frame: Within 6 weeks after completion of neoadjuvant therapy]
  • Objective Response Rate (ORR) [Time frame: Up to preoperative assessment (approximately 12 weeks from treatment initiation)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou

Identifiers

NCT: NCT07318636 · NK010-IIT-NSCLC-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗