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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Resectable Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: PD-1 antibody; Biological: NK010

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wenhua Liang, MD; Phone Number: 020-83062807; Email: liangwh@gird.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • The First Affiliated Hospital of Guangzhou Medical University
      • Principal Investigator: Jianxing He, MD
      • Contact: Wenhua Liang, MD; Phone Number: 020-83062807; Email: liangwh@gird.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NK010 + PD-1 Antibody + Platinum-Based Chemotherapy; Participants will receive neoadjuvant therapy for a total of 3 cycles, with each cycle lasting 3 weeks. NK010 cell injection will be administered in combination with a PD-1 antibody and platinum-based chemotherapy. After completing 3 cycles of treatment, participants will undergo surgical resection, followed by pathological assessment to evaluate outcomes such as major pathological response (MPR), pathological complete response (pCR), and R0 resection rate. NK010 administration will be evaluated at three planned dose levels.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 1 year after first dose of NK010
Dose Limiting Toxicities (DLTs)	Identification of DLTs to determine the maximum tolerated dose (MTD).	Up to 21 days after first dose of NK010

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major pathological response (MPR)	The MPR rate will be reported as the proportion of participants achieving MPR among all participants who undergo surgical resection.	Within 6 weeks after completion of neoadjuvant therapy
Pathological complete response (pCR)	The pCR rate will be reported as the proportion of participants achieving pCR among all participants who undergo surgical resection.	Within 6 weeks after completion of neoadjuvant therapy
R0 Resection Rate	The proportion of participants who achieve complete surgical tumor resection	Within 6 weeks after completion of neoadjuvant therapy
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.	Up to preoperative assessment (approximately 12 weeks from treatment initiation)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Collaborators: Shanghai NK Cell Technology Co., LTD

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; spartalizumab
• Other Study ID Numbers: NK010-IIT-NSCLC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No