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

NCT07318636 | Not Yet Recruiting Phase 1

• 1 other identifier: NK010-IIT-NSCLC-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resectable Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Major pathological response (MPR)

  Within 6 weeks after completion of neoadjuvant therapy

• Pathological complete response (pCR)

  Within 6 weeks after completion of neoadjuvant therapy

• R0 Resection Rate

  Within 6 weeks after completion of neoadjuvant therapy

• Objective Response Rate (ORR)

  Up to preoperative assessment (approximately 12 weeks from treatment initiation)

Study Arms (1)

NK010 + PD-1 Antibody + Platinum-Based Chemotherapy

EXPERIMENTAL

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; Biological: NK010

Interventions

PD-1 antibody DRUG

The PD-1 antibody will be administered intravenously in combination with NK010 cell injection and platinum-based chemotherapy during the neoadjuvant treatment phase.

NK010 + PD-1 Antibody + Platinum-Based Chemotherapy

NK010 BIOLOGICAL

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.

NK010 + PD-1 Antibody + Platinum-Based Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wenhua Liang, MD

CONTACT

020-83062807; liangwh@gird.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Guangzhou Institute of Respiratory Health

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 6, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)