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

Guangzhou Medical University

Status and phase: Not yet enrolling; Phase 1

Conditions: Resectable Non-small Cell Lung Cancer

Treatments: Drug: PD-1 antibody; Biological: NK010

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07318636

NK010-IIT-NSCLC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

NK010 + PD-1 Antibody + Platinum-Based Chemotherapy

Experimental group

Description:

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.

Treatment:

Biological: NK010

Drug: PD-1 antibody