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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Биопрепарат 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.

Первичные конечные точки

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 1 year after first dose of NK010]
• Dose Limiting Toxicities (DLTs) [Срок оценки: Up to 21 days after first dose of NK010]

Вторичные конечные точки (4)

• Major pathological response (MPR) [Срок оценки: Within 6 weeks after completion of neoadjuvant therapy]
• Pathological complete response (pCR) [Срок оценки: Within 6 weeks after completion of neoadjuvant therapy]
• R0 Resection Rate [Срок оценки: Within 6 weeks after completion of neoadjuvant therapy]
• Objective Response Rate (ORR) [Срок оценки: Up to preoperative assessment (approximately 12 weeks from treatment initiation)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу

Идентификаторы

NCT: NCT07318636 · NK010-IIT-NSCLC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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