Resectable Non-small Cell Lung Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer
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.
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
DRUGPD-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.
BIOLOGICALNK010
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.
Sponsors
Shanghai NK Cell Technology Co., LTD
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 1 year after first dose of NK010 | 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. |
| Dose Limiting Toxicities (DLTs) | Up to 21 days after first dose of NK010 | Identification of DLTs to determine the maximum tolerated dose (MTD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major pathological response (MPR) | Within 6 weeks after completion of neoadjuvant therapy | The MPR rate will be reported as the proportion of participants achieving MPR among all participants who undergo surgical resection. |
| Pathological complete response (pCR) | Within 6 weeks after completion of neoadjuvant therapy | The pCR rate will be reported as the proportion of participants achieving pCR among all participants who undergo surgical resection. |
| R0 Resection Rate | Within 6 weeks after completion of neoadjuvant therapy | The proportion of participants who achieve complete surgical tumor resection |
| Objective Response Rate (ORR) | Up to preoperative assessment (approximately 12 weeks from treatment initiation) | 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. |
Countries
China
Contacts
Primary ContactWenhua Liang, MD
Outcome results
None listed