A Phase 1 interventional study of PD-1 antibody and NK010 in Resectable Non-small Cell Lung Cancer, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 1, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 10 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
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
The PD-1 antibody will be administered intravenously in combination with NK010 cell injection and platinum-based chemotherapy during the neoadjuvant treatment phase.
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.
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.
Time frame: Up to 1 year after first dose of NK010
Dose Limiting Toxicities (DLTs)
Identification of DLTs to determine the maximum tolerated dose (MTD).
Time frame: Up to 21 days after first dose of NK010
Major pathological response (MPR)
The MPR rate will be reported as the proportion of participants achieving MPR among all participants who undergo surgical resection.
Time frame: 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.
Time frame: Within 6 weeks after completion of neoadjuvant therapy
R0 Resection Rate
The proportion of participants who achieve complete surgical tumor resection
Time frame: 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.
Time frame: Up to preoperative assessment (approximately 12 weeks from treatment initiation)
Plan to share: No
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
The First Affiliated Hospital of Guangzhou Medical University