Resectable Non-small Cell Lung CancerPhase 1NCT07318636
NK-cell Therapy Combined With PD-1 Antibody and Platinum-Based Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC
A Phase 1 study testing PD-1 antibody and NK010 in people with Resectable Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Non-small Cell Lung Cancer
- What is being tested?
- PD-1 antibody and NK010
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Wenhua Liang, MD, 020-83062807, liangwh@gird.cn
Jianxing He, MD
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Resectable Non-small Cell Lung Cancer
- Being tested
- PD-1 antibody, NK010
- Keywords
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
The PD-1 antibody will be administered intravenously in combination with NK010 cell injection and platinum-based chemotherapy during the neoadjuvant treatment phase.
NK010Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: PD-1 antibody; Biological: NK010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year after first dose of NK010
Dose Limiting Toxicities (DLTs)
Identification of DLTs to determine the maximum tolerated dose (MTD).
Measured: Up to 21 days after first dose of NK010
Secondary outcomes (4)
Major pathological response (MPR)
The MPR rate will be reported as the proportion of participants achieving MPR among all participants who undergo surgical resection.
Measured: 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.
Measured: Within 6 weeks after completion of neoadjuvant therapy
R0 Resection Rate
The proportion of participants who achieve complete surgical tumor resection
Measured: 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.
Measured: Up to preoperative assessment (approximately 12 weeks from treatment initiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai NK Cell Technology Co., LTD
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318636
- Sponsor's protocol ID
- NK010-IIT-NSCLC-01
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07318636
- Acronym / sponsor ID
- NK010-IIT-NSCLC-01
- Conditions
- Resectable Non-small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai NK Cell Technology Co., LTD
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK010 + PD-1 Antibody + Platinum-Based Chemotherapy | Experimental | Drug: PD-1 antibody, Biological: NK010Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD-1 antibodyThe PD-1 antibody will be administered intravenously in combination with NK010 cell injection and platinum-based chemotherapy during the neoadjuvant treatment phase. | Drug | NK010 + PD-1 Antibody + Platinum-Based Chemotherapy |
| NK010NK010 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. | Biological | NK010 + PD-1 Antibody + Platinum-Based Chemotherapy |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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)
Time frame: Up to 21 days after first dose of NK010
Identification of DLTs to determine the maximum tolerated dose (MTD).
4 secondary outcomes
Major pathological response (MPR)
Time frame: Within 6 weeks after completion of neoadjuvant therapy
Pathological complete response (pCR)
Time frame: Within 6 weeks after completion of neoadjuvant therapy
R0 Resection Rate
Time frame: Within 6 weeks after completion of neoadjuvant therapy
Objective Response Rate (ORR)
Time frame: Up to preoperative assessment (approximately 12 weeks from treatment initiation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PD-1 antibody and NK010 in people with Resectable Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhua Liang, MD (020-83062807, liangwh@gird.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 1 year after first dose of NK010). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.