Small Cell Lung CancerPhase 2NK-ICI-SCLCNCT07759856
NK Cells Plus ICI for SCLC Maintenance
A Phase 2 study testing Allogeneic Natural Killer Cells and Immune Checkpoint Inhibitor in people with Small Cell Lung Cancer, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
This research study is designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have already received four cycles of standard chemotherapy, with at least two cycles combined with immunotherapy, and have achieved disease control (stable disease, partial response, or complete response) at their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Allogeneic Natural Killer Cells and Immune Checkpoint Inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Aug 2029
- Phase
- Phase 2
- 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
- 1: Male or female, aged 18 years or above
- 2: ECOG score 0-2
- 3: metastatic or extensive-stage small cell lung cancer (SCLC) confirmed by histology or cytology, followed by 4 cycles of platinum-based doublet-chemotherapy with at least 2 cycles of immune checkpoint inhibitor plus chemotherapy. And stable disease (SD), partial response (PR), or complete response (CR) as assessed by imaging (RECIST1.1 criteria) after the last treatment. (The checkpoint inhibitors used were those recommended by the NCCN, ESMO, and CSCO guidelines for extensivestage SCLC, including but not limited to: Duvalumab, atezolizumab, slulizumab, adbelimumab, toripalimab, etc.)
- 4: After standard concurrent chemoradiotherapy, LS-SCLC could be enrolled in this study if sensitive relapse (relapse more than 6 months after the end of first-line treatment) progressed to extensive-stage (Ed) and met the inclusion criteria No.3;
- 5: At least 4 weeks after major surgery or trauma, and the wound must be completely healed; At least 1 week after minor surgical procedures or trauma (e.g., tissue biopsy or fine-needle aspiration);
- 6: Objective measurable lesions according to RECIST 1.1 criteria;
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- 7: predicted survival time ≥1 year;
- 8: bone marrow function: ANC≥1.5×109/L, HB≥70 g/L (blood transfusion allowed), PLT≥80×109/L;
- 9: Liver function: ALT≤3×ULN, AST≤3×ULN, TBIL≤2×ULN (patients with liver metastasis ALT≤5×ULN, AST≤5×ULN, TBIL≤2×ULN) Child-Pugh score ≤7; Renal function: uric acid <500 μmol/L, serum creatinine <1.7 mg/dL, proteinuria ≤2+ or ≤2g/24h, glomerular filtration rate (GFR) ≥60 ml/min/1.73m2;
- 10: no history of autoimmune diseases or current autoimmune diseases;
- 11: The subjects voluntarily participated in the study, signed the informed consent form, communicated well with the investigators, and completed the study in accordance with the protocol.
Who cannot join
- 1:Participate in other clinical trials or use other research drugs or equipment within 4 weeks of the first treatment.
- 2: During the screening period and previous imaging evaluation, active or untreated CNS metastasis was found by CT scanning or MRI. Patients with asymptomatic CNS metastasis who had been treated in the past can participate in this study as long as they meet all the following criteria: corticosteroids are not needed to treat CNS diseases, and imaging examination has not found any progress from the end of CNS directional treatment to the screening period。 If new asymptomatic CNS metastases are found in patients during the screening period, they must undergo radiotherapy and/or CNS metastasis surgery
- 3: The effusion in the third space with clinical symptoms needs repeated drainage (for example, less than once every four weeks), such as pericardial effusion, pleural effusion and peritoneal effusion that are still uncontrollable after pumping or other treatments
- 4: Live vaccine was inoculated within 30 days before the first administration of the study drug. Live vaccines include but are not limited to measles, mumps, minute needle, chickenpox/herpes zoster, rabies, BCG, typhoid vaccine, etc. Seasonal influenza vaccine for injection is generally inactivated virus vaccine, which is allowed to be used.
- 5: The patient is known to have other malignant tumors, which are progressing or need active treatment in the past 3 years (except for in situ cancer or localized prostate cancer supplemented by PSA test)
- 6: Received major surgery, open surgical biopsy or severe traumatic injury 28 days before joining the group.
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- 7: Clinically related or preexisting interstitial lung disease
- 8: Severe unhealed wound, ulcer or fracture
- 9: Suffering from autoimmune diseases requiring systemic treatment in the past 2 years
- 10: Unstable systemic concomitant diseases (active infection, moderate and severe chronic obstructive pulmonary disease, poorly controlled hypertension, unstable angina pectoris, congestive heart failure, myocardial infarction, cerebrovascular accident, pulmonary embolism or untreated history of Grade 3 deep vein thrombosis (DVT) within 6 months, serious mental disorder requiring drug control, liver, kidney or other metabolic diseases, neuropsychiatric diseases such as Alzheimer's disease).
- 11: According to the judgment of the researcher, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
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, 1 recruiting
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300192
Wang, 02223626600
About this study
Official title: A Randomized, Controlled, Open and Exploratory Clinical Trial of Immunization Combined With Allogeneic NK Cells in the Immune Maintenance Stage After First-line Treatment of Extensive Small Cell Lung Cancer
This research study is designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have already received four cycles of standard chemotherapy, with at least two cycles combined with immunotherapy, and have achieved disease control (stable disease, partial response, or complete response) at their last efficacy evaluation.
In this study, participants will be randomly assigned to one of two groups:
Read more
Group A will receive standard immunotherapy plus 1 to 3 courses of allogeneic natural killer (NK) cell therapy. Each course consists of six NK cell infusions given over 28 days.
Group B will receive standard immunotherapy alone. All participants will continue treatment until their disease progresses or they experience unacceptable side effects. The immunotherapy agents used in this study are those recommended by major international and national clinical guidelines for extensive-stage SCLC, including but not limited to durvalumab, atezolizumab, serplulimab, and adebrelimab.
The purpose of this study is to evaluate whether adding NK cell therapy to standard immunotherapy can provide additional benefits for patients with extensive-stage SCLC who have responded well to initial treatment.
Read the detailed description
This is a prospective study enrolling 42 patients with extensive-stage small cell lung cancer (ES-SCLC) who have completed four cycles of platinum-based doublet chemotherapy, with at least two cycles of immunotherapy combined with platinum-based doublet chemotherapy, and whose final efficacy assessment after the last cycle shows disease control (SD, PR, or CR). Patients will be adaptively randomized into two groups based on the results of prior efficacy analysis. Subjects will be randomly assigned to Group A or Group B. Patients in Group A will receive an immune checkpoint inhibitor (ICI) plus 1-3 courses of allogeneic natural killer (NK) cell therapy. One course of NK cell therapy is designed to consist of two cycles, with a total of six NK cell infusions within 28 days, specifically on Days 12, 13, and 14 of the first cycle and Days 26, 27, and 28 of the second cycle. In addition, on Day 1 of each 21-day cycle, patients will receive standard-of-care treatment with intravenous infusion of an immune checkpoint inhibitor. Patients in Group B will receive standard-of-care treatment with intravenous infusion of an immune checkpoint inhibitor on Day 1 of each 21-day cycle, and treatment will continue until disease progression or unacceptable toxicity occurs. After signing the written informed consent form, patients will receive study treatment per protocol until disease progression or intolerable adverse events develop. The immune checkpoint inhibitors used in this study are those recommended for extensive-stage SCLC in the NCCN, ESMO, and CSCO guidelines, including but not limited to durvalumab, atezolizumab, serplulimab, and adebrelimab.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Allogeneic Natural Killer Cells, Immune Checkpoint Inhibitor
- Keywords
- Extensive-Stage Small Cell Lung Cancer, Immunotherapy, Allogeneic NK Cells, Natural Killer Cells, Maintenance Therapy, Randomized Controlled Trial
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Natural Killer CellsBiological
Allogeneic NK cells derived from healthy donors, expanded and activated ex vivo. One course consists of two cycles with 6 IV infusions over 28 days: Days 12, 13, 14 (Cycle 1) and Days 26, 27, 28 (Cycle 2). Patients receive 1-3 courses.
Immune Checkpoint InhibitorDrug
Immune checkpoint inhibitors recommended for extensive-stage SCLC by NCCN, ESMO, and CSCO guidelines, including but not limited to durvalumab, atezolizumab, serplulimab, adebrelimab, and toripalimab. Administered as IV infusion on Day 1 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| ICI + Allogeneic NK Cells | Experimental | Not described Receives: Biological: Allogeneic Natural Killer Cells; Drug: Immune Checkpoint Inhibitor |
| ICI Alone | Active comparator | Not described Receives: Drug: Immune Checkpoint Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: Every 6 weeks from randomization until disease progression or death, up to approximately 24 months
Duration of Overall Response
Measured: From first documented response to disease progression, assessed every 6 weeks up to 24 months
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Measured: From first dose through 30 days after last dose, up to approximately 24 months
Secondary outcomes (5)
overall survival
Measured: From randomization to death from any cause, assessed up to 24 months
Change from baseline in peripheral blood lymphocyte subsets (CD3+CD4+, CD3+CD8+, total CD3+, CD3-CD19+, and CD3-CD16+CD56+ cells) at Day 90
Measured: Baseline and Day 90
Change from baseline in serum cytokine levels (IL-2, IL-4, IL-6, IL-10, TNF-β, and IFN-γ) at Day 90
Measured: Baseline and Day 90
Change from baseline in serum tumor markers (SCC) at Day 90
Measured: Baseline and Day 90
Change from baseline in peripheral blood NK cell activity at Day 90
Measured: Baseline and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients receive immune checkpoint inhibitor plus 1-3 courses of allogeneic natural killer (NK) cell therapy. Each course consists of 6 NK cell infusions over 28 days, combined with standard ICI on Day 1 of each 21-day cycle.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Zhao, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759856
- Sponsor's protocol ID
- XYZ-NK-SCLC-001
- Acronym
- NK-ICI-SCLC
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the research process, the research team chooses specific ways to disclose the original data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open and Exploratory Clinical Trial of Immunization Combined With Allogeneic NK Cells in the Immune Maintenance Stage After First-line Treatment of Extensive Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07759856
- Acronym / sponsor ID
- NK-ICI-SCLC / XYZ-NK-SCLC-001
- Conditions
- Small Cell Lung Cancer
- Keywords
- Extensive-Stage Small Cell Lung Cancer, Immunotherapy, Allogeneic NK Cells, Natural Killer Cells, Maintenance Therapy, Randomized Controlled Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 12 Aug 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 research study is designed for patients with extensive-stage small cell lung cancer (ES-SCLC) who have already received four cycles of standard chemotherapy, with at least two cycles combined with immunotherapy, and have achieved disease control (stable disease, partial response, or complete response) at their last efficacy evaluation.
In this study, participants will be randomly assigned to one of two groups:
Group A will receive standard immunotherapy plus 1 to 3 courses of allogeneic natural killer (NK) cell therapy. Each course consists of six NK cell infusions given over 28 days.
Group B will receive standard immunotherapy alone. All participants will continue treatment until their disease progresses or they experience unacceptable side effects. The immunotherapy agents used in this study are those recommended by major international and national clinical guidelines for extensive-stage SCLC, including but not limited to durvalumab, atezolizumab, serplulimab, and adebrelimab.
The purpose of this study is to evaluate whether adding NK cell therapy to standard immunotherapy can provide additional benefits for patients with extensive-stage SCLC who have responded well to initial treatment.
Detailed description
This is a prospective study enrolling 42 patients with extensive-stage small cell lung cancer (ES-SCLC) who have completed four cycles of platinum-based doublet chemotherapy, with at least two cycles of immunotherapy combined with platinum-based doublet chemotherapy, and whose final efficacy assessment after the last cycle shows disease control (SD, PR, or CR). Patients will be adaptively randomized into two groups based on the results of prior efficacy analysis. Subjects will be randomly assigned to Group A or Group B. Patients in Group A will receive an immune checkpoint inhibitor (ICI) plus 1-3 courses of allogeneic natural killer (NK) cell therapy. One course of NK cell therapy is designed to consist of two cycles, with a total of six NK cell infusions within 28 days, specifically on Days 12, 13, and 14 of the first cycle and Days 26, 27, and 28 of the second cycle. In addition, on Day 1 of each 21-day cycle, patients will receive standard-of-care treatment with intravenous infusion of an immune checkpoint inhibitor. Patients in Group B will receive standard-of-care treatment with intravenous infusion of an immune checkpoint inhibitor on Day 1 of each 21-day cycle, and treatment will continue until disease progression or unacceptable toxicity occurs. After signing the written informed consent form, patients will receive study treatment per protocol until disease progression or intolerable adverse events develop. The immune checkpoint inhibitors used in this study are those recommended for extensive-stage SCLC in the NCCN, ESMO, and CSCO guidelines, including but not limited to durvalumab, atezolizumab, serplulimab, and adebrelimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients receive immune checkpoint inhibitor plus 1-3 courses of allogeneic natural killer (NK) cell therapy. Each course consists of 6 NK cell infusions over 28 days, combined with standard ICI on Day 1 of each 21-day cycle.
| Arm | Type | Receives |
|---|---|---|
| ICI + Allogeneic NK Cells | Experimental | Biological: Allogeneic Natural Killer Cells, Drug: Immune Checkpoint Inhibitor |
| ICI Alone | Active comparator | Drug: Immune Checkpoint Inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1: Male or female, aged 18 years or above
- 2: ECOG score 0-2
- 3: metastatic or extensive-stage small cell lung cancer (SCLC) confirmed by histology or cytology, followed by 4 cycles of platinum-based doublet-chemotherapy with at least 2 cycles of immune checkpoint inhibitor plus chemotherapy. And stable disease (SD), partial response (PR), or complete response (CR) as assessed by imaging (RECIST1.1 criteria) after the last treatment. (The checkpoint inhibitors used were those recommended by the NCCN, ESMO, and CSCO guidelines for extensivestage SCLC, including but not limited to: Duvalumab, atezolizumab, slulizumab, adbelimumab, toripalimab, etc.)
- 4: After standard concurrent chemoradiotherapy, LS-SCLC could be enrolled in this study if sensitive relapse (relapse more than 6 months after the end of first-line treatment) progressed to extensive-stage (Ed) and met the inclusion criteria No.3;
- 5: At least 4 weeks after major surgery or trauma, and the wound must be completely healed; At least 1 week after minor surgical procedures or trauma (e.g., tissue biopsy or fine-needle aspiration);
Key exclusion criteria (11 listed)
- 1:Participate in other clinical trials or use other research drugs or equipment within 4 weeks of the first treatment.
- 2: During the screening period and previous imaging evaluation, active or untreated CNS metastasis was found by CT scanning or MRI. Patients with asymptomatic CNS metastasis who had been treated in the past can participate in this study as long as they meet all the following criteria: corticosteroids are not needed to treat CNS diseases, and imaging examination has not found any progress from the end of CNS directional treatment to the screening period。 If new asymptomatic CNS metastases are found in patients during the screening period, they must undergo radiotherapy and/or CNS metastasis surgery
- 3: The effusion in the third space with clinical symptoms needs repeated drainage (for example, less than once every four weeks), such as pericardial effusion, pleural effusion and peritoneal effusion that are still uncontrollable after pumping or other treatments
- 4: Live vaccine was inoculated within 30 days before the first administration of the study drug. Live vaccines include but are not limited to measles, mumps, minute needle, chickenpox/herpes zoster, rabies, BCG, typhoid vaccine, etc. Seasonal influenza vaccine for injection is generally inactivated virus vaccine, which is allowed to be used.
- 5: The patient is known to have other malignant tumors, which are progressing or need active treatment in the past 3 years (except for in situ cancer or localized prostate cancer supplemented by PSA test)
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 |
|---|---|---|
| Allogeneic Natural Killer CellsAllogeneic NK cells derived from healthy donors, expanded and activated ex vivo. One course consists of two cycles with 6 IV infusions over 28 days: Days 12, 13, 14 (Cycle 1) and Days 26, 27, 28 (Cycle 2). Patients receive 1-3 courses. | Biological | ICI + Allogeneic NK Cells |
| Immune Checkpoint InhibitorImmune checkpoint inhibitors recommended for extensive-stage SCLC by NCCN, ESMO, and CSCO guidelines, including but not limited to durvalumab, atezolizumab, serplulimab, adebrelimab, and toripalimab. Administered as IV infusion on Day 1 of each 21-day cycle. | Drug | ICI + Allogeneic NK Cells, ICI Alone |
Primary outcome
Progression free survival
Time frame: Every 6 weeks from randomization until disease progression or death, up to approximately 24 months
Duration of Overall Response
Time frame: From first documented response to disease progression, assessed every 6 weeks up to 24 months
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through 30 days after last dose, up to approximately 24 months
5 secondary outcomes
overall survival
Time frame: From randomization to death from any cause, assessed up to 24 months
Change from baseline in peripheral blood lymphocyte subsets (CD3+CD4+, CD3+CD8+, total CD3+, CD3-CD19+, and CD3-CD16+CD56+ cells) at Day 90
Time frame: Baseline and Day 90
Change from baseline in serum cytokine levels (IL-2, IL-4, IL-6, IL-10, TNF-β, and IFN-γ) at Day 90
Time frame: Baseline and Day 90
Change from baseline in serum tumor markers (SCC) at Day 90
Time frame: Baseline and Day 90
Change from baseline in peripheral blood NK cell activity at Day 90
Time frame: Baseline and Day 90
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. According to the research process, the research team chooses specific ways to disclose the original data.
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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 2 study testing Allogeneic Natural Killer Cells and Immune Checkpoint Inhibitor in people with Small Cell Lung Cancer, run by Tianjin First Central Hospital 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 12 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Gang Zhi Zhao (+8615302131398, xushan1012@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: Every 6 weeks from randomization until disease progression or death, up to approximately 24 months). The study lists 3 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 12 Aug 2026.