Early Lung CancerPhase 2NCT07064876
Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer
A Phase 2 study testing Serplulimab and CT-guided Cryoablation in people with Early Lung Cancer, run by Xi Junjie at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if serplulimab combined with cryoablation can effectively treat early-stage non-small cell lung cancer (NSCLC) in adults who are not eligible for or decline surgery or radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Lung Cancer
- What is being tested?
- Serplulimab and CT-guided Cryoablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Oct 2025to Sep 2027
- 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
- Participants must meet all of the following criteria to be eligible for the study:
- Voluntarily agree to participate in this clinical study. Male or female patients aged ≥18 years at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed diagnosis of T1N0M0 non-small cell lung cancer (NSCLC) during the cryoablation procedure, classified as stage Ia (tumor size >1 cm and ≤3 cm) according to the 9th edition of the AJCC TNM staging system; patients with ground-glass nodules (GGNs) are excluded.
- No detectable driver mutations in EGFR, ALK, or ROS1 genes. Deemed ineligible for or unwilling to undergo surgery or radiotherapy after multidisciplinary team (MDT) discussion.
- At least one measurable target lesion within 4 weeks before the first dose, evaluated by the investigator according to mRECIST (2019) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 2. Life expectancy of ≥12 weeks.
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- Adequate organ function based on laboratory assessments within 14 days before first dose of study treatment, without prior transfusion, albumin, thrombopoietin, or colony-stimulating factor (CSF) support:
- Hematologic Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count ≥ 75 × 10⁹/L Hemoglobin ≥ 90 g/L Liver function Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) ALT ≤ 5 × ULN AST ≤ 5 × ULN Albumin ≥ 30 g/L Renal function Serum creatinine ≤ 1.5 × ULN; if >1.5 × ULN, creatinine clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula) Coagulation APTT ≤ 1.5 × ULN PT ≤ 1.5 × ULN INR ≤ 1.5 × ULN Urinalysis Urine protein dipstick ≤ 1+; if ≥ 2+, 24-hour urine protein < 1 g is acceptable Female participants must have a negative serum pregnancy test within 14 days prior to study treatment and agree to use effective contraception during the study and for at least 6 months after the last dose. Breastfeeding is not permitted during the study.
- Male participants must agree to use effective contraception or abstain from heterosexual intercourse during the study and for at least 6 months after the last dose. If the male participant has a female partner of childbearing potential or a pregnant partner, he must use condoms to avoid drug exposure to the embryo. Periodic abstinence and withdrawal are not acceptable contraception methods.
Who cannot join
- Known history of severe hypersensitivity to any monoclonal antibody (Grade >3, per NCI-CTCAE v5.0).
- Prior treatment with any immune checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- Known contraindications to cryoablation. Active infection requiring systemic antimicrobial therapy within 14 days prior to the first dose.
- History of myocardial infarction within 6 months before first dose, uncontrolled arrhythmias (including QTc ≥450 ms for males or ≥470 ms for females, calculated by Fridericia formula), NYHA Class III or IV heart failure, left ventricular ejection fraction <50%, or clinically significant pleural, pericardial, or peritoneal effusion requiring intervention.
- Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, or total serum calcium >12 mg/dL, or corrected calcium >ULN).
- History or presence of interstitial lung disease, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or other significant pulmonary conditions that may interfere with evaluation or management of potential treatment-related lung toxicity, as judged by the investigator.
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- Positive for HBsAg and detectable HBV DNA (active hepatitis B); or positive for HCV antibody and detectable HCV RNA (active hepatitis C); or positive syphilis serology (except non-active infections with specific antibody positive and non-specific antibody negative); or known HIV infection.
- Active or suspected autoimmune disease. Patients with stable autoimmune disease not requiring systemic immunosuppressive treatment are allowed.
- Active malignancy within 5 years, except for curatively treated localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, prostate, or breast with ≥5 years disease-free interval.
- Receipt of live or attenuated vaccines within 28 days before the first dose or planned during the study. Inactivated seasonal influenza vaccines are allowed.
- Receipt of radical radiotherapy within 3 months before the first dose. Presence of spinal cord compression not controlled by surgery and/or radiotherapy.
- History of deep vein thrombosis (DVT), ongoing anticoagulant or antiplatelet therapy, or history of severe bleeding or DVT associated with anti-angiogenic therapy.
- Poorly controlled hypertension, defined as blood pressure ≥160/100 mmHg despite optimal medical therapy.
- Underwent major surgery within 28 days prior to the first dose (major surgery is defined as a procedure requiring at least 3 weeks of recovery before study treatment).
- Participation in another interventional clinical trial within 3 months or 5 half-lives (whichever is longer) before screening.
- Planned or prior organ or bone marrow transplantation. Known history of psychiatric or substance abuse disorders that may interfere with study compliance or assessments.
- Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in 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
Zhongshan Hospital Affiliated to Fudan University, No. 180 Fenglin Road, Xuhui District,
Shanghai, Shanghai Municipality, 200032
Junjie Xi, Dr., +86-021-64041990, xjin15@fudan.edu.cn
About this study
Official title: A Single-Arm, Phase II Clinical Study of Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer
The goal of this clinical trial is to learn if serplulimab combined with cryoablation can effectively treat early-stage non-small cell lung cancer (NSCLC) in adults who are not eligible for or decline surgery or radiotherapy. The main questions it aims to answer are:
What is the objective response rate (ORR) after combination treatment with serplulimab and cryoablation? What are the progression-free survival (PFS), overall survival (OS), 1-year OS rate, and safety outcomes? This is a single-arm, phase II study with no comparison group.
Read more
Participants will:
Receive cryoablation under CT guidance to locally ablate the tumor Receive intravenous serplulimab (300 mg every 3 weeks) for up to 6 cycles Undergo regular imaging and laboratory tests to assess response and monitor safety Provide blood and tissue samples for optional biomarker research The study will enroll 25 patients with stage Ia NSCLC (tumor size >1 cm and ≤3 cm, no ground-glass opacity, EGFR/ALK/ROS1 wild-type) and aims to explore the potential of combining local and systemic immunotherapy in non-surgical candidates.
- Conditions
- Early Lung Cancer
- Being tested
- Serplulimab, CT-guided Cryoablation
- Keywords
- Cryoablation, early lung cancer, immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
PD-1 inhibitor, 300 mg intravenous infusion, once every 3 weeks (Q3W) for up to 6 cycles, starting after cryoablation recovery and in the absence of major procedural complications.
CT-guided CryoablationProcedure or surgery
Percutaneous cryoablation performed under CT guidance to achieve local tumor ablation. Procedure done once (per-protocol) prior to systemic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab + Cryoablation | Experimental | Participants in this arm will receive serplulimab combined with CT-guided cryoablation for the treatment of early-stage, inoperable non-small cell lung cancer (NSCLC). Cryoablation will be performed first to locally ablate the tumor. Following recovery, participants will receive intravenous serplulimab at a dose of 300 mg every 3 weeks for up to 6 cycles, starting as soon as no major post-procedural complications are observed. The combination therapy aims to evaluate efficacy (objective response rate) and safety, as well as explore potential biomarkers predictive of treatment outcomes. Receives: Drug: Serplulimab; Procedure: CT-guided Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients who achieve either a complete response (CR) or partial response (PR) as assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (mRECIST, 2019). Radiological evaluations will be conducted at regular intervals to determine tumor response. The evaluation will be based on measurable target lesions at baseline and follow-up imaging.
Measured: Up to 12 months
Secondary outcomes (2)
Progression-Free Survival (PFS)
PFS is defined as the time from the date of enrollment to the date of disease progression or death from any cause, whichever occurs first. Patients without progression or death will be censored at the last date of tumor assessment.
Measured: Up to 12 months
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of death from any cause. Patients alive at the time of analysis will be censored at the date of last follow-up.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi Junjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xi Junjie, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064876
- Sponsor's protocol ID
- KY2025098
- Status last verified
- Sep 2025
- First submitted
- 7 Jul 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Phase II Clinical Study of Serplulimab Combined With Cryoablation for Early-Stage Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07064876
- Acronym / sponsor ID
- KY2025098
- Conditions
- Early Lung Cancer
- Keywords
- Cryoablation, early lung cancer, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Xi JunjieUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 15 Jul 2025 (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.
The goal of this clinical trial is to learn if serplulimab combined with cryoablation can effectively treat early-stage non-small cell lung cancer (NSCLC) in adults who are not eligible for or decline surgery or radiotherapy. The main questions it aims to answer are:
What is the objective response rate (ORR) after combination treatment with serplulimab and cryoablation? What are the progression-free survival (PFS), overall survival (OS), 1-year OS rate, and safety outcomes? This is a single-arm, phase II study with no comparison group.
Participants will:
Receive cryoablation under CT guidance to locally ablate the tumor Receive intravenous serplulimab (300 mg every 3 weeks) for up to 6 cycles Undergo regular imaging and laboratory tests to assess response and monitor safety Provide blood and tissue samples for optional biomarker research The study will enroll 25 patients with stage Ia NSCLC (tumor size >1 cm and ≤3 cm, no ground-glass opacity, EGFR/ALK/ROS1 wild-type) and aims to explore the potential of combining local and systemic immunotherapy in non-surgical candidates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab + Cryoablation | Experimental | Drug: Serplulimab, Procedure: CT-guided CryoablationParticipants in this arm will receive serplulimab combined with CT-guided cryoablation for the treatment of early-stage, inoperable non-small cell lung cancer (NSCLC). Cryoablation will be performed first to locally ablate the tumor. Following recovery, participants will receive intravenous serplulimab at a dose of 300 mg every 3 weeks for up to 6 cycles, starting as soon as no major post-procedural complications are observed. The combination therapy aims to evaluate efficacy (objective response rate) and safety, as well as explore potential biomarkers predictive of treatment outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must meet all of the following criteria to be eligible for the study:
- Voluntarily agree to participate in this clinical study. Male or female patients aged ≥18 years at the time of signing the informed consent form (ICF).
- Histologically or cytologically confirmed diagnosis of T1N0M0 non-small cell lung cancer (NSCLC) during the cryoablation procedure, classified as stage Ia (tumor size >1 cm and ≤3 cm) according to the 9th edition of the AJCC TNM staging system; patients with ground-glass nodules (GGNs) are excluded.
- No detectable driver mutations in EGFR, ALK, or ROS1 genes. Deemed ineligible for or unwilling to undergo surgery or radiotherapy after multidisciplinary team (MDT) discussion.
- At least one measurable target lesion within 4 weeks before the first dose, evaluated by the investigator according to mRECIST (2019) criteria.
Key exclusion criteria (17 listed)
- Known history of severe hypersensitivity to any monoclonal antibody (Grade >3, per NCI-CTCAE v5.0).
- Prior treatment with any immune checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
- Known contraindications to cryoablation. Active infection requiring systemic antimicrobial therapy within 14 days prior to the first dose.
- History of myocardial infarction within 6 months before first dose, uncontrolled arrhythmias (including QTc ≥450 ms for males or ≥470 ms for females, calculated by Fridericia formula), NYHA Class III or IV heart failure, left ventricular ejection fraction <50%, or clinically significant pleural, pericardial, or peritoneal effusion requiring intervention.
- Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, or total serum calcium >12 mg/dL, or corrected calcium >ULN).
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 |
|---|---|---|
| SerplulimabPD-1 inhibitor, 300 mg intravenous infusion, once every 3 weeks (Q3W) for up to 6 cycles, starting after cryoablation recovery and in the absence of major procedural complications. | Drug | Serplulimab + Cryoablation |
| CT-guided CryoablationPercutaneous cryoablation performed under CT guidance to achieve local tumor ablation. Procedure done once (per-protocol) prior to systemic therapy. | Procedure or surgery | Serplulimab + Cryoablation |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 12 months
ORR is defined as the proportion of patients who achieve either a complete response (CR) or partial response (PR) as assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (mRECIST, 2019). Radiological evaluations will be conducted at regular intervals to determine tumor response. The evaluation will be based on measurable target lesions at baseline and follow-up imaging.
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 12 months
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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 Serplulimab and CT-guided Cryoablation in people with Early Lung Cancer, run by Xi Junjie 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 9 inclusion and 17 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 15 Sep 2025. 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 Junjie Xi, Dr (+86-021-64041990, xjin15@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 12 months). 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 15 Sep 2025.