NSCLCPhase 2NCT07729670
Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC
A Phase 2 study testing Multimodal Ablation, Neoadjuvant therapy and Surgery in people with NSCLC, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
This is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) 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
- NSCLC
- What is being tested?
- Multimodal Ablation, Neoadjuvant therapy and Surgery
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2031
- 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
- Age >= 18 years, either gender;
- Pathologically confirmed stage II-IIIB (N2) squamous or non-squamous non-small cell lung cancer (NSCLC) according to the 9th edition of the AJCC/UICC NSCLC staging system;
- Presence of lesions suitable for ablation therapy confirmed by imaging evaluation;
- Evaluated as resectable with R0 resection before enrollment, and consent to undergo radical surgical resection;
- ECOG performance status score of 0-1;
- Eligible for platinum-based doublet chemotherapy;
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- Adequate cardiopulmonary function to meet the requirements of curative surgical resection;
- Sufficient organ function confirmed by laboratory tests within 28 days before enrollment:
- Blood routine: WBC >= 3.0×10^9/L; ANC >= 1.5×10^9/L; PLT >= 100×10^9/L; HGB >= 90 g/L.
- Liver function: AST <= 5.0×ULN; ALT <= 5.0×ULN; TBIL <= 1.5×ULN;
- Renal function: Cr <= 1.5×ULN;
- For patients receiving cisplatin: creatinine clearance >= 60 mL/min.
- For patients receiving carboplatin: creatinine clearance >= 45 mL/min.
- Coagulation function: INR <= 1.5×ULN (<=3×ULN for patients on anticoagulants; anticoagulants must be discontinued for one week before ablation); APTT <= 1.5×ULN;
- Fully understand the study and voluntarily sign the informed consent form (ICF).
Who cannot join
- Tumor is adjacent to the hilum, invades major blood vessels, or has contraindications for surgery;
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary diseases including pulmonary fibrosis and acute lung disease;
- Previous allogeneic stem cell transplantation or organ transplantation;
- Previous radiotherapy or chemotherapy;
- Previous local treatment (e.g., radioactive seed implantation, ablation) for the target ablation lesion;
- Previous treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies;
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- Complicated with severe cardiac, pulmonary, hepatic, renal insufficiency, or coagulation disorders;
- Clinically significant cardio-cerebrovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, heart failure of NYHA class III or IV, ventricular arrhythmia ≥ grade 2, any history of cerebrovascular accident;
- Underwent any major surgical procedure requiring general anesthesia within 28 days before enrollment;
- Previous severe immune system diseases or active infection;
- Pregnant or lactating female;
- Complicated with other malignancies (un cured within 5 years);
- Confirmed positive EGFR or ALK driver genes by genetic testing;
- Any condition requiring systemic therapy with corticosteroids (>10 mg prednisone per day or equivalent) or other immunosuppressive drugs before enrollment;
- Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis;
- Known history of HIV infection;
- Untreated chronic hepatitis B patients, chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL, or active hepatitis C virus (HCV) patients; (Note: Inactive hepatitis B surface antigen carriers, treated and stable hepatitis B patients (HBV DNA < 500 IU/mL), and cured hepatitis C patients are eligible.);
- Received live vaccine within 28 days before enrollment;
- Simultaneously participating in another therapeutic clinical study;
- Other conditions considered unsuitable for participation in this study by the investigator.
About this study
This is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) non-small cell lung cancer (NSCLC).
Read the detailed description
Eligible patients will receive multimodal ablation, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy, and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery.The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, event-free survival (EFS), overall survival (OS), and safety.
- Conditions
- NSCLC
- Being tested
- Multimodal Ablation, Neoadjuvant therapy, Surgery, Adjunctive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal AblationDevice
CT-guided preoperative multimodal ablation performed with multimodal tumor therapy system.Target lung lesions are ablated within 2 weeks after subject enrollment.
Also called Tislelizumab
Neoadjuvant tislelizumab (200 mg, IV, Q3W) combined with chemotherapy will be administered within 2 weeks after ablation. For patients with squamous NSCLC, cisplatin or carboplatin combined with paclitaxel will be used; for patients with non-squamous NSCLC, cisplatin or carboplatin combined with pemetrexed will be used, for a total of 3-4 cycles of treatment.
SurgeryProcedure or surgery
Surgical resection will be performed within 4-6 weeks after the last neoadjuvant treatment. The pulmonary lesions (including the ablated lesions) will be radically resected via surgery.
Adjunctive therapyDrug
Also called Tislelizumab
Adjuvant therapy will be initiated within 2-8 weeks after surgery. Postoperative adjuvant therapy with tislelizumab (400 mg, Q6W) will be maintained for up to 1 year. Concomitant chemotherapy is allowed during this period based on guidelines/consensus or multidisciplinary team (MDT) discussion.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy | Experimental | Patients in this single arm will receive a multimodal ablation procedure, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy , and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery as per protocol. Receives: Device: Multimodal Ablation; Drug: Neoadjuvant therapy; Procedure: Surgery; Drug: Adjunctive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response Rate
Proportion of patients with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy.
Measured: Perioperative
Secondary outcomes (4)
Major Pathological Response Rate
Proportion of patients with ≤10% residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy. Assessed by pathologist within 2 weeks after surgical resection.
Measured: Perioperative
Event-Free Survival
Time from start of treatment to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, or death from any cause. Patients without an event are censored at the date of last imaging assessment.
Measured: Through study completion, up to 5 years
Overall Survival
Time from enrollment to death due to any cause. Patients alive at last follow-up are censored at the last follow-up date. Lost-to-follow-up patients are censored at the last confirmed survival date.
Measured: Through study completion, up to 5 years
Incidence and Severity of Adverse Events and Serious Adverse Events
Safety will be assessed by monitoring the incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) graded according to NCI-CTCAE v6.0.
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729670
- Sponsor's protocol ID
- NCP1-1111
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC
- ClinicalTrials.gov ID
- NCT07729670
- Acronym / sponsor ID
- NCP1-1111
- Conditions
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 27 Jul 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 is a prospective, open-label, single-center, single-arm phase II clinical trial evaluating the efficacy and safety of multimodal ablation in combination with perioperative tislelizumab and chemotherapy in patients with pathologically confirmed resectable stage II-IIIB (N2) non-small cell lung cancer (NSCLC).
Detailed description
Eligible patients will receive multimodal ablation, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy, and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery.The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, event-free survival (EFS), overall survival (OS), and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy | Experimental | Device: Multimodal Ablation, Drug: Neoadjuvant therapy, Procedure: Surgery, Drug: Adjunctive therapyPatients in this single arm will receive a multimodal ablation procedure, followed by perioperative tislelizumab in combination with platinum-based doublet chemotherapy , and subsequently undergo radical surgical resection. Adjuvant tislelizumab will be continued after surgery as per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age >= 18 years, either gender;
- Pathologically confirmed stage II-IIIB (N2) squamous or non-squamous non-small cell lung cancer (NSCLC) according to the 9th edition of the AJCC/UICC NSCLC staging system;
- Presence of lesions suitable for ablation therapy confirmed by imaging evaluation;
- Evaluated as resectable with R0 resection before enrollment, and consent to undergo radical surgical resection;
- ECOG performance status score of 0-1;
Key exclusion criteria (20 listed)
- Tumor is adjacent to the hilum, invades major blood vessels, or has contraindications for surgery;
- History of interstitial lung disease, non-infectious pneumonia, or uncontrolled pulmonary diseases including pulmonary fibrosis and acute lung disease;
- Previous allogeneic stem cell transplantation or organ transplantation;
- Previous radiotherapy or chemotherapy;
- Previous local treatment (e.g., radioactive seed implantation, ablation) for the target ablation lesion;
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 |
|---|---|---|
| Multimodal AblationCT-guided preoperative multimodal ablation performed with multimodal tumor therapy system.Target lung lesions are ablated within 2 weeks after subject enrollment. | Device | Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy |
| Neoadjuvant therapyAlso: TislelizumabNeoadjuvant tislelizumab (200 mg, IV, Q3W) combined with chemotherapy will be administered within 2 weeks after ablation. For patients with squamous NSCLC, cisplatin or carboplatin combined with paclitaxel will be used; for patients with non-squamous NSCLC, cisplatin or carboplatin combined with pemetrexed will be used, for a total of 3-4 cycles of treatment. | Drug | Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy |
| SurgerySurgical resection will be performed within 4-6 weeks after the last neoadjuvant treatment. The pulmonary lesions (including the ablated lesions) will be radically resected via surgery. | Procedure or surgery | Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy |
| Adjunctive therapyAlso: TislelizumabAdjuvant therapy will be initiated within 2-8 weeks after surgery. Postoperative adjuvant therapy with tislelizumab (400 mg, Q6W) will be maintained for up to 1 year. Concomitant chemotherapy is allowed during this period based on guidelines/consensus or multidisciplinary team (MDT) discussion. | Drug | Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy |
Primary outcome
Pathological Complete Response Rate
Time frame: Perioperative
Proportion of patients with no residual viable tumor cells in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant therapy.
4 secondary outcomes
Major Pathological Response Rate
Time frame: Perioperative
Event-Free Survival
Time frame: Through study completion, up to 5 years
Overall Survival
Time frame: Through study completion, up to 5 years
Incidence and Severity of Adverse Events and Serious Adverse Events
Time frame: Through study completion
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 27 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multimodal Ablation, Neoadjuvant therapy and Surgery in people with NSCLC, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 15 inclusion and 20 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response Rate (time frame: Perioperative). 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 27 Jul 2026.