Multimodal Ablation Combined With Perioperative Tislelizumab and Chemotherapy for Resectable II-IIIB NSCLC

NCT07729670 | Not Yet Recruiting Phase 2

• 1 other identifier: NCP1-1111
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperative

Secondary Outcomes (4)

• Major Pathological Response Rate

  Perioperative

• Event-Free Survival

  Through study completion, up to 5 years

• Overall Survival

  Through study completion, up to 5 years

• Incidence and Severity of Adverse Events and Serious Adverse Events

  Through study completion

Study Arms (1)

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.

Device: Multimodal Ablation; Drug: Neoadjuvant therapy; Procedure: Surgery; Drug: Adjunctive therapy

Interventions

Multimodal Ablation DEVICE

CT-guided preoperative multimodal ablation performed with multimodal tumor therapy system.Target lung lesions are ablated within 2 weeks after subject enrollment.

Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy

Neoadjuvant therapy DRUG

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.

Also known as: Tislelizumab

Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy

Surgery PROCEDURE

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.

Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy

Adjunctive therapy DRUG

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.

Also known as: Tislelizumab

Multimodal Ablation Combined with Perioperative Tislelizumab and Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

MeSH Terms

Interventions

Neoadjuvant Therapy; tislelizumab; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: July 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2031
• Last Updated: July 27, 2026

Record last verified: 2026-06