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NOT YET RECRUITING
NCT07729670
PHASE2

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-06

Completion Date

2031-06

Last Updated

2026-07-27

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Multimodal Ablation

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

DRUG

Neoadjuvant therapy

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.

PROCEDURE

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.

DRUG

Adjunctive therapy

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.