RecruitingPhase 2NCT06939127

Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC

A Prospective Phase II Study to Explore the Efficacy and Safety of Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant Treatment, Followed by Adjuvant Tislelizumab Therapy in Resectable Stage II-IIIB Non-small Cell Lung Cancer

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

38 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

NSCLC (Non-small Cell Lung Cancer)

Summary

This is a Phase II single-arm study designed to evaluate the efficacy and safety of cryoablation combined with tislelizumab and platinum-based doublet chemotherapy as neoadjuvant therapy, followed by adjuvant tislelizumab therapy in patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). The study consists of a screening phase, a treatment phase (including the neoadjuvant stage, surgery, and adjuvant stage), a safety follow-up period, and a survival follow-up period.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment approach that combines cryoablation (using extreme cold to destroy a small tumor), an immunotherapy drug called tislelizumab, and chemotherapy before and after surgery for certain patients with early-stage non-small cell lung cancer (NSCLC). The goal is to see if this combination improves outcomes. **You may be eligible if...** - You are 18 or older - You have confirmed stage II–IIIB non-small cell lung cancer - Your tumor is 5 cm or smaller - A surgeon has determined your cancer can potentially be fully removed - You have adequate heart, lung, and organ function for surgery - You have not received any prior treatment for your current lung cancer **You may NOT be eligible if...** - You have received prior chemotherapy, radiation, or immunotherapy for this lung cancer - Your tumor has known EGFR mutations or ALK gene rearrangements (specific genetic changes that require different treatments) - Your cancer is locally advanced and cannot be removed regardless of stage, or has spread (stage IV) - You have a history of serious lung disease (interstitial lung disease, active pulmonary fibrosis) - You have an active autoimmune disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNeoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy

Eligible patients will start the study treatment (7-14 days between pathological diagnosis and cryoablation). Patients first undergo cryoablation of the primary tumor. Then, 7±3 days after cryoablation, they start treatment with tislelizumab (200 mg) plus platinum-based doublet chemotherapy, given every 3 weeks for 3-4 cycles. The following platinum-based doublet chemotherapy regimens are allowed in this trial: * Cisplatin/carboplatin + pemetrexed (non-squamous NSCLC) * Cisplatin/carboplatin + albumin-bound paclitaxel/paclitaxel (squamous NSCLC)

PROCEDURESurgery

After completing neoadjuvant therapy, surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy.

DRUGAdjuvant tislelizumab

Patients receiving adjuvant therapy must meet the following criteria: * ECOG performance status score of 0 or 1 * Recovery from surgery and adequate organ function as determined by the investigator based on laboratory values During the adjuvant phase, patients will receive tislelizumab as adjuvant therapy. The first dose of tislelizumab (cycle 1 of the adjuvant phase) should be administered within 2-8 weeks after surgery. Patients will continue to receive tislelizumab (400 mg, Q6W) as adjuvant therapy every 6 weeks until one of the following events occurs: completion of 8 cycles of tislelizumab adjuvant therapy, disease recurrence, unacceptable adverse events (AEs), death, or decision by the patient and/or investigator to discontinue study treatment.