Cryoablation with Tislelizumab and Chemotherapy for Non-small Cell Lung Cancer

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

This study is testing if combining a freezing treatment with a new drug and chemotherapy can help people with early-stage lung cancer before surgery and improve their chances of survival.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, tislelizumab
• Locations: 1 site (Tianjin)
• Trial ID: NCT06939127 on ClinicalTrials.gov

What this trial studies

This Phase II study evaluates the safety and efficacy of combining cryoablation with tislelizumab and platinum-based chemotherapy as neoadjuvant therapy for patients with resectable stage II-IIIB non-small cell lung cancer (NSCLC). Participants will undergo a screening phase followed by a treatment phase that includes neoadjuvant therapy, surgery, and adjuvant therapy with tislelizumab. The study aims to assess the pathological complete response and overall survival outcomes. Safety and survival follow-up periods will also be included to monitor long-term effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage II-IIIB NSCLC suitable for radical surgical resection.

Not a fit: Patients with prior lung cancer treatments, locally advanced unresectable disease, or specific genetic mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with resectable stage II-IIIB NSCLC.

How similar studies have performed: While similar approaches have been explored, this specific combination of cryoablation, tislelizumab, and chemotherapy in this patient population is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Aged ≥18 years at informed consent signing.
* ECOG performance status of 0 or 1.
* Histologically confirmed stage II-IIIB NSCLC (AJCC 9th edition).
* Tumor size ≤5 cm.
* Deemed suitable for R0 resection by a thoracic surgeon for radical treatment.
* Adequate cardiopulmonary function for radical surgical resection.
* Eligible for cryoablation and platinum-based doublet chemotherapy.
* Adequate blood and organ function, as per laboratory tests within 14 days before enrollment.

Exclusion Criteria:

* Prior treatment for current lung cancer, including chemotherapy or radiotherapy.
* LCNEC diagnosis.
* Known EGFR mutations or ALK translocations. For non-squamous NSCLC, EGFR mutation status must be confirmed locally or centrally if unknown.

For squamous NSCLC, EGFR testing is not required if status is unknown. ALK translocation testing is not required if status is unknown.

* Locally advanced, unresectable disease, regardless of stage or metastasis (stage IV). Patients with mediastinal lymph node involvement on CT must undergo sampling for clinical staging to exclude stage IIIB/C.
* History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis.
* Severe chronic or active infections requiring systemic antimicrobials, including tuberculosis.
* Hospitalization for severe infections within 4 weeks before enrollment. Systemic antibiotic treatment within 2 weeks before enrollment.
* Active autoimmune disease or history of recurrent autoimmune disease.
* Exceptions: Well-controlled type 1 diabetes, hypothyroidism on hormone replacement, celiac disease, skin conditions not requiring systemic therapy, or diseases unlikely to recur without provocation.
* Severe infections requiring systemic treatment within the past 4 weeks.
* Corticosteroid or immunosuppressive use within 14 days before enrollment, except for specific local, topical, or short-term uses.

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)

Study contacts

• Principal investigator: Dongsheng Yue Chief Physician of Surgery — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Donsheng Yue Chief Physician of Surgery

Conditions NSCLC; II-III NSCLC; neoadjuvant; adjuvant; pathological complete response