Clinical trial NCT06939127: Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NSCLC (Non-small Cell Lung Cancer)
Keywords: II-III NSCLC
neoadjuvant
adjuvant
pathological complete response
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Pathological Complete Response (pCR) Rate
timeFrame: Up to approximately 8 weeks following completion of neoadjuvant treatment
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Up to Study Week 15 (before surgery)
measure: Radiological downstaging rate
timeFrame: Up to Study Week 15 (before surgery)
measure: Major Pathological Response (mPR) Rate
timeFrame: Up to approximately 8 weeks following completion of neoadjuvant treatment
measure: Event Free Survival (EFS)
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: Number of participants experiencing treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 2 years
measure: Change From Baseline in Neoadjuvant and Adjuvant Phase in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: Baseline, during the neoadjuvant phase (Cycle 3), during the adjuvant phase (Cycles 1, 3, 5, and 7), and during safety follow-up visits (up to 2 years)
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Dongsheng Yue Chief Physician of Surgery
role: PRINCIPAL_INVESTIGATOR
References: