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

NCT06939127 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CONCEPT study
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC (Non-small Cell Lung Cancer)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.

  Up to approximately 8 weeks following completion of neoadjuvant treatment

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  Up to Study Week 15 (before surgery)

• Radiological downstaging rate

  Up to Study Week 15 (before surgery)

• Major Pathological Response (mPR) Rate

  Up to approximately 8 weeks following completion of neoadjuvant treatment

• Event Free Survival (EFS)

  Up to approximately 2 years

• Overall Survival (OS)

  Up to approximately 2 years

Study Arms (1)

Cryoablation Combined with Tislelizumab

EXPERIMENTAL

Neoadjuvant Phase: Eligible 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. Surgery should be performed as soon as possible within 4-6 weeks after the last dose of neoadjuvant therapy. Adjuvant Phase: 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.

Drug: Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy; Procedure: Surgery; Drug: Adjuvant tislelizumab

Interventions

Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy DRUG

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)

Cryoablation Combined with Tislelizumab

Surgery PROCEDURE

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

Cryoablation Combined with Tislelizumab

Adjuvant tislelizumab DRUG

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.

Cryoablation Combined with Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, 300000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Drug Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Dongsheng Yue Chief Physician of Surgery

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donsheng Yue Chief Physician of Surgery

CONTACT

+8602223109106; yuedongsheng_cg@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Surgery

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 22, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)