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New treatment option for NSCLC (Non-small Cell Lung Cancer)
Official title Cryoablation Combined With Tislelizumab and Chemotherapy as Neoadjuvant and Adjuvant Therapy in Resectable Stage II-IIIB NSCLC
ClinicalTrials.gov ID: NCT06939127
What this study is testing
What is Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy?
Neoadjuvant Cryoablation Combined with Tislelizumab and Chemotherapy is an investigational medicine, being studied as a potential treatment for nsclc (non-small cell lung cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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...
- Locally advanced, unresectable disease, regardless of stage or metastasis (stage IV). Patients with mediastinal lymph node involvement on CT must...
- History of interstitial lung disease, non-infectious pneumonitis, or uncontrolled pulmonary fibrosis.
- Severe chronic or active infections requiring systemic antimicrobials, including tuberculosis.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.