OncoMatch/Clinical Trials/NCT07855965
Multicenter, Single-Arm, Prospective Phase II Study of Neoadjuvant Cryo-Thermal Ablation Combined With Toripalimab and Chemotherapy for Resectable Stage IB-IIIB Non-Small Cell Lung Cancer
Official title: Efficacy and Safety of Cryo-Thermal Ablation Combined With Toripalimab and Chemotherapy as Neoadjuvant Treatment for Resectable Stage IB-IIIB Non-Small Cell Lung Cancer: A Multicenter, Single-Arm, Prospective Phase II Clinical Trial
Is NCT07855965 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Platinum-based doublet chemotherapy for carcinoma, non-small-cell lung (nsclc).
Treatment: Toripalimab · Platinum-based doublet chemotherapy — Neoadjuvant chemoimmunotherapy has improved outcomes in patients with resectable non-small cell lung cancer (NSCLC), but a substantial proportion of patients do not achieve a major pathological response. Cryo-Thermal Ablation may induce immunogenic tumor cell death and remodel the tumor immune microenvironment, potentially enhancing the antitumor activity of subsequent chemoimmunotherapy. This multicenter, single-arm, open-label, prospective Phase II study will evaluate the efficacy and safety of CT-guided Cryo-Thermal Ablation followed by toripalimab plus platinum-based doublet chemotherapy as neoadjuvant treatment for patients with resectable stage IB-IIIB NSCLC. For stage IB disease, only patients with cT2aN0M0 disease and a maximum primary tumor diameter of 4.0 cm are eligible. Patients with more advanced disease must be considered resectable by multidisciplinary team assessment according to the study protocol. Approximately 40 participants will receive Cryo-Thermal Ablation followed by 3 planned cycles of toripalimab plus platinum-based doublet chemotherapy and subsequent curative-intent surgical resection. The primary outcome is the pathological complete response (pCR) rate. Secondary outcomes include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), treatment-emergent adverse events (TEAEs), and health-related quality of life. Exploratory translational analyses will investigate treatment-associated local and systemic antitumor immune responses and molecular dynamics using spatial transcriptomics, T-cell receptor sequencing, tumor genomic profiling, circulating tumor DNA analysis, imaging mass cytometry, and exploratory intratumoral metagenomic and metabolomic profiling.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: EGFR sensitizing mutation
Presence of protocol-defined actionable oncogenic alterations detected by tumor tissue and/or plasma-based molecular testing, including: EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion
Excluded: EGFR exon 19 deletion
EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion
Excluded: EGFR l858r
EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion
Excluded: EGFR g719x
EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion
Excluded: EGFR s768i
EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion
Excluded: EGFR l861q
EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion
Excluded: EGFR exon 20 insertion
EGFR sensitizing or protocol-defined activating alterations, including exon 19 deletion, L858R, G719X, S768I, L861Q, or exon 20 insertion
Excluded: ALK rearrangement
ALK rearrangement
Excluded: ROS1 rearrangement
ROS1 rearrangement
Excluded: MET exon 14 skipping alteration
MET exon 14 skipping alteration
Excluded: MET amplification
protocol-defined MET amplification
Excluded: KRAS g12c
KRAS G12C
Excluded: BRAF v600e
BRAF V600E
Excluded: NTRK1 fusion
NTRK1/2/3 fusion
Excluded: NTRK2 fusion
NTRK1/2/3 fusion
Excluded: NTRK3 fusion
NTRK1/2/3 fusion
Excluded: RET rearrangement
RET rearrangement
Excluded: HER2 (ERBB2) alteration
HER2 alteration as defined in the study protocol
Disease stage
Required: Stage IB, IIA, IIB, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; absolute neutrophil count ≥1.0 × 10⁹/L; platelet count ≥90 × 10⁹/L
Kidney function
serum creatinine ≤2.0 mg/dL and creatinine clearance ≥60 mL/min
Liver function
total bilirubin ≤2.0 × ULN; ALT, AST, and ALP ≤2.5 × ULN
Cardiac function
no clinically significant abnormality in cardiac enzyme testing
Laboratory assessments performed within 7 days before the first study intervention must meet the following criteria: Hemoglobin ≥9.0 g/dL; absolute neutrophil count ≥1.0 × 10⁹/L; platelet count ≥90 × 10⁹/L; total bilirubin ≤2.0 × ULN; ALT, AST, and ALP ≤2.5 × ULN; serum creatinine ≤2.0 mg/dL and creatinine clearance ≥60 mL/min; adequate thyroid function. If TSH is outside the normal range, free T3 and free T4 must be within clinically acceptable limits; no clinically significant abnormality in cardiac enzyme testing; INR ≤1.5 and APTT ≤1.5 × ULN, unless abnormalities are attributable to protocol-permitted anticoagulation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07855965 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR sensitizing mutation is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR exon 19 deletion is an exclusion criterion.
What disease stage is eligible?
Stage IB or IIA or IIB or IIIA or IIIB is required.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages