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OncoMatch/Clinical Trials/NCT06127303

Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC

Is NCT06127303 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Toripalimab for non-small cell lung cancer.

Phase 2RecruitingShanghai Chest HospitalNCT06127303Data as of May 2026

Treatment: ToripalimabImmunotherapy with programmed death-1(PD-1) inhibitors is now standard therapy for first-line use in patients with driver-negative advanced NSCLC, whether as single-agent or in combination with chemotherapy. After progression of first-line immunotherapy, NSCLC patients may be treated with chemotherapy, radiotherapy or targeted therapies, among others. Recently, Immune Checkpoint inhibitors (ICIs) rechallenge has become a highly anticipated option. Although the objective response rate of the ICIs rechallenge patients has decreased substantially compared with the efficacy of the first ICI treatment, nearly 50% of patients can regain disease control. Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate viable tumour cells in target tissues. It has been reported that ablation can enhance immune response. The objective of this study was to evaluate the efficacy and safety of toripalimab (PD-1) in combination with cryoablation in the treatment of oligometastatic driver-negative advanced NSCLC after first-line immunotherapy progress.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard first-line therapy — advanced/metastatic

develop oligoprogression after receiving standard first-line therapy

Cannot have received: targeted therapy (osimertinib, erlotinib, crizotinib)

Previously received targeted therapy for advanced NSCLC (including osimertinib, erlotinib, crizotinib, etc)

Lab requirements

Blood counts

adequate hematologic function

Kidney function

adequate renal function

Liver function

adequate liver function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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