OncoMatch

OncoMatch/Clinical Trials/NCT05477264

Concurrent Tislelizumab and Radiotherapy in Newly Diagnosed Extranodal NK/T-cell Lymphoma, Nasal Type

Is NCT05477264 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tislelizumab for lymphoma.

Phase 2RecruitingWon Seog KimNCT05477264Data as of May 2026

Treatment: TislelizumabThis clinical trial intends to analyze the efficacy of PD-1 inhibitor combined with radiotherapy for newly diagnosed NK/T-cell lymphoma. The investigational product in this clinical trial is tislelizumab, a PD-1 inhibitor. As a rationale for using PD-1 inhibitors in patients with NK/T-cell lymphoma, their efficacy has been proved several times mostly in patients with relapsed NK/T-cell lymphoma. Patients with low-stage NK/T-cell lymphoma usually receive high-concentration cytotoxic chemotherapy combined with radiotherapy, with treatment response rates of approximately 60 to 80%, but 80-90% of them experience hematological and non-hematologic toxicities during treatment. Therefore, this study intends to determine the efficacy and safety of PD-1 inhibitor(Tislelizumab) combined with radiotherapy as a first-line therapy compared with pre-existing cytotoxic chemotherapy combined with radiotherapy in patients with NK/T-cell lymphoma with low stage and International Prognostic Index.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Disease stage

Required: Stage IE, IIE

Excluded: Stage III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: chemotherapy

No history of prior treatment

Cannot have received: radiotherapy

No history of prior treatment

Cannot have received: targeted therapy

No history of prior treatment

Lab requirements

Blood counts

Absolute neutrophil > 1,500/mm3; Hemoglobin > 9.0g/dL; Platelet > 75,000/mm3

Kidney function

Serum creatinine ≤ 2.0mg/dL

Liver function

Total bilirubin, AST/ALT < 3xULN

Cardiac function

LVEF < 50% as measured by echocardiography, QTc > 480msec (QTcF) on ECG at screening, unstable angina, ventricular arrhythmias except for benign PVC, medically uncontrolled supraventricular and nodal arrhythmias, conduction abnormality requiring a pacemaker, valve disease with documented cardiac dysfunction

Adequate bone marrow function, as defined by the following laboratory values... Adequate organ function, as defined by the following laboratory values... Cardiovascular exclusion criteria listed.

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

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