A phase II study of durvalumab plus tremelimumab with chemotherapy for patients with relapse during or early after chemoradiotherapy followed by durvalumab for unresectable locally advanced NSCLC (TRITON)

未提供0 个研究点目标入组 33 人开始时间: 2024年6月17日最近更新: 2025年6月24日

适应症

试验速览

暂无简介。

•1.Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
•2.Negative or unknown activating driver oncogene mutation/ translocation.
•3.Patients must have received definitive concurrent chemoradiotherapy and durvalumab as consolidation therapy for NSCLC (locally advanced, unresectable, stage III or post operative, locally reccurent disease).
•4.Durvalumab has not been permanently discontinued due to adverse events (AEs), or durvalumab has been held due to AEs and subsequently reinitiated.
•5.Disease progression was observed at least 4 months after the date of completion of thoracic radiotherapy, and disease progression was observed during durvalumab therapy or within 6 months of the last dose of durvalumab.
•6.Age is at least 18 years.
•7.ECOG Performance status of 0 or
•8.Meet the following criteria for major organ function within 14 days prior to enrolment.
•a.Neutrophil count: >= 1,500 /mm3
•b.Hemoglobin: >= 9.0 g/dL
•c.Platelet count: >= 10.0 x 104 /mm3
•d.AST, ALT: <= 2.5 times the upper limit of the facility reference value
•e.Total bilirubin: <= 1.5 times the upper limit of the facility reference value
•f.Serum creatinine: < 1.5 mg/dL
•g.SpO2 >= 95 %(room air)

•1.Active interstitial lung disease, or radiation pneumonitis/ organizing pneumonia due to radiation therapy requiring corticosteroids.
•2.Previous immunotherapy has caused >=Grade 3 immune-related adverse events (irAEs) defined by CTCAE v5.0 (excluding endocrine disorders), or irAEs have not improved to the baseline condition prior to initiation of immunotherapy (excluding endocrine disorders).
•3.Clinically unstable or symptomatic brain metastasis, meningeal carcinomatosis or spinal cord compression.
•4.Active Hepatitis B or C, HIV infection, or active tuberculosis infection.
•5.Active autoimmune disease, history of immunodeficiency or serious complications.
•6.Another primary malignancy within 5 years.
•7.Patients who are judged inappropriate to participate in the study by the principal investigator or sub-investigators.

Objective response rate (ORR)

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发起方

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