A Phase II Study of Nivolumab and Ipilimumab in Combination with Chemotherapy after Lung Stereotactic Body Radiotherapy as First-Line Therapy in Stage IV Non-Small Cell Lung Cancer. (NEJ053C)

未提供0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年3月28日

试验速览

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•(1) Diagnosed as non-small cell lung cancer by either histology or cytology.
•(2) Diagnosed as clinical stage IV (UICC-TNM classification, 8th edition) or postoperative recurrence.
•(3) No prior systemic chemotherapy for lung cancer.
•(4) No history of chemotherapy with immune checkpoint inhibitors for other cancer types.
•(5) For non-squamous NSCLC, EGFR gene mutation is negative.
•(6) Negative or unknown for ALK fusion gene, ROS1 fusion gene, BRAF (V600E) mutation, MET exon 14 skipping mutation, RET fusion gene, or NTRK fusion gene.
•(7) Age 20 years or older at the date of registration.
•(8) A baseline Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
•(9) PD-L1 (22C3) expression is not required.
•(10) Patients must have primary pulmonary lesion, mediastinal or hilar lymph node metastases, or any of them, amenable to radiotherapy.
•(11) Patients with measurable lesions.
•(12) No symptomatic brain metastases, meningeal carcinomatosis, or spinal metastases requiring radiotherapy or surgery.
•(13) No autoimmune disease and no history of chronic or recurrent autoimmune disease.
•(14) Patients are expected to survive for at least 12 weeks.
•(15) Patients obtain written informed consent.

•(1) Patients with concurrent multiple cancers or heterogeneous multiple cancers with a disease-free interval of 2 years or less
•(2) Patients with interstitial pneumonia, drug-induced interstitial lung disease, or clinically active interstitial lung disease on chest CT scan
•(3) Patients with a history of radiotherapy to the chest
•(4) Patients with symptoms such as dyspnea associated with SVC syndrome or airway stenosis who require palliative radiotherapy to the chest
•(5) Patients who are receiving oxygen
•(6) Patients with infections that require systemic treatment.
•(7) Patients who are receiving continuous systemic administration of steroids or other immunosuppressive drugs at a dose higher than 10 mg/day of prednisolone equivalent.
•(8) Patients with serious complications.

Progression-free survival rate at 6 months after enrollment

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