Phase Ib, multicenter, open label study of PDR001 in combination with platinum-doublet chemotherapy in PD-L1 unselected, metastatic NSCLC patients - CPDR001C2101

ovartis0 个研究点目标入组 6 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•* Female and male patients * 18 years.
•* Stage IIIB or stage IV NSCLC or relapsed locally advanced or metastatic NSCLC. See protocol page 42 for more details, incl. criteria for groups A-D.
•* Patient who received previous neo-adjuvant or adjuvant systemic therapy will be eligible for enrollment only if relapse has occurred more than 12 months from the end of this therapy.
•* Histologically or cytologically confirmed diagnosis of NSCLC that is EGFR Wild-type, ALK-negative gene changes and ROS1-negative gene changes. See protocol page 42-43 for details.
•* ECOG performance status 0-1.
•* At least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.

•* History of severe hypersensitivity reactions to other monoclonal antibodies which in the opinion of the investigator may pose an increased risk of a serious infusion reaction.
•* History of interstitial lung disease or interstitial pneumonitis. See protocol page 44 for details.
•* Major surgery in the last 4 weeks. See protocol page 44 for details.
•* Thoracic radiotherapy to lung fields in the last 4 weeks. More details on radiotherapy: see protocol page 44.
•* Clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months). See protocol page 44-45 for details.
•* Active, known or suspected autoimmune disease or a documented history of autoimmune disease. See protocol page 45 for details.
•* A condition requiring chronic systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within the last 7 days. See protocol page 45 for details.
•* Any live vaccines against infectious diseases within the last 4 weeks.
•* Pregnancy, lactation, insufficient contraception for females of childbearing potential and males.

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