A Phase 2 Randomized Double-blind Study of BMS-986207 in Combination with Nivolumab and Ipilimumab as First-line Treatment for Participants with Stage IV Non-Small Cell Lung Cancer

Bristol-Myers Squibb International Corporation0 个研究点目标入组 240 人开始时间: 2021年10月1日最近更新: 2022年2月1日

适应症

试验速览

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•Males and females; = 18 years of age or local age of majority.
•Histologically confirmed metastatic 1L Stage IV NSCLC of squamous or nonsquamous histology
•No prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic NSCLC
•Measureable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
•Eastern Cooperative Oncology Group (ECOG) performance status 0-1
•Participants must have a life expectancy of at least 3 months at the time of first dose.
•A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor tissue obtained during screening or prior to enrollment (within 3 months of enrollment and with no intervening systemic anticancer treatment between time of acquisition and enrollment). Samples must be sent to central laboratory and confirmed to be evaluable prior to treatment assignment or randomization.
•Assessment of tumor-cell PD-L1 expression by immunohistochemistry must be performed by central laboratory using pre-treatment tissue sample, and results must be reported prior to randomization (Part 2).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutations which are sensitive to available targeted inhibitor therapy. Participants with nonsquamous histology and unknown EGFR, ALK, or ROS-1 status are also excluded.
•Participants with known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF) V600E mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown or indeterminate BRAF mutation status are eligible.
•Participants with untreated central nervous system metastases.
•Participants with leptomeningeal metastases (carcinomatous meningitis).
•Concurrent malignancy requiring treatment.
•Participants with an active, known, or suspected autoimmune disease.
•Prior treatment with anti-TIGIT, anti-PD-(L)1, anti- CTLA-4 antibody or any other antibody
•or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
•Women who are pregnant or breastfeeding

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