A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer

Ishibashi Hideyasu0 个研究点目标入组 300 人开始时间: 2022年9月28日最近更新: 2023年10月17日

试验速览

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•Participant must be more than or equal to (>=)18 years of age.
•Has a histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or nonsquamous).
•Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
•Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC.
•Has a PD-L1-high (TC/TPS-50%) tumor as determined by the DAKO 22C3 or VENTANA SP263 assay performed by a local laboratory or by the VENTANA SP263 assay at a central laboratory.
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
•Adequate organ function per protocol specifications.
•Male or female participants.
•Female participants are eligible to participate if they are not breastfeeding or pregnant (or intend to breastfeed or become pregnant). Women of childbearing potential must use a highly effective method of contraception.

•-Has NSCLC with a tumor that harbors any of the following molecular alterations:
•a.EGFR mutations that are sensitive to available targeted inhibitor therapy
•b.ALK translocations that are sensitive to available targeted inhibitor therapy.
•c.Any otherknown genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.
•-Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30Gy within 6months of the first dose of study intervention.
•-Has received prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting PD-1, PD-L1, CTLA-4, TIGIT, CD96, or other checkpoint pathways.
•-Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime.
•-Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5years.
•-Has known symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease.
•-Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
•-Has symptomatic ascites or pleural effusion

发起方

Ishibashi Hideyasu