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 - GALAXIES LUNG-201

GlaxoSmithKline Research & Development Limited0 个研究点目标入组 300 人开始时间: 2022年8月10日最近更新: 2024年6月24日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: GlaxoSmithKline Research & Development Limited
入组人数: 300

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: All

入选标准

•Key Inclusion Criteria
•1. Is capable of giving signed informed consent
•2. Is, at the time of signing the ICF, at least 18 years old or the legal
•age of consent in the jurisdiction in which the study is taking place.
•3. 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). Mixed tumors will be categorized by the predominant cell type; if small cell or neuroendocrine elements are present, the participant is ineligible.
•4. Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
•NOTE: Completion of treatment with cytotoxic chemotherapy and/or
•radiation as part of neoadjuvant/adjuvant therapy is allowed if therapy was completed at least 6 months prior to the diagnosis of locally advanced or metastatic disease. Prior treatment with
•neoadjuvant/adjuvant immunotherapy is not permitted.
•5. Has a PD-L1-high tumor performed locally or confirmed via central
•6. Has measurable disease based on RECIST 1.1 (Appendix 7), as
•determined by the investigator.
•7. Has an ECOG PS 0 or 1.
•8. Has adequate organ function
•9. If of childbearing potential, female participants must be willing to use adequate contraception.
•Refer to the protocol for full list of inclusion criteria
•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 165
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 135

排除标准

•Key Exclusion criteria
•1. 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 other known 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.
•2. Has had major surgery within 4 weeks of the first dose of study
•intervention or has received lung radiation therapy of >30 Gy (for any
•purpose, including palliatively) within 6 months prior to the first dose of study intervention.
•3. 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.
•4. Has never smoked, defined as smoking <100 tobacco cigarettes in a
•lifetime. 5. Has an invasive malignancy or history of invasive malignancy other than disease under study within the last 5 years (clinical exceptions apply as per protocol).
•6. Has known symptomatic, untreated, or actively progressing brain
•metastases and/or leptomeningeal disease. Participants who have received prior therapy for brain metastases and have stable CNS disease may participate, provided they are neurologically stable for at least 2 weeks before randomization and have been off corticosteroids for at least 3 days prior to the date of randomization.
•7. Has autoimmune disease or syndrome (current or history thereof)
•that required systemic treatment within the past 2 years.
•8. Has received systemic steroid therapy =3 days prior to the first dose of study intervention or is receiving any other form of immunosuppressive medication. Replacement therapy is not considered a form of systemic therapy.
•9. Has received any live vaccine within 30 days prior to first dose of
•study intervention. NOTE: mRNA and adenoviral-based COVID-19
•vaccines are considered non-live. Study participants can be vaccinated against COVID-19 using vaccines authorized via the appropriate regulatory mechanisms (e.g., Emergency Use Authorization, Conditional Marketing Authorization, or Marketing Authorization Application). Refer to Section 6.8, Section 11.7.3, and the SRM for further information regarding COVID-19 vaccination recommendations and data to be collected in the eCRF.
•10. Has any history of idiopathic pulmonary fibrosis, organizing
•pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or
•evidence of active pneumonitis.
•11. Has symptomatic ascites or pleural effusion. A participant who is
•clinically stable following treatment of these conditions (including
•therapeutic thoracentesis or paracentesis) is eligible if the participant
•otherwise meets entry criteria.
•12. Has active inflammatory bowel disease, acute diverticulitis,
•intraabdominal abscess, gastrointestinal obstruction, or peritoneal
•carcinomatosis.
•13. Has a history or evidence of cardiac abnormalities within the
•6 months prior to enrollment.
•14. QTcF >470 msec, or >480 msec for participants with bundle branch block. QTcF is QT corrected for heart rate according to Fridericia's formula and can be machine calculated or manually over-read. 15. Has current unstable liver or biliary disease per investigator
•assessment defined by the presence of ascites, encephalopathy,
•coagulopathy, hypoalbuminemia, esophageal or gastric varices,
•persistent jaundice, or c

研究者

发起方

GlaxoSmithKline Research & Development Limited

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