EUCTR2021-005115-32-PT进行中（未招募）1 期
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-Positive Non Small Cell Lung Cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •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 protocol for other 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 within 6 months of 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 the disease under study within the last 5 years
- •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
- •7. Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
- •8. Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.
- •9. 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.
- •10. Has active inflammatory bowel disease, acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal carcinomatosis.
- •11. Has a history or evidence of cardiac abnormalities within the 3 months prior to enrollment
- •12. 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.
- •13. Has active tuberculosis (i.e., history of exposure or history of positive tuberculosis test, plus presence of clinical symptoms or physical or radiographic findings).
- •14. Has a known human immunodeficiency virus infection.
- •15. Has a history of severe hypersensitivity to mAbs or to any of the excipients in the formulations of the components of the study interventions.
- •16. Has a positive test for the presence of HBsAg at Screening or within 3 months prior to first dose of study intervention.
- •17. Has a positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of study intervention.
- •NOTE: Participants with a positive hepatitis C antibody test due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
- •18. Has a positive hepatitis C RNA test result at Screening or within 3 months prior to first dose of study intervention.
- •NOTE: Participants with a negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
- •Refer protocol for other exclusion criteria
研究者
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