2024-518839-11-00招募中2 期
KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants with Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 18
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
- To evaluate the OR per RECIST 1.1 as assessed by BICR
- To evaluate the safety and tolerability of investigational treatments when used as monotherapy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
- •Documented disease progression as assessed by investigator using RECIST 1.1 after receiving both anti-programmed cell death ligand 1 (anti-PD-[L]1) treatment and platinum-based chemotherapy per local standard of care
- •Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- •Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
- •Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
排除标准
- •Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- •History of (noninfectious) pneumonitis/Interstitial Lung Disease (ILD) that required steroids or has current pneumonitis/ILD, and/or suspected ILD/pneumonitis
- •Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
- •Active infection requiring systemic therapy
- •Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
- •Concurrent active Hepatitis B (defined as Hepatitis B surface antigen (HBsAg) positive and/or detectable Hepatitis B virus (HBV) deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
- •Active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)
- •Known history of, or active, neurologic paraneoplastic syndrome
- •History of allogeneic tissue/solid organ transplant
- •Has not adequately recovered from major surgery or have ongoing surgical complications
- •Has uncontrolled or significant cardiovascular disorder
- •Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), or any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren’s syndrome, sarcoidosis, etc), or prior pneumonectomy
- •Participants who have adverse events (AEs) (other than alopecia) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline
- •Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection (including Human immunodeficiency virus (HIV) infection)
- •Has clinically significant corneal disease
- •Known additional malignancy that is progressing or has required active treatment within the past 3 years
- •Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- •Evidence of any leptomeningeal disease
结局指标
主要结局
Objective Response Rate (ORR)
Objective Response Rate (ORR)
Number of participants who experience one or more adverse events (AEs)
Number of participants who experience one or more adverse events (AEs)
Number of participants who discontinue study intervention due to an AE
Number of participants who discontinue study intervention due to an AE
次要结局
- Duration of Response (DOR)
- Progression-free Survival (PFS)
- Overall Survival (OS)
研究者
Mark Shamoun
Scientific
Merck Sharp & Dohme LLC
研究点 (18)
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