A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 7
- 主要终点
- To compare MK-2870 to platinum-based
研究概览
简要总结
NSCLC remains a public health problem and the leading cause of cancer mortality
worldwide. EGFR mutations are commonly found in NSCLC, and patients with these
mutations eventually progress on current 1L treatment regimens using TKIs. New therapeutic
options need to be investigated for this population to improve both PFS and OS, especially in
patients who have progressed after current SOC practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Is an individual of any sex gender of at least 18 years of age at the time of providing the informed consent.
- •Have histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous NSCLC.
- •Advanced stage is defined as Stage IV or Stage III not eligible for curative resection or curative chemoradiation AJCC Version 8 or current version as applicable Have documentation of tumor activating EGFR mutation, exon 19del, L858R, G719X,S768I, or L861Q.
- •Have provided tissue sample core, incisional, or excisional biopsy of a tumor lesion not previously irradiated as soon as possible.
- •FFPE tissue blocks are preferred to slides.
- •Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer NSCLC Measurable disease per RECIST 1.1 as assessed by the local site investigator.
- •Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
- •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 Human immunodeficiency virus HIV infected participants must have well controlled HIV on antiretroviral therapy.
- •Life expectancy of at least 3 months.
排除标准
- •Predominantly squamous cell histology NSCLC.
- •History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- •Grade more than 2 peripheral neuropathy.
- •History of documented severe dry eye syndrome, severe Meibomian gland disease and or blepharitis, or corneal disease that prevents delays corneal healing.
- •Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
- •Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
- •Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- •Administration of killed vaccines is allowed.
- •Received radiation therapy to the lung that is 30 Gray within 6 months of the first dose of study intervention Known active central nervous system metastases and or carcinomatous meningitis.
- •History of noninfectious pneumonitis interstitial lung disease that required steroids or has current pneumonitis interstitial lung disease HIV infected participants with a history of Kaposis sarcoma and or Multicentric Castlemans Disease.
- •Concurrent active HBV and HCV infection History of allogeneic tissue solid organ transplant.
- •Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
结局指标
主要结局
To compare MK-2870 to platinum-based
时间窗: The time from randomization to the | first documented disease progression or | death due to any cause, whichever occurs | first
doublet chemotherapy with respect to PFS
时间窗: The time from randomization to the | first documented disease progression or | death due to any cause, whichever occurs | first
per RECIST 1.1 as assessed by BICR
时间窗: The time from randomization to the | first documented disease progression or | death due to any cause, whichever occurs | first
Hypothesis (H1): MK-2870 is superior to
时间窗: The time from randomization to the | first documented disease progression or | death due to any cause, whichever occurs | first
platinum-based doublet chemotherapy with
时间窗: The time from randomization to the | first documented disease progression or | death due to any cause, whichever occurs | first
respect to PFS per RECIST 1.1 as assessed
时间窗: The time from randomization to the | first documented disease progression or | death due to any cause, whichever occurs | first
by BICR
时间窗: The time from randomization to the | first documented disease progression or | death due to any cause, whichever occurs | first
次要结局
- Objective Response Rate (ORR)(Up to approximately 51 months)
- Duration of Response (DOR)(Up to approximately 51 months)
- Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline and up to approximately 6 years)
- Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30(Baseline and up to approximately 6 years)
- Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13)(Baseline and up to approximately 6 years)
- Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13(Baseline and up to approximately 6 years)
- Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30(Baseline and up to approximately 6 years)
- TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30(Baseline and up to approximately 6 years)
- TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13(Baseline and up to approximately 6 years)
- TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13(Baseline and up to approximately 6 years)
- Number of Participants Who Experience One or More Adverse Events (AEs)(up to approximately 6 years)
- Number of Participants Who Discontinue Study Treatment Due to an AE(up to approximately 6 years)
研究者
Dr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd