KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Tumor Imaging, Tumor Tissue Collection, Blood Sample Collection.
- Кому может быть актуально
- Состояния в реестре: Carcinoma, Non-Small-Cell Lung. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Венгрия, Израиль, Италия, Польша +4
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)
Обзор
This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.
Подробное описание
The following pembrolizumab substudies will evaluate the efficacy of different investigational agents in combination with pembrolizumab given in sequence or in combination with pembrolizumab PLUS chemotherapy:
* KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A) - NCT04165070 * KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B) - NCT04165083 * KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated with anti-PD-(L)1 Therapy (MK-3475-01C) - NCT04165096 * KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E) - NCT06788912 * KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Second-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations (MK-3475-01F) - NCT07286149 * KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01G) - NCT06731907 * KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants with Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H) - NCT06780085 * 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) (MK-3475-01I) - NCT06780098 * KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations (MK-3475-01J) - NCT07252739
Вмешательства
- Диагностический тест Tumor Imaging
Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan. - Процедура Tumor Tissue Collection
Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue. - Процедура Blood Sample Collection
Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)
Первичные конечные точки
- Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% [Срок оценки: Up to approximately 1 month]
- Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC [Срок оценки: Up to approximately 1 month]
Критерии участия
Критерии включения
The main inclusion criteria include but are not limited to the following:
- Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
- Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
Критерии исключения
The main exclusion criteria include but are not limited to the following:
- Has an active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has an active infection requiring systemic therapy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 18 центров
- Banner MD Anderson Cancer Center ( Site 0001) — Gilbert
- City of Hope ( Site 0014) — Duarte
- UCSF Medical Center at Mission Bay ( Site 0007) — San Francisco
- Georgetown University ( Site 0036) — Washington D.C.
- University of Kentucky Markey Cancer Center ( Site 0019) — Lexington
- MedStar Franklin Square Medical Center ( Site 0033) — Baltimore
- Massachusetts General Hospital ( Site 0003) — Boston
- Dana Farber Cancer Institute ( Site 0002) — Boston
- … и ещё 10 центров
Израиль · 7 центров
- Soroka Medical Center ( Site 0072) — Beersheba
- Rambam Health Care Campus-Oncology ( Site 0076) — Haifa
- Shaare Zedek Medical Center ( Site 0075) — Jerusalem
- Meir Medical Center ( Site 0071) — Kfar Saba
- Rabin Medical Center ( Site 0074) — Petah Tikva
- Chaim Sheba Medical Center ( Site 0070) — Ramat Gan
- Sourasky Medical Center ( Site 0077) — Tel Aviv
Украина · 4 центра
- COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND — Cherkasy
- Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Fra — Ivano-Frankivsk
- ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461) — Rivne
- Uzhhorod Multispecialty City Clinical Hospital ( Site 0462) — Uzhhorod
Венгрия · 3 центра
- Petz Aladar Megyei Oktato Korhaz ( Site 0062) — Győr
- Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) — Szolnok
- Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) — Budapest
Италия · 3 центра
- Azienda Ospedaliera Universitaria Careggi ( Site 0173) — Florence
- IRCCS Ospedale San Raffaele ( Site 0171) — Milan
- Policlinico Gemelli di Roma ( Site 0174) — Roma
Польша · 3 центра
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Kl — Warsaw
- Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) — Gdansk
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site — Koszalin
South Korea · 3 центра
- Seoul National University Bundang Hospital ( Site 0081) — Seongnam-si
- Severance Hospital ( Site 0080) — Seoul
- Samsung Medical Center ( Site 0082) — Seoul
Испания · 3 центра
- ICO L Hospitalet ( Site 0090) — L'Hospitalet de Llobregat
- Hospital Clinic de Barcelona ( Site 0092) — Barcelona
- Hospital Universitario Quiron Madrid ( Site 0091) — Madrid
Тайвань · 3 центра
- Changhua Christian Hospital ( Site 0181) — Changhua
- Taipei Medical University Hospital ( Site 0180) — Taipei
- Chang Gung Medical Foundation-Linkou Branch ( Site 0182) — Taoyuan
Идентификаторы
NCT: NCT04165798 · 3475-U01 · MK-3475-U01 · KEYMAKER-U01