Substudy 01I: A Study of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I/KEYMAKER-U01I)

Официальное название

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)

Обзор

Researchers are looking for other ways to treat metastatic squamous non-small cell lung cancer (NSCLC). Squamous NSCLC is cancer that starts in squamous cells, which are flat cells that line the inside of the airways in the lungs. Metastatic means the cancer has spread to other parts of the body. Standard treatment (usual treatment) for metastatic squamous NSCLC is immunotherapy with or without chemotherapy. Immunotherapy is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. However, standard treatment may not work or may stop working to treat metastatic squamous NSCLC. Researchers want to learn if study treatments that are antibody drug conjugates (ADCs) can treat metastatic squamous NSCLC that did not respond (get smaller or go away) to standard treatment. An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goals of this study are to learn about: * The cancer response to the study treatments compared to chemotherapy * The safety of the study treatments and if people tolerate them This study is one of the substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).

Подробное описание

The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798

Вмешательства

• Биопрепарат R-DXD
  IV Infusion
• Биопрепарат I-DXD
  IV Infusion
• Препарат Docetaxel
  IV Infusion
• Препарат Rescue Medications
  Participants receive rescue medications consisting of a combination regimen to include corticosteroids with a 5-hydroxytryptamine subtype 3 receptor antagonist and/or a neurokinin-1 receptor antagonist, all per approved product label and following institutional standards or local guidelines.
• Препарат Rescue Medication
  Participants are premedicated with corticosteroids per approved product label and following institutional standards or local guidelines.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 81 months]
• Number of participants who experience one or more adverse events (AEs) [Срок оценки: Up to approximately 81 months]
• Number of participants who discontinue study intervention due to an AE [Срок оценки: Up to approximately 81 months]

Вторичные конечные точки (3)

• Duration of Response (DOR) [Срок оценки: Up to approximately 81 months]
• Progression-free Survival (PFS) [Срок оценки: Up to approximately 81 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 81 months]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

• Histologically or cytologically confirmed diagnosis of Stage IV squamous non-small cell lung cancer (NSCLC)
• Has documented disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1), as assessed by investigator after receiving an anti-programmed cell death protein 1 (anti-PD-1)/programmed cell death ligand 1 (PD-L1) treatment and platinum-based chemotherapy for Stage IV disease
• 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

Критерии исключения

The main exclusion criteria include but are not limited to the following:

• Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• 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
• Has clinically significant corneal disease
• Has previously received docetaxel as monotherapy or in combination with other therapies
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
• Evidence of any leptomeningeal disease
• Has one or more of the following indicators of interstitial lung disease (ILD)/pneumonitis: any history of ILD/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), current diagnosis of ILD, clinical or radiographic suspicion of ILD
• 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
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 8 центров

• Beijing Cancer Hospital ( Site 0301) — Пекин
• Chongqing University Cancer Hospital ( Site 0304) — Чунцин
• Fujian Provincial Cancer Hospital ( Site 0310) — Фучжоу
• Guangxi Medical University Cancer Hospital ( Site 0303) — Nanning
• Henan Cancer Hospital ( Site 0311) — Чжэнчжоу
• Nanjing Drum Tower Hospital JiangBei International Branch Hospital ( Site 0309) — Нанкин
• Shanghai Chest Hospital ( Site 0308) — Шанхай
• Shanghai Pulmonary Hospital ( Site 0300) — Шанхай

Израиль · 6 центров

• Rambam Health Care Campus ( Site 0076) — Haifa
• Shaare Zedek Medical Center ( Site 0075) — Jerusalem
• Meir Medical Center ( Site 0071) — Kfar Saba
• Rabin Medical Center ( Site 0074) — Petah Tikva
• Sheba Medical Center ( Site 0070) — Ramat Gan
• Sourasky Medical Center ( Site 0077) — Tel Aviv

Turkey (Türkiye) · 5 центров

• Ege Universitesi Hastanesi ( Site 0143) — Izmir
• Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0141) — Adana
• Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0140) — Ankara
• Ankara Bilkent Şehir Hastanesi. ( Site 0142) — Ankara
• Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0144) — Istanbul

Италия · 4 центра

• Azienda Ospedaliera Universitaria Careggi ( Site 0173) — Florence
• Ospedale San Raffaele. ( Site 0171) — Milan
• Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175) — Milan
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma

Польша · 4 центра

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0153) — Poznan
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w W — Warsaw
• Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) — Gdansk
• Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0152) — Koszalin

США · 3 центра

• University of Kentucky Chandler Medical Center ( Site 0019) — Lexington
• MedStar Franklin Square Medical Center ( Site 0033) — Baltimore
• Texas Oncology - DFW ( Site 8003) — Dallas

Чили · 3 центра

• Centro de Estudios Clínicos SAGA ( Site 0161) — Santiago
• FALP ( Site 0160) — Santiago
• Bradfordhill ( Site 0162) — Santiago

Греция · 3 центра

• EVANGELISMOS S.A ( Site 0206) — Athens
• THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204) — Athens
• European Interbalkan Medical Center-Oncology Department ( Site 0205) — Thessaloniki

Венгрия · 3 центра

• Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 0063) — Kecskemét
• Petz Aladar Egyetemi Oktato Korhaz ( Site 0062) — Győr
• Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet ( Site 0061) — Szolnok

Испания · 3 центра

• Institut Català d'Oncologia - L'Hospitalet ( Site 0090) — L'Hospitalet de Llobregat
• Hospital Clinic de Barcelona ( Site 0092) — Barcelona
• Hospital Universitario Quiron Madrid ( Site 0091) — Madrid

Германия · 2 центра

• UniversitaetsklInikum Tuebingen ( Site 0192) — Tübingen
• Charite-Universitaetsmedizin Berlin ( Site 0191) — Berlin

Идентификаторы

NCT: NCT06780098 · 3475-01I · MK-3475-01I · U1111-1314-2392 · 2024-518839-11-00 · KEYMAKER-01I

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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