A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Официальное название

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Обзор

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn: * About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments

Подробное описание

This is a substudy of the master protocol MK-3475-U01 (KEYMAKER-U01) - NCT04165798.

Per amendment 3, the MK-1084 + Cetuximab arm was discontinued.

Вмешательства

• Препарат MK-1084
  Oral administration
• Биопрепарат Patritumab deruxtecan
  IV infusion
• Биопрепарат Sacituzumab tirumotecan
  IV Infusion
• Биопрепарат Cetuximab
  IV Infusion
• Препарат Rescue Medications
  Participants receive rescue medication at the investigator's discretion for prevention of nausea and vomiting, per approved product label. Recommended rescue medications are histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent), 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist and corticosteroid.

Первичные конечные точки

• Number of Participants Who Experience a Dose Limiting Toxicity (DLT) [Срок оценки: Up to 42 days]
• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 63 months]
• Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 62 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 63 months]

Вторичные конечные точки (5)

• Duration of Response (DOR) [Срок оценки: Up to approximately 63 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 71 months]
• Area Under the Curve From Time 0 to the End of the Dosing Interval (AUC tau) [Срок оценки: Predose and at designated time points post-dose (up to approximately 63 months)]
• Maximum Plasma Concentration (Cmax) [Срок оценки: Predose and at designated time points post-dose (up to approximately 63 months)]
• Minimum Observed Concentration (Ctrough) [Срок оценки: Predose and at designated time points post-dose (up to approximately 63 months)]

Критерии участия

Критерии включения

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

• Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC)
• Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations
• Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy
• Has provided tumor tissue for biomarker analysis from an archival sample or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
• Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol

Критерии исключения

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

• Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
• Has evidence of any leptomeningeal disease
• Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
• Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or current ILD, or suspected ILD
• Has an active infection requiring systemic therapy
• Has not adequately recovered from major surgery or has 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

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Clermont Oncology Center ( Site 0041) — Clermont
• University of Illinois Hospital & Health Sciences System ( Site 0044) — Chicago
• Providence Portland Medical Center ( Site 0043) — Portland
• Providence Oncology and Hematology Care Clinic - Westside ( Site 0059) — Portland

Бразилия · 4 центра

• Hospital São Lucas da PUCRS ( Site 0283) — Porto Alegre
• Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0282) — Barretos
• Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0286) — São José do Rio Preto
• Hospital Paulistano ( Site 0280) — São Paulo

Чили · 3 центра

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

Греция · 3 центра

• THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0204) — Athens
• Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0205) — Athens
• Papageorgiou General Hospital of Thessaloniki ( Site 0206) — N.Efkarpia

Гонконг · 3 центра

• Queen Mary Hospital ( Site 0230) — Гонконг
• Hong Kong United Oncology Centre ( Site 0232) — Jordan
• Prince of Wales Hospital ( Site 0231) — Shatin

Израиль · 3 центра

• Shaare Zedek Medical Center ( Site 0186) — Jerusalem
• Meir Medical Center ( Site 0181) — Kfar Saba
• Sheba Medical Center ( Site 0180) — Ramat Gan

Испания · 3 центра

• Institut Català d'Oncologia - L'Hospitalet ( Site 0090) — Hospitalet
• Hospital Clinic de Barcelona ( Site 0092) — Barcelona
• Hospital Universitario Virgen Macarena ( Site 0093) — Seville

Китай · 1 центр

• Guangdong Provincial People s Hospital ( Site 0300) — Гуанчжоу

Германия · 1 центр

• UniversitaetsklInikum Tuebingen ( Site 0192) — Tübingen

Италия · 1 центр

• IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0176) — Meldola

South Korea · 1 центр

• Severance Hospital, Yonsei University Health System ( Site 0080) — Seoul

Идентификаторы

NCT: NCT07286149 · 3475-01F · MK-3475-01F · 2024-512248-47-00 · U1111-1304-4707

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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