A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)

Официальное название

A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer

Обзор

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body. A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy. * Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing. * Immunotherapy is a treatment that helps the immune system fight cancer. Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate. * T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells. * A T-cell is a type of white blood cell, which are cells that help the body fight infection. * An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of combining gocatamig and I-DXd and if people tolerate them together * If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away

Подробное описание

In Part A, participants will be allocated to Arm 1 or Arm 2 per investigator's discretion. In Part B, participants will be allocated to Arm 1 per investigator's discretion and randomized to Arms 2, 3, and 4.

Вмешательства

• Препарат Gocatamig
  Intravenous (IV) administration
• Препарат I-DXd
  IV administration
• Препарат Atezolizumab
  IV administration
• Препарат Carboplatin
  IV administration
• Препарат Etoposide
  IV administration
• Препарат Rescue Medications
  Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.

Первичные конечные точки

• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 58 months]
• Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) [Срок оценки: Up to approximately 21 days]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 58 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 58 months]

Вторичные конечные точки (12)

• Disease Control Rate (DCR) [Срок оценки: Up to approximately 58 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 58 months]
• Progression-Free Survival (PFS) [Срок оценки: Up to approximately 58 months]
• Overall Survival (OS) [Срок оценки: Up to approximately 58 months]
• Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig [Срок оценки: At designated time points (up to approximately 58 months)]
• AUCt of I-DXd [Срок оценки: At designated time points (up to approximately 58 months)]
• AUCt of Deruxtecan (DXd) [Срок оценки: At designated time points (up to approximately 58 months)]
• AUCt of Anti-B7-H3 Antibody [Срок оценки: At designated time points (up to approximately 58 months)]
• Area Under the Steady-State Concentration-Time Curve Over the Dosing Interval t (AUCt,ss) of Gocatamig [Срок оценки: At designated time points (up to approximately 58 months)]
• AUCt,ss of I-DXd [Срок оценки: At designated time points (up to approximately 58 months)]
• AUCt,ss of DXd [Срок оценки: At designated time points (up to approximately 58 months)]
• AUCt,ss of Anti-B7-H3 Antibody [Срок оценки: At designated time points (up to approximately 58 months)]

Критерии участия

Критерии включения

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

• Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC)
• For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only:

• Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1/Ligand 1 (anti PD-1/L1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment
• No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
• No other prior systemic ES-SCLC therapy allowed
• Rechallenge therapy counts as an additional line and leads to exclusion
• For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed
• Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if > 6 months have passed since the end of previous therapy and progression
• Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
• Measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation

Критерии исключения

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

• Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
• Has history of clinically significant intracranial bleeding or spinal cord bleeding
• Has active neurologic paraneoplastic syndrome
• Has history of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF), and/or uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention
• Has other uncontrolled or significant protocol specified cardiovascular disease
• Has history of arterial thrombosis within 6 months before the first dose of study intervention
• Has chronic liver disease
• Has history of allogeneic tissue/solid organ transplant
• Has history of leptomeningeal disease
• Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
• Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation/randomization (or first dose), or is anticipated to require a major surgical procedure during the study

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

Открытое

Основная цель

Лечение

Центры проведения

США · 13 центров

• Providence Medical Foundation ( Site 0124) — Santa Rosa
• University of Colorado, Anschutz Cancer Pavilion ( Site 0125) — Aurora
• Orlando Health Cancer Institute ( Site 0108) — Orlando
• Saint Elizabeth Medical Center Edgewood ( Site 0112) — Edgewood
• Washington University School of Medicine ( Site 0134) — St Louis
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101) — Hackensack
• Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107) — Portland
• Avera Cancer Institute- Research ( Site 0104) — Sioux Falls
• … и ещё 5 центров

Китай · 8 центров

• Beijing Cancer Hospital ( Site 1604) — Пекин
• Southern Medical University Nanfang Hospital ( Site 1608) — Гуанчжоу
• Jiangmen Central Hospital ( Site 1611) — Jiangmen
• The First Affiliated Hospital of Nanchang University ( Site 1610) — Nanchang
• Shanghai East Hospital ( Site 1600) — Шанхай
• Sichuan Cancer hospital. ( Site 1609) — Чэнду
• The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602) — Ханчжоу
• Taizhou Hospital of Zhejiang Province ( Site 1601) — Taizhou

South Korea · 4 центра

• Seoul National University Hospital ( Site 1402) — Seoul
• Severance Hospital Yonsei University Health System ( Site 1403) — Seoul
• Asan Medical Center ( Site 1404) — Seoul
• Samsung Medical Center ( Site 1401) — Seoul

Испания · 4 центра

• Hospital San Pedro ( Site 1004) — Logroño
• Hospital Universitario Insular de Gran Canaria ( Site 1002) — Las Palmas de Gran Canaria
• Hospital Universitari Vall d'Hebron ( Site 1001) — Barcelona
• Hospital Universitario Gregorio Maranon ( Site 1003) — Madrid

Аргентина · 3 центра

• CEMIC ( Site 1903) — Caba.
• Hospital Austral ( Site 1901) — Pilar
• Sanatorio Parque ( Site 1900) — Rosario

Чили · 3 центра

• FALP ( Site 0200) — Santiago
• Pontificia Universidad Catolica de Chile ( Site 0202) — Santiago
• Bradfordhill ( Site 0201) — Santiago

Италия · 3 центра

• IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702) — Meldola
• Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701) — Milan
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma

Таиланд · 3 центра

• Faculty of Medicine Siriraj Hospital ( Site 3000) — Bangkoknoi
• Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002) — Dusit
• Songklanagarind hospital ( Site 3001) — Hat Yai

Израиль · 2 центра

• Rambam Health Care Campus ( Site 0602) — Haifa
• Sheba Medical Center ( Site 0601) — Ramat Gan

Германия · 1 центр

• Universitaetsklinikum Jena ( Site 0403) — Jena

Греция · 1 центр

• European Interbalkan Medical Center ( Site 0500) — Thessaloniki

Идентификаторы

NCT: NCT07227597 · 6070-003 · MK-6070-003 · U1111-1318-5025 · 2025-521032-11-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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