A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Официальное название

Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Обзор

In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.

Вмешательства

• Биопрепарат Ris-Rez
  Ris-Rez will be administered
• Препарат Topotecan
  Topotecan will be administered

Первичные конечные точки

• Overall Survival (OS) [Срок оценки: Up to approximately 113 weeks]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 139 weeks]
• Duration of Response (DoR) [Срок оценки: Up to approximately 139 weeks]
• Progression-free survival (PFS) [Срок оценки: Up to approximately 139 weeks]
• Disease control rate (DCR) 12 [Срок оценки: Up to approximately 11 weeks]
• Brain PFS [Срок оценки: Up to approximately 139 weeks]
• Brain DoR [Срок оценки: Up to approximately 139 weeks]
• Brain ORR [Срок оценки: Up to approximately 139 weeks]
• Brain DCR12 [Срок оценки: Up to approximately 11 weeks]
• Time to brain progression [Срок оценки: Up to approximately 139 weeks]
• Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity [Срок оценки: Up to approximately 139 weeks]
• Number of participants with AEs leading to dose modifications or study intervention discontinuation [Срок оценки: Up to approximately 139 weeks]
• Number of participants with a change from baseline in vital signs [Срок оценки: Baseline (Day -1) and up to approximately 139 weeks]

Критерии участия

Критерии включения

Participants are eligible to be included in the study only if all of the following criteria apply:

• Adults >18 or the minimum legal adult age at the time the informed consent form is signed
• Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
• Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of >30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible.
• Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.
• Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.
• Has adequate organ function and an ECOG performance status of 0 or 1

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

• Pathological diagnosis of complex SCLC or transformed SCLC.
• Limited stage small cell lung cancer at diagnosis
• Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.
• Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
• Has severe, uncontrolled or active cardiovascular disorders.
• Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
• Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV).
• Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases.
• Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids.
• Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease),
• Has active Hepatitis B or Hepatitis C

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

Япония · 17 центров

• GSK Investigational Site — Fukuoka
• GSK Investigational Site — Hokkaido
• GSK Investigational Site — Ishikawa
• GSK Investigational Site — Kagoshima
• GSK Investigational Site — Kanagawa
• GSK Investigational Site — Kanagawa
• GSK Investigational Site — Kochi
• GSK Investigational Site — Kyoto
• … и ещё 9 центров

Испания · 10 центров

Список центров уточняется — проверьте первичный протокол.

Германия · 9 центров

• GSK Investigational Site — Karlsruhe
• GSK Investigational Site — Augsburg
• GSK Investigational Site — Chemnitz
• GSK Investigational Site — Esslingen am Neckar
• GSK Investigational Site — Löwenstein
• GSK Investigational Site — Lübeck
• GSK Investigational Site — München
• GSK Investigational Site — Nuremberg
• … и ещё 1 центр

Turkey (Türkiye) · 9 центров

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South Korea · 8 центров

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Бразилия · 7 центров

• GSK Investigational Site — Barretos
• GSK Investigational Site — CuritibaPR
• GSK Investigational Site — Florianópolis
• GSK Investigational Site — Porto Alegre
• GSK Investigational Site — Porto Alegre
• GSK Investigational Site — Rio de Janeiro
• GSK Investigational Site — São Paulo

Аргентина · 6 центров

• GSK Investigational Site — Mar del Plata
• GSK Investigational Site — Buenos Aires
• GSK Investigational Site — Ciudad Autonoma de Buenos Aire
• GSK Investigational Site — Ciudad Autonoma de Buenos Aire
• GSK Investigational Site — Rosario
• GSK Investigational Site — Vicente López

Греция · 6 центров

• GSK Investigational Site — Athens
• GSK Investigational Site — Athens
• GSK Investigational Site — Athens
• GSK Investigational Site — Heraklion
• GSK Investigational Site — Pylaia Thessaloniki
• GSK Investigational Site — Pylaia Thessaloniki

Венгрия · 6 центров

• GSK Investigational Site — Budapest
• GSK Investigational Site — Farkasgyepű
• GSK Investigational Site — Gyöngyös
• GSK Investigational Site — Kecskemét
• GSK Investigational Site — Székesfehérvár
• GSK Investigational Site — Törökbálint

Италия · 6 центров

• GSK Investigational Site — Bergamo
• GSK Investigational Site — Milan
• GSK Investigational Site — Orbassano
• GSK Investigational Site — Pisa
• GSK Investigational Site — Siena
• GSK Investigational Site — Verona

Румыния · 6 центров

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Болгария · 5 центров

• GSK Investigational Site — Pleven
• GSK Investigational Site — Plovdiv
• GSK Investigational Site — Rousse
• GSK Investigational Site — Sofia
• GSK Investigational Site — Sofia

Польша · 5 центров

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Канада · 4 центра

• GSK Investigational Site — Ottawa
• GSK Investigational Site — Toronto
• GSK Investigational Site — Montreal
• GSK Investigational Site — Montreal

Мексика · 4 центра

• GSK Investigational Site — Guadajalara
• GSK Investigational Site — Mexico City
• GSK Investigational Site — Mexico City
• GSK Investigational Site — San Pedro Garza García

Австралия · 3 центра

• GSK Investigational Site — Blacktown
• GSK Investigational Site — St Leonards
• GSK Investigational Site — Nedlands

Франция · 3 центра

• GSK Investigational Site — Boulogne-Billancourt
• GSK Investigational Site — Grenoble
• GSK Investigational Site — Saint-Herblain

Великобритания · 3 центра

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Израиль · 2 центра

• GSK Investigational Site — Jerusalem
• GSK Investigational Site — Tel Aviv

Португалия · 2 центра

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Швейцария · 2 центра

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Финляндия · 1 центр

• GSK Investigational Site — Vaasa

Ирландия · 1 центр

• GSK Investigational Site — Dublin

Швеция · 1 центр

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Идентификаторы

NCT: NCT07099898 · 223674 · 2025-521627-78-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗