Symbiotic-Lung-04: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Extensive-Stage Small Cell Lung Cancer

Официальное название

A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER

Обзор

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with extensive-stage small cell lung cancer (ES-SCLC), a fast-growing type of lung cancer that has spread widely in the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have extensive-stage small cell lung cancer confirmed by lab tests. * Have not received chemotherapy or radiation for this type of lung cancer. * Be in good physical condition and have healthy organs based on medical tests. The study has two parts: * In the first part, researchers will check how safe the study medicine is and how well people tolerate it when given with chemotherapy. * In the second part, they will compare study medicine plus chemotherapy to another approved treatment (atezolizumab plus chemotherapy) to see which works better. Participants will receive the treatment through IV infusions (medicine given directly into a vein). The treatment will be given in repeated time periods called cycles. Some participants will continue receiving the study medicine alone after the initial treatment.

Вмешательства

• Препарат PF-08634404
  Concentrate for solution for infusion
• Биопрепарат Atezolizumab
  Injection for intravenous use
• Препарат Chemotherapy
  Injection for intravenous use

Первичные конечные точки

• Phase 2: Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1] based on the investigator's assessment [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Phase 2: Number of participants with treatment-emergent adverse events [Срок оценки: Up to 90 days after the last dose of treatment]
• Phase 3: Overall Survival (OS) [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]

Вторичные конечные точки (12)

• Duration of Response (DOR) as assessed by Investigator based on RECIST v1.1 [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1 [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Number of participants with Laboratory abnormalities [Срок оценки: Up to 90 days after the last dose of treatment]
• Phase 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT) [Срок оценки: Up to 90 days after the last dose of treatment]
• Pharmacokinetics: Serum concentrations of PF-08634404 [Срок оценки: Up to 37 days after the last dose of treatment]
• Incidence of antidrug antibody against PF-08634404 [Срок оценки: Up to 37 days after the last dose of treatment]
• Phase 2: Overall Survival [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Phase 3: PFS using RECIST v1.1 as assessed by blinded independent central review (BICR) [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Phase 3: Confirmed ORR using RECIST v1.1 as assessed by BICR [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Phase 3: DOR using RECIST v1.1 as assessed by BICR [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Phase 3: Mean scores and Change from baseline in the global health status/quality of life (QoL), function, and symptom scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]
• Phase 3: Mean scores and Change from Baseline on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13) [Срок оценки: Up to approximately 2 years after completion of study treatment of last study participant]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).
• Participants have not received systemic therapy (chemotherapy, radiotherapy, chemoradiation) for ES-SCLC.
• Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
• Have at least one measurable lesion as the targeted lesion based on RECIST V1.1.
• Eastern Cooperative Oncology Group performance status of 0 or 1.
• Adequate organ function

Критерии исключения

• known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
• Leptomeningeal disease
• Clinically significant risk of hemorrhage or fistula
• history of another malignancy within 3 years
• active autoimmune diseases requiring systemic treatment within the past 2 years

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 45 центров

• Highlands Oncology Group — Fayetteville
• Highlands Oncology Group — Rogers
• Highlands Oncology Group — Springdale
• BRCR Coral Springs — Coral Springs
• Mid Florida Hematology and Oncology Center — Orange City
• BRCR Global - Tamarac — Tamarac
• University Hospitals Cleveland Medical Center — Cleveland
• Texas Oncology - DFW — Arlington
• … и ещё 37 центров

Испания · 7 центров

• HT Médica Jaen LAs Nieves — Jaén
• Hospital Jerez de la Frontera — Jerez de la Frontera
• Hospital Universitario 12 de Octubre — Madrid
• Parc de Salut Mar - Hospital del Mar — Barcelona
• CETIR — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario de Jaen — Jaén

Пуэрто-Рико · 4 центра

• Doctor's Center Hematology & Oncology Group — Manati
• Pan American Center for Oncology Trials, LLC - Mayaguez Office Mayaguez Medical Center — Mayagüez
• Pan American Center for Oncology Trials, LLC — San Juan
• Hospital Oncologico Dr. Isaac Gonzalez-Martinez — San Juan

Италия · 3 центра

• Centro di Riferimento Oncologico (CRO) IRCCS — Aviano
• IRCCS Istituto Nazionale dei Tumori Regina Elena — Roma
• Azienda Ospedaliero-Universitaria San Luigi Gonzaga — Orbassano

Япония · 3 центра

• Kansai Medical University Hospital — Hirakata
• Shizuoka Cancer Center — Nagaizumi-cho
• Japanese Foundation for Cancer Research — Kotoku

Тайвань · 3 центра

• National Cheng Kung University Hospital — Tainan
• National Taiwan University Hospital — Taipei
• Taipei Medical University Hospital — Taipei

Австралия · 2 центра

• Westmead Hospital — Westmead
• Sunshine Coast University Hospital — Birtinya

Китай · 2 центра

• Guangdong Provincial People's Hospital — Гуанчжоу
• Fudan University Shanghai Cancer Center — Шанхай

Франция · 2 центра

• Gustave Roussy — Villejuif
• Hôpital Ambroise Paré — Boulogne-Billancourt

Германия · 2 центра

• Marien Hospital Düsseldorf — Düsseldorf
• Krankenhaus Nordwest GmbH — Frankfurt am Main

Идентификаторы

NCT: NCT07226999 · C6461004 · 2025-523522-41-00 · Symbiotic-Lung-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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