Идёт набор NCT06712355

Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

Фаза III С лечением Extensive-stage Small-cell Lung Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Pumitamig, Atezolizumab, Etoposide, Carboplatin (or cisplatin if carboplatin is not tolerated).
Кому может быть актуально: Состояния в реестре: Extensive-stage Small-cell Lung Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Австралия, Китай, Франция, Германия +9
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase III, Multisite, Double-blinded Randomized Trial of BNT327 in Combination With Chemotherapy (Etoposide/Carboplatin) Compared to Atezolizumab in Combination With Chemotherapy (Etoposide/Carboplatin) in Participants With First-line Extensive-stage Small-cell Lung Cancer

Обзор

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

Подробное описание

There are two stages in this study: Stage 1 will have two treatment arms and one control arm, and Stage 2 will have a treatment arm and a control arm. The control arms in Stages 1 and 2 are the same.

Each stage of the study consists of a screening period (up to 21 days), an induction period followed by a maintenance period (until confirmed disease progression, intolerable toxicity, participant withdrawal, study termination or up to 2 years \[whichever occurs first\]), and a follow-up (FU) period for all participants (2 safety FU visits and survival FU visits).

In Stage 1, eligible participants will be randomized (1:1:1) to the arms. In Stage 2, participants will then be randomized (1:1) to the arms. The randomization will be stratified based on the following factors:

1. Brain or liver metastases per investigator assessment (presence versus absence); 2. Smoking status (smoker versus never-smoker); and 3. Geography.

Participants will be allowed to switch to cisplatin if carboplatin is not tolerated at the investigator's discretion.

Вмешательства

Препарат Pumitamig
Intravenous infusion
Препарат Atezolizumab
Intravenous infusion
Препарат Etoposide
Intravenous infusion and capsules
Препарат Carboplatin (or cisplatin if carboplatin is not tolerated)
Intravenous infusion

Первичные конечные точки

Overall survival (OS) [Срок оценки: Up to approximately 46 months]

Вторичные конечные точки (12)

Progression-free survival (PFS) [Срок оценки: Up to approximately 46 months]
Objective response rate (ORR) [Срок оценки: Up to approximately 46 months]
Duration of response (DOR) [Срок оценки: Up to approximately 46 months]
PFS rate based on investigator's assessment [Срок оценки: At 6, 12, and 18 months]
OS rate [Срок оценки: At 6, 12, 18, and 24 months]
Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship [Срок оценки: From the first dose of study treatment to the 90-Day Follow-up Visit]
Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs) [Срок оценки: From first to last dose of study treatment, i.e., up to 2 years]
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 questionnaire (QLQ-C30) Global Health status/Quality-of-Life score (Items 29 and 30) [Срок оценки: Up to approximately 46 months]
Change from baseline in EORTC QLQ-C30 physical functioning [Срок оценки: Up to approximately 46 months]
Change from baseline in coughing scale of the EORTC Quality-of-Life-Lung cancer 29 questionnaire (QLQ-LC29) [Срок оценки: Up to approximately 46 months]
Change from baseline in shortness of breath scale of the EORTC QLQ-LC29 [Срок оценки: Up to approximately 46 months]
Change from baseline in coughed up blood item of the EORTC QLQ-LC29 [Срок оценки: Up to approximately 46 months]

Критерии участия

Критерии включения

Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system combined with Veterans Administration Lung Study Group \[VALG\]'s two stage classification scheme). For AJCC tumor node metastasis staging system: AJCC 8th edition stage IV (T any, N any, M1a/b/c), or T3\~4 for multiple lung nodules or tumor/nodule volume that cannot be encompassed in a tolerable radiotherapy plan.
Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.
Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate hematologic and organ function as defined in the protocol.

Критерии исключения

Have histologically or cytologically confirmed SCLC with combined histologies.
Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

Within 2 weeks: small molecule agents with half-life of <7 days; radiation outside the thoracic cavity including whole brain radiation. Of note, other local radiation for brain lesions (not whole brain) is allowed; local radiation for bone lesions is allowed. Palliative bone radiation or brain stereotactic radiosurgery would not require a washout period, but participants should recover from radiotherapy-related toxicity.
Within 4 weeks: radiation involving the thoracic cavity; small molecule targeted agents with half-life of ≥7 days; monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies.
Have received prior treatment with anti-vascular endothelial growth factor (VEGF) monoclonal antibody, or programmed death (ligand)-1 (PD\[L\]-1)/VEGF bispecific antibody.
Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
Have the following central nervous system metastases:

Participants with untreated brain metastases that are symptomatic or large (e.g., greater than 2 cm).
Participants with treated central nervous system (CNS) metastases who are not neurologically stable or on steroids (at a dosage greater than 10 mg/Day of prednisone or an equivalent dose of other corticosteroid) within 7 days before initiating study treatment of this study.
Participants with known leptomeningeal metastases.
Have uncontrolled hypertension or poorly controlled diabetes prior to study treatment.
Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess for which an interval of 6 months must pass before study entry. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
Have a significant risk of hemorrhage (per investigator clinical judgment) as defined in the protocol.
Have superior vena cava syndrome or symptoms of spinal cord compression that requires urgent medical intervention.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

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 · 36 центров

ACRC Arizona Clinical Research Center — Tucson
Clermont Oncology Center — Clermont
Cancer Care Centers of Brevard, Inc — Palm Bay
Northside Hospital Atlanta — Atlanta
Illinois Cancer Specialists — Niles
Fort Wayne Medical Oncology and Hematology, Inc — Fort Wayne
McFarland Clinic — Ames
Helen G. Nassif Community Cancer Center — Cedar Rapids
… и ещё 28 центров

Китай · 34 центра

Jilin Cancer Hospital — Changchun
Affiliated Hospital of Hebei University — Baoding
Beijing Friendship Hospital, Capital Medical University — Пекин
Peking Union Medical College Hospital — Пекин
Beijing Chest Hospital,Capital Medical University — Пекин
The First Affiliated Hospital of Bengbu Medical College — Bengbu
Fujian Provincial Cancer Hospital — Фучжоу
Guangdong General Hospital — Гуанчжоу
… и ещё 26 центров

Turkey (Türkiye) · 22 центра