Идёт набор NCT06712316

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Фаза II / Фаза III С лечением Non-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, Pembrolizumab, Carboplatin, Pemetrexed.
Кому может быть актуально: Состояния в реестре: Non-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, Бельгия, Бразилия, Болгария +15
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 II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer

Обзор

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Подробное описание

Each substudy contains a Phase 2 part followed by a Phase 3 part. Participants will be randomized to one of two dose levels of pumitamig (BNT327) plus chemotherapy for the Phase 2 part of each substudy. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants.

The planned study duration per study participant is up to 64 months.

Вмешательства

Препарат Pumitamig
Intravenous infusion
Препарат Pembrolizumab
Intravenous infusion
Препарат Carboplatin
Intravenous infusion
Препарат Pemetrexed
Intravenous infusion
Препарат Paclitaxel
Intravenous infusion

Первичные конечные точки

Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs [Срок оценки: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit]
Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) [Срок оценки: From the first dose of IMP to the 90-day Follow-Up Visit]
Phase 2 - Objective response rate (ORR) [Срок оценки: Up to approximately 2 years]
Phase 2 - Best percentage change from baseline in tumor size [Срок оценки: Up to approximately 2 years]
Phase 3 - Progression free survival (PFS) assessed by blinded independent central review (BICR) [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (12)

Phase 3 - Overall survival (OS) [Срок оценки: Up to approximately 5 years]
Phase 2 - Duration of Response (DOR) [Срок оценки: Up to approximately 2 years]
Phase 2 - Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
Phase 3 - PFS assessed by investigator [Срок оценки: Up to approximately 5 years]
Phase 3 - ORR [Срок оценки: Up to approximately 2 years]
Phase 3 - PFS rate as assessed by BICR [Срок оценки: At 6, 12, and 18 months]
Phase 3 - PFS rate as assessed by investigator [Срок оценки: At 6, 12, and 18 months]
Phase 3 - OS rate [Срок оценки: At 6, 12, 18, 24 months]
Phase 3 - Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life-score 30 Questionnaire (QLQ-C30) global health status/Quality-of-Life (QoL) score (Items 29 and 30) [Срок оценки: Up to approximately 5 years]
Phase 3 - Change from baseline in EORTC QLQ-C30 physical functioning [Срок оценки: Up to approximately 5 years]
Phase 3 - Change from baseline in coughing scale of the EORTC lung cancer-specific quality-of-life questionnaire (QLQ-LC29) [Срок оценки: Up to approximately 5 years]
Phase 3 - Change from baseline in shortness of breath scale of the EORTC QLQ-LC29 [Срок оценки: Up to approximately 5 years]

Критерии участия

Критерии включения

Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
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 Performance Status of 0 or 1.
Adequate organ function.

Критерии исключения

Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine component.
Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neo-adjuvant/adjuvant or locally advanced/metastatic setting.
Participants who received prior treatment with anti-VEGF monoclonal antibody, or 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 uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
Participants with significant risk of hemorrhage (per investigator clinical judgment).
Have superior vena cava syndrome or symptoms of spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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