Идёт набор NCT06772623

Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations

Фаза I / Фаза II С лечением Non Small Cell Lung Carcinoma

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: Telisotuzumab Adizutecan, Budigalimab, Pembrolizumab, Pembrolizumab.
Кому может быть актуально: Состояния в реестре: Non Small Cell Lung Carcinoma. 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, Бельгия, 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

An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations

Обзор

Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC. Telisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Вмешательства

Препарат Telisotuzumab Adizutecan
Intravenous (IV) Infusion
Препарат Budigalimab
IV Infusion
Препарат Pembrolizumab
IV Injection
Препарат Pembrolizumab
IV Infusion
Препарат Carboplatin
IV Infusion
Препарат Pemetrexed
IV Infusion
Препарат Cisplatin
IV Infusion

Первичные конечные точки

Part 1: Dose-Limiting Toxicities (DLT)s of Telisotuzumab Adizutecan [Срок оценки: Up to Approximately 84 Days]
Part 2: Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to Approximately 33 Months]
Number of Participants with Adverse Events (AE)s [Срок оценки: Up to Approximately 33 Months]

Вторичные конечные точки (9)

Part 1 and Part 2: PFS as Assessed by Investigator [Срок оценки: Up to Approximately 33 Months]
Part 1 and Part 2: DOR as Assessed by Investigator [Срок оценки: Up to Approximately 33 Months]
Part 1 and Part 2: DC as Assessed by Investigator [Срок оценки: Up to Approximately 33 Months]
Part 1 and Part 2: Overall Survival (OS) [Срок оценки: Up to Approximately 33 Months]
Programmed Death Ligand 1 (PD-L1) and c-Met Subgroups: OR [Срок оценки: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: PFS [Срок оценки: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: OS [Срок оценки: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: DOR [Срок оценки: Up to Approximately 33 Months]
PD-L1 and c-Met Subgroups: DC [Срок оценки: Up to Approximately 33 Months]

Критерии участия

Критерии включения

Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.
Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.
For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.
For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.
Must have documented programmed death ligand 1 (PD-L1) status.
For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.
Must have adequate organ function.

Критерии исключения

Known uncontrolled metastases to the central nervous system.
History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.

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

Центры проведения

США · 27 центров

Mayo Clinic Hospital - Phoenix /ID# 272971 — Phoenix
Providence - St. Jude Medical Center /ID# 271414 — Fullerton
FOMAT Medical Research - Clinica mi Salud by Focil Med /ID# 274450 — Oxnard
UCLA - Santa Monica /ID# 271690 — Santa Monica
University Of Colorado - Anschutz Medical Campus /ID# 269069 — Aurora
Rocky Mountain Cancer Centers - Lone Tree /ID# 272603 — Lone Tree
Mayo Clinic Hospital Jacksonville /ID# 275073 — Jacksonville
Mid Florida Hematology And Oncology Center /ID# 273777 — Orange City
… и ещё 19 центров

Китай · 15 центров

Cancer Hospital - Chinese Academy of Medical Sciences /ID# 269715 — Пекин
Fujian Province Cancer Hospital /ID# 269150 — Фучжоу
Liuzhou People's hospital /ID# 269667 — Liuzhou
Henan Cancer Hospital /ID# 269668 — Чжэнчжоу
Union Hospital - Tongji Medical College /ID# 272286 — Ухань
Hunan Province Cancer Hospital /ID# 269679 — Чанша
Nanjing Drum Tower Hospital /ID# 269762 — Нанкин
The First Affiliated Hospital of Nanchang University /ID# 269190 — Nanchang
… и ещё 7 центров

Япония · 10 центров

NHO Nagoya Medical Center /ID# 272515 — Nagoya
Aichi Cancer Center /ID# 271978 — Nagoya
Hirosaki University Hospital /ID# 274410 — Hirosaki
Yokohama Municipal Citizen's Hospital /ID# 271979 — Yokohama
Kyoto University Hospital /ID# 272312 — Kyoto
Niigata University Medical and Dental Hospital /ID# 274448 — Niigata
Osaka Medical And Pharmaceutical University Hospital /ID# 273309 — Takatsuki
National Cancer Center Hospital /ID# 273192 — Chuo-Ku
… и ещё 2 центра

Turkey (Türkiye) · 10 центров