Идёт набор NCT07144280

A Study to Learn About the Study Medicine Called PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)

Фаза III С лечением Non-small Cell Carcinoma Non-Small Cell Lung Cancer Metastatic 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: PF-08046054, Docetaxel monotherapy.
Кому может быть актуально: Состояния в реестре: Non-small Cell Carcinoma, Non-Small Cell Lung Cancer Metastatic, 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, Аргентина, Австралия, Бельгия, Бразилия +24
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)

Обзор

The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation. Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.

Вмешательства

Препарат PF-08046054
Antibody Drug Conjugate Participants will receive PF-08046054, administered as an IV infusion.
Препарат Docetaxel monotherapy
Participants will receive Docetaxel, administered as an IV infusion.

Первичные конечные точки

Overall Survival [Срок оценки: Approximately 5 years]

Вторичные конечные точки (12)

Progression Free Survival (PFS) assessed by blinded independent central review (BICR) [Срок оценки: Approximately 5 years]
Objective Response Rate as assessed by BICR [Срок оценки: Approximately 5 years]
Progression Free Survival as assessed by Investigator [Срок оценки: Approximately 5 years]
Objective Response Rate (ORR) as assessed by Investigator [Срок оценки: Approximately 5 years]
Duration of Response as assessed by BICR [Срок оценки: Approximately 5 years]
Duration of Response as assessed by Investigator [Срок оценки: Approximately 5 years]
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation [Срок оценки: Through 90 days after the last study intervention; Approximately 5 years]
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [Срок оценки: Approximately 5 years]
Mean scores and Change from baseline in physical functioning and role functioning scores on the EORTC QLQ-C30 [Срок оценки: Approximately 5 years]
Mean scores and Change from Baseline in dyspnea, cough, and chest pain scores on the EORTC Quality of Life Cancer Questionnaire - Lung Cancer 13 QLQ-LC13 [Срок оценки: Approximately 5 years]
Time to definitive deterioration (TTdD) in in the global health status/QoL score on the EORTC QLQ-C30 [Срок оценки: Approximately 5 years]
TTdD in physical functioning and role functioning scores on the EORTC QLQ-C30 [Срок оценки: Approximately 5 years]

Критерии участия

Критерии включения

Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.
PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.
Participants who have NSCLC with known AGAs are permitted.
Able to provide any of the following tumor tissues for biomarker analysis:

Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or
De novo biopsy from a tumor lesion, if medically feasible.
Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:

Participants with no known AGAs must fulfill 1 of the following conditions:

Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.

Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:

Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.
May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).

Критерии исключения

History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \[OS\] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and/or radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:

The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least >14 days prior to randomization (if requiring steroid treatment).
No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery.
Time since CNS-directed treatment is ≥28 days prior to randomization.
Participants with a history of leptomeningeal metastasis are excluded.
Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.
Previous receipt of an MMAE-containing agent or prior docetaxel.

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.

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