Идёт набор NCT07365319

A Safety and Efficacy Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer.

Фаза II / Фаза III С лечением Non Small Cell Lung Cancer (Squamous or Non Squamous) Stage 4 NSCLC

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: EIK1001, Pembrolizumab (KEYTRUDA®), Placebo, Paclitaxel + Carboplatin.
Кому может быть актуально: Состояния в реестре: Non Small Cell Lung Cancer (Squamous or Non Squamous), Stage 4 NSCLC. 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, Испания
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 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination With Pembrolizumab and Chemotherapy in Participants With Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).

Обзор

This is a study to evaluate the safety and efficacy of EIK1001 administered intravenously in combination with pembrolizumab and histologically appropriate chemotherapy for patients with stage 4 NSCLC.

Подробное описание

This is a global, multicenter, double-blind, placebo-controlled, randomized adaptive Phase 2/3 study to evaluate the clinical activity and safety of EIK1001 administered IV in combination with pembrolizumab and histologically appropriate chemotherapy (pemetrexed plus either carboplatin or cisplatin) to participants with Stage 4 non-squamous or (carboplatin plus either paclitaxel or nab-paclitaxel) for participants with squamous NSCLC who have not received prior systemic therapy. The study is conducted in 2 phases (Phase 2 and Phase 3) and analyzed in 3 parts (dose optimization, dose expansion and confirmatory hypothesis testing).

Вмешательства

Препарат EIK1001
EIK1001 is a Toll like receptor 7/8 (TLR 7/8) dual agonist
Препарат Pembrolizumab (KEYTRUDA®)
PD-1 inhibitor
Препарат Placebo
Placebo control
Препарат Paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Препарат Nab-paclitaxel + Carboplatin
SOC Chemotherapy for squamous NSCLC
Препарат Pemetrexed + Cisplatin /Carboplatin
SOC Chemotherapy for non-squamous NSCLC

Первичные конечные точки

Progression-free survival (PFS) [Срок оценки: Through study completion, up to 6 years]
Overall survival (OS) [Срок оценки: Through study completion, up to 10 years]
Objective Response (OR) [Срок оценки: Through study completion, up to 6 years]

Вторичные конечные точки (6)

Objective response (OR) [Срок оценки: Up to 6 years]
Duration of response (DOR) [Срок оценки: Up to 6 years]
Progression-free survival (PFS) by Investigator [Срок оценки: Up to 6 years]
Overall Response Rate (ORR) by Investigator [Срок оценки: Up to 6 years]
Duration of Response (DOR) by Investigator [Срок оценки: Up to 6 years]
Incidence of Adverse Events (AEs) [Срок оценки: Up to 2.5 years]

Критерии участия

Критерии включения

Participant must be ≥ 18 years old at the time of signing the informed consent.
Participant has a life expectancy of at least 3 months.
Participant has histologically or cytologically confirmed Stage 4 NSCLC predominately squamous or non-squamous) and is considered a candidate for standard therapy with pembrolizumab and chemotherapy. Participants with NSCLC-NOS (not otherwise specified) will be considered as non-squamous NSCLC.
Participant must have documented evidence that mutation-directed therapy is not indicated, based on the absence of tumor-activating mutations or fusions (e.g., but not limited to EGFR, ALK, RET, ROS1, BRAF) for which approved first-line targeted therapies are available to the participant in their respective country.
Participant has at least 1 lesion with measurable disease at Baseline according to RECIST 1.1 as determined locally. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
Participant has not received prior systemic therapy for advanced/metastatic NSCLC.

Note: Participants who received adjuvant or neoadjuvant treatment (after surgery and/or radiation therapy) and developed recurrent or metastatic disease more than 1 year after completing therapy are eligible.

Participant has an ECOG Performance Status of 0 to 1 assessed no more than 10 days before start of the treatment.
Participant has tumor tissue available for PD-L1 testing from a site that was not radiated prior to biopsy, and was obtained, ideally, after diagnosis of metastatic disease. Biopsies obtained prior to receipt of adjuvant/neoadjuvant chemotherapy will be permitted if recent biopsy is not feasible (provided the specimen is < 3yrs old).

Критерии исключения

has small cell elements present histologically and/or the tumors are not predominantly non-squamous or squamous NSCLC.
is currently actively enrolled in or has recently participated in a study of an investigational agent and received investigational therapy within 4 weeks or 5 half-lives (whichever is longer) of administration of EIK1001 or placebo.
has had major surgery (< 3 weeks prior to the first dose of study intervention administration).
has received a live-virus vaccination within 30 days of the start of study intervention initiation.
has received radiation therapy within 7 days of the first dose of study intervention administration.
has completed palliative radiotherapy within 7 days of the first dose of study intervention administration.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет