A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC)

Официальное название

A Randomized Phase 2 Platform Study to Evaluate Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for the Perioperative Treatment of Patients With Resectable Non-Small Cell Lung Cancer

Обзор

This study will enroll adult participants with early-stage (stage II-IIIB) non-small cell lung cancer for whom surgery is planned. The aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. The study is also looking at several other research questions, including: * What are the side effects associated with the investigational treatments in comparison to the control treatment? * Do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? * How much of the study drug(s) are in the blood at a given time? * Does the body make antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)?

Вмешательства

• Препарат Cemiplimab
  Intravenous (IV) infusion administration
• Препарат Platinum-based chemotherapy
  IV infusion
• Препарат REGN7075
  IV infusion

Первичные конечные точки

• Major pathologic response (MPR) rate as determined by central blinded independent pathology review (BIPR) [Срок оценки: Up to 12 weeks]

Вторичные конечные точки (12)

• Pathologic complete response (pCR) rate as determined by central BIPR [Срок оценки: Up to 12 weeks]
• Residual viable tumor (RVT) as determined by central BIPR [Срок оценки: Up to 12 weeks]
• Median event-free survival (EFS) [Срок оценки: Up to 5 years]
• EFS rate [Срок оценки: Up to 5 years]
• Objective response rate (ORR) [Срок оценки: Up to 9 weeks]
• Overall survival (OS) [Срок оценки: Up to 5 years]
• Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: Up to 76 weeks]
• Severity of TEAEs [Срок оценки: Up to 76 weeks]
• Incidence of TEAEs leading to death [Срок оценки: Up to 76 weeks]
• Incidence of TEAEs leading to treatment discontinuation [Срок оценки: Up to 76 weeks]
• Incidence of serious adverse events (SAEs) [Срок оценки: Up to 76 weeks]
• Incidence of adverse events of special interest (AESIs) [Срок оценки: Up to 76 weeks]

Критерии участия

General Key Inclusion Criteria:

• Histologically confirmed stage II through IIIB (N2) NSCLC, that is considered resectable with curative intent, as described in the protocol
• Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
• Available formalin-fixed paraffin-embedded (FFPE) tumor sample blocks for submission, as described in the protocol
• Eastern Cooperative Oncology Group Performance Status scale (ECOG PS) of 0 to 1
• Adequate organ and bone marrow function, as described in the protocol

General Key Exclusion Criteria:

• Any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol
• Presence of known oncogenic alterations in epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) in the tumor prior to randomization, as described in the protocol
• Presence of grade≥ 2 peripheral neuropathy
• Another malignancy that is progressing or requires active treatment, as described in the protocol

Arm Specific Exclusion Criteria:

Arm 1:

• Grade ≥3 hypercalcemia, as defined in the protocol
• Any central nervous system (CNS) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (ICANS), as described in the protocol
• Has marked baseline prolongation of the time from the start of the Q wave to the end of the T wave in electrocardiogram (QT)/corrected QT interval (QTc) interval or risk factors for prolonged QTc, as described in the protocol

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

Открытое

Основная цель

Лечение

Центры проведения

США · 15 центров

• University of California Irvine — Orange
• Orchard Healthcare Research Inc. — Skokie
• Karmanos Cancer Institute — Detroit
• Detroit Clinical Research Center — Farmington Hills
• Morristown Medical Center — Morristown
• Rutgers Cancer Institute of New Jersey — New Brunswick
• Oncology Hematology Care Clinical Trials LLC — Cincinnati
• Providence Portland Medical Center — Portland
• … и ещё 7 центров

Испания · 12 центров

• Catalan Instituye of Oncology Badalona — Badalona
• Hospital Valdecilla — Santander
• Hospital Universitario Insular de Gran Canaria — Las Palmas de Gran Canaria
• Clinica Universidad de Navarra — Pamplona
• MD Anderson Cancer Center — Madrid
• Hospital Universitario Clinico San Carlos — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario HM Sanchinarro — Madrid
• … и ещё 4 центра

Бразилия · 11 центров

• Oncology Clinical Research Center — Cachoeiro de Itapemirim
• Instituto Mario Penna — Belo Horizonte
• Instituto Sul Mineiro De Oncologia LTDA — Pouso Alegre
• Instituto de Medicina Integral Professor Fernando Figueira — Recife
• Liga Norte Riograndense Contra o Cancer — Natal
• Hospital Mae de Deus Integrated Oncology Center — Porto Alegre
• Hospital Sao Lucas da PUCRS — Porto Alegre
• Ynova Pesquisa Clinica — Florianópolis
• … и ещё 3 центра

Франция · 7 центров

• CHU Rennes — Rennes
• Centre Hospitalier Intercommunal Toulon - CHITS — Toulon
• Centre Hospitalier de la Cote Basque — Bayonne
• Clinique Belharra — Bayonne
• CHU Grenoble Alpes — Grenoble
• Montpellier Academic Hospital — Montpellier
• Institut Curie — Paris

Германия · 4 центра

• Klinikum Kassel GmbH, Hauttumorzentrum — Kassel
• University Medicine Gottingen — Göttingen
• University of Leipzig — Leipzig
• University Hospital RWTH Aachen — Aachen

Turkey (Türkiye) · 1 центр

• Florya Medical Park Hospital — Istanbul

Идентификаторы

NCT: NCT06465329 · R2810-ONC-2268 · 2023-509806-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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