Last updated 12 days ago
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)
120 patients around the world
Available in United States, Brazil
Regeneron Pharmaceuticals
3Research sites
120Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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 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.
Sites
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recruiting
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
SponsorRegeneron Pharmaceuticals
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06465329
