Letzte Aktualisierung: 06.05.2026
Lungenkarzinom [C34]
RELATIVITY
Studieninformationen
CA224-1093 - Eine randomisierte, offene Phase-3-Studie zur Festdosiskombination (FDK) von Nivolumab + Relatlimab mit Chemotherapie im Vergleich zu Pembrolizumab mit Chemotherapie als Erstlinienbehandlung für Teilnehmer mit einem nicht-plattenepithelialem (NSQ), Stadium-IV- oder rezidiviertem nicht-kleinzelligem Lungenkarzinom und mit einer PD-L1-Expression der Tumorzellen von ≥ 1 %
Ziele
Primäres Prüfziel
Overall survival (OS) in randomized participants with PD-L1 1% to 49%
Sekundäre Prüfziele für die Behandlungsarme:
OS in randomized participants with PD-L1 ≥ 1% Progression-free survival (PFS) as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR) Overall response rate (ORR)
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
nicht-plattenepitheliales (NSQ), Stadium-IV- oder rezidiviertes nicht-kleinzelligem Lungenkarzinom und mit einer PD-L1- Expression der Tumorzellen von ≥ 1 %
Mutation
Patienten
Alter
Einschlusskriterien
AUSWAHL: Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease. Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization. Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. Participants must have a life expectancy of at least 3 months at the time of randomization.
Ausschlusskriterien
AUSWAHL: Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded. Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible. Participants must not have untreated central nervous system (CNS) metastases. Participants must not have leptomeningeal metastases (carcinomatous meningitis). Participants must not have concurrent malignancy requiring treatment. Participants must not have an active autoimmune disease. Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management. Participants must not have a history of myocarditis. Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
Therapie
Intervention
Substanz
| Prüfplancode | CA224-1093 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT06561386 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
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Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




