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Clinical trial details
An Open-label, Phase I, Dose Escalation, Expansion Study of MGY825 in Adult Patients With Advanced Non-small Cell Lung Cancer
Identifier
CMGY825A12101
Sponsor
NOVARTIS FARMACÉUTICA, S.A.
Principal Investigator
ENRIQUETA FELIP FONT
Service
Oncology
Study details
Tumor type: LUNG-SCLC
Stage: Advanced
Main Investigational Agent : Targeted therapy
Phase: I
Randomization: Non-randomized
Molecular details
Biomarker: CUL3 alt; KEAP1 alt; NFE2L2 alt
Biomarker criteria: Mandatory
Prescreening: Local
Additional study population requirements: Dose escalation and dose expansion group 1:
Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NFE2L2/KEAP1/CUL3 mutant NSCLC. Local data confirming the NFE2L2/KEAP1/CUL3 mutation status in tissue must be available for enrollment.
Dose expansion group 2:
Patients with histologically or cytologically confirmed diagnosis of advanced (metastatic or unresectable) NSCLC irrespective of NFE2L2/KEAP1/CUL3 mutation status.
