A phase II trial to evaluate efficacy and safety of erdafitinib in patients with advanced squamous NSCLC (sqNSCLC) harboring FGFR genetic alterations after relapse of standard therapy.
Cohort 1: Activating (high confidence) FGFR translocations (max. 15 patients)
Cohort 2: Activating (high confidence) hotspot FGFR mutations (max. 15 patients)
Cohort 3: Activating (low confidence) FGFR alteration (max. 20 patients)
The primary objective is to evaluate the efficacy of erdafitinib in sqNSCLC with FGFR genetic alteration.
In- and exclusion Criteria
• Stage IIIB/IV sqNSCLC patients with activating FGFR alteration after failure on standard treatment, or in the opinion of the investigator no effective standard therapy exists, is appropriate, tolerated, or is considered equivalent to study treatment
• Activating FGFR alteration as approved by FIND Molecular Board
• Pathogenic somatic mutations/translocations in the following genes: EGFR, ALK, ROS1, BRAF, K-RAS, N-RAS, PIK3CA, PTEN
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to randomization.
• Treatment with small molecules or chemotherapy within 7 days prior to C1D1
• Treatment with monoclonal antibodies within 28 days prior to C1D1.
This study is an open-label, multicenter, Phase II study to evaluate the safety and efficacy of erdafitinib in subjects with advanced squamous NSCLC (sqNSCLC) harbouring FGFR genetic alterations after relapse of standard therapy. Subjects will be assessed for molecular eligibility during pre-screening in national Network Genomic Medicine (nNGM).
LCGC – University Hospital of Cologne
University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
PD Dr. Lucia Nogova, MSc,
Last Update: 1. February 2019