drugset / Trial / NCT03762122

Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC)

NCT03762122

Phase 2 Terminated 15 enrolled Swiss Cancer Institute
NaSingle-groupOpen-labelTreatment

Summary

A recent investigation showed that a substantial proportion of patients with SQCLC (46%) exhibit tumor overexpression of fibroblast growth factor receptor (FGFR) messenger ribonucleic acid (mRNA) and are potentially sensitive to FGFR-targeting treatment. Rogaratinib is a novel pan-FGFR inhibitor which showed strong anti-tumor efficacy in pre-clinical models as a single agent in FGFR pathway-addicted tumor models. SQCLC patients overexpressing tumor FGFR mRNA, who will be included into this clinical trial, do not have currently any alternative systemic treatment with a proven and clinically reasonable benefit. The objective of the trial is to determine clinical activity and safety of rogaratinib in patients with advanced SQCLC overexpressing tumor FGFR1-3 mRNA.

Timeline

Start
2019-07-25
Primary completion
2021-08-13
Completion
2021-08-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Rogaratinib Small molecule 600 mg Oral
Subject Rogaratinib Small molecule 800 mg Oral