Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 24
Summary
- Conditions
- Squamous Cell Non-small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a single-arm, multicenter phase II clinical trial. The trial uses a single-stage design based on a time-to-event rate to a specific time-point using Kaplan-Meier estimators. Rogaratinib is given at a dose of 800 mg twice daily in continuous 28-days cycles, without treatment breaks (except for toxicity management). Trial treatment is continued until evidence of tumor progression, unacceptable toxicity, consent withdrawal or withdrawal by the investigator. In order to include 24 patients into the trial, it is expected that 52 patients with advanced SQCLC have to be screened for tumor FGFR mRNA overexpression. Taking into account patients who are FGFR mRNA positive but cannot be enrolled (attrition rate of 20%), it is estimated that 68 patients will have to be screened in total.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Squamous-cell lung cancer (SQCLC) is a distinct histologic subtype of non-small cell lung cancer (NSCLC) that is challenging to treat because of specific clinicopathologic characteristics (older age, advanced disease at diagnosis, central location of tumors) and the absence of molecular alterations,...
Squamous-cell lung cancer (SQCLC) is a distinct histologic subtype of non-small cell lung cancer (NSCLC) that is challenging to treat because of specific clinicopathologic characteristics (older age, advanced disease at diagnosis, central location of tumors) and the absence of molecular alterations, which can be successfully treated with targeted therapy. 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. The clinical experience with rogaratinib comes from two ongoing phase I trials enrolling patients with refractory, locally advanced or metastatic solid tumors who were selected based on tumoral overexpression of FGFR mRNA. Such selection identifies patients with high FGFR tumor target levels due to DNA aberrations in FGFR-encoding genes and due to non-genetic and epigenetic regulation of FGFR expression (incl. promoter activation). To date, rogaratinib has shown to be well tolerated (no dose-limiting toxicity) with promising clinical activity, in particular in bladder cancer. Despite the constant improvement in the treatment of patients with advanced lung cancer, there is still a high-unmet medical need to develop new and highly active anticancer drugs for patients who have failed standard systemic treatment, and have an otherwise very unfavorable prognosis. 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.
Tracking Information
- NCT #
- NCT03762122
- Collaborators
- Not Provided
- Investigators
- Study Chair: Alfredo Addeo, MD University Hospital, Geneva
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