Lung Cancer Clinical Trial
A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations
Summary
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.
Full Description
Lucitanib is an oral inhibitor of the tyrosine kinase activity of FGFR 1-3, VEGFR 1-3, and PDGFR α/β. Lucitanib has demonstrated potent anti-tumor and anti-angiogenic activity in vitro proliferation assays and in vivo using human tumor xenograft models, with a trend for stronger efficacy in those with genomic aberrancies of FGF or PDGF. Abnormalities in the FGF, VEGF, and PDGF-related genes are observed across lung cancer histologies.
The first in human trial of lucitanib demonstrated that daily lucitanib is clinically active in patients with advanced solid tumors. Specifically, patients with FGFR1-amplification appeared to derive particular benefit from lucitanib.
Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in lung cancer patients with FGF, VEGF, and PDGF genetic alterations.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
Any of the following tumor tissue based genetic alterations: FGFR1, FGFR2, FGFR3, VEGFA, or PDGFRα amplification; Any FGFR1, FGFR2, or FGFR3 gene fusion; FGFR1, FGFR2, or FGFR3 activating mutation
Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Measurable disease per RECIST 1.1
Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Exclusion Criteria:
Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
Symptomatic and/or untreated central nervous system metastases
Presence of another active cancer
Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
Pregnant or breastfeeding women
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There are 19 Locations for this study
Los Angeles California, 90095, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Atlanta Georgia, 30322, United States
Rockville Maryland, 20850, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37203, United States
Caen , 14033, France
Lille , 59037, France
Marseille , 13915, France
Villejuif , 94805, France
Essen , 45147, Germany
Grosshansdorf , 22927, Germany
Oldenburg , 26121, Germany
Milano , 20132, Italy
Milano , 20133, Italy
Orbassano , 10043, Italy
Perugia , 06156, Italy
Barcelona Cataluña, 8035, Spain
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