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
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.
Checked against the public recordLast updated Jul 29, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Clovis Oncology, Inc.
- Interventions being studied
- Drug: Lucitanib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California, Los AngelesLos Angeles, California
- University of ColoradoAurora, Colorado
- Georgetown UniversityWashington D.C., District of Columbia
- Emory UniversityAtlanta, Georgia
- Associates in Oncology and HematologyRockville, Maryland
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Tennessee OncologyNashville, Tennessee
- CHU Caen, Hôpital de la Côte de NacreCaen
- CHRU Lille, Hôpital Albert CalmetteLille
- Hôpital NordMarseille
- Institut Gustave-RoussyVillejuif
- Universität Duisburg-EssenEssen
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 29, 2019. Always confirm current availability with the study team.