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

Stopped early · Phase 2

Conditions studied: Non-Small Cell Lung Cancer, Squamous Non-Small Cell Lung Cancer, NSCLC, Small Cell Lung Cancer, SCLC, Lung Cancer, Advanced Lung Cancer, Metastatic Lung Cancer, Stage IV Lung Cancer

In brief

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.

Key facts

Study ID

NCT02109016

Run by

Clovis Oncology, Inc.

People needed

18

Starts

2014-04-01

Expected to finish

2016-09-01

Last updated by the study team

2019-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• University of Colorado — Aurora, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Associates in Oncology and Hematology — Rockville, Maryland, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• CHU Caen, Hôpital de la Côte de Nacre — Caen, France
• CHRU Lille, Hôpital Albert Calmette — Lille, France
• Hôpital Nord — Marseille, France
• Institut Gustave-Roussy — Villejuif, France
• Universität Duisburg-Essen — Essen, Germany
• Hospital Grosshansdorf — Großhansdorf, Germany
• Pius Hospital Oldenburg — Oldenburg, Germany
• Ospedale San Raffaele — Milan, Italy
• Fondazione IRCCS Istituto Nazionale Tumori — Milan, Italy
• AOU San Luigi Gonzaga — Orbassano, Italy
• Ospedale S. Maria della Misericordia — Perugia, Italy
• Hospital Universitari Vall d'Hebrón — Barcelona, Catalonia, Spain

Full record on ClinicalTrials.gov

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