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

Study 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.

Ask AI to explain this study

Start here

Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedLucitanib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Small cell lung cancer (SCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 29, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?19 U.S. locations

Locations may change over time.

Who runs it?Clovis Oncology, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Clovis Oncology, Inc.
Interventions being studied: Drug: Lucitanib

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→Small cell lung cancer (SCLC)→

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

View original record ↗