NCT02109016

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_2 nonsmall-cell-lung-cancer

Geographic Reach
5 countries

19 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

April 7, 2014

Last Update Submit

July 22, 2019

Conditions

Non-Small Cell Lung CancerSquamous Non-Small Cell Lung CancerNSCLCSmall Cell Lung CancerSCLCLung CancerAdvanced Lung CancerMetastatic Lung CancerStage IV Lung Cancer

Keywords

FGFR1 amplificationFGF alterationVEGF alterationPDGF alterationTyrosine kinase inhibitorVEGFR inhibitorFGFR inhibitorPDGFR inhibitorVEGFR-FGFR inhibitor

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate (ORR)

    Proportion of patients in whom a confirmed Complete Response (CR) or a confirmed Partial Response (PR), as best overall response according to RECIST criteria, is observed.

    Screening, every 8 weeks; up to 2 years

Secondary Outcomes (10)

  • Clinical Benefit Rate (CBR)

    Screening, every 8 weeks; up to 2 years

  • Progression-Free Survival (PFS)

    Screening, every 8 weeks; up to 2 years

  • Duration of response (DOR)

    Screening, every 8 weeks; up to 2 years

  • Duration of clinical benefit

    Screening, every 8 weeks; up to 2 years

  • Overall Survival (OS)

    Continuously; up to 2 years

  • +5 more secondary outcomes

Study Arms (1)

Lucitanib

EXPERIMENTAL

Lucitanib given orally once daily on a continuous schedule. Starting dose is 10 mg/day.

Drug: Lucitanib

Interventions

LucitanibDRUG

Lucitanib given orally to all patients, once daily (q.d.), on a continuous schedule over 28-day cycles, in fasting conditions (at least 2 hours prior to and 2 hours after any meal), until progressive disease or unacceptable toxicity. Starting dose is 10 mg/day and can be reduced in 2.5 mg decrements to 5 mg/day based on individual tolerability.

Lucitanib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Associates in Oncology and Hematology

Rockville, Maryland, 20850, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

CHU Caen, Hôpital de la Côte de Nacre

Caen, 14033, France

Location

CHRU Lille, Hôpital Albert Calmette

Lille, 59037, France

Location

Hôpital Nord

Marseille, 13915, France

Location

Institut Gustave-Roussy

Villejuif, 94805, France

Location

Universität Duisburg-Essen

Essen, 45147, Germany

Location

Hospital Grosshansdorf

Großhansdorf, 22927, Germany

Location

Pius Hospital Oldenburg

Oldenburg, 26121, Germany

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

AOU San Luigi Gonzaga

Orbassano, 10043, Italy

Location

Ospedale S. Maria della Misericordia

Perugia, 06156, Italy

Location

Hospital Universitari Vall d'Hebrón

Barcelona, Catalonia, 8035, Spain

Location

Related Publications (1)

  • Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18.

    PMID: 35844029DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaLung Neoplasms

Interventions

E-3810

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2016

Study Completion

September 1, 2016

Last Updated

July 29, 2019

Record last verified: 2019-07

Locations

IT(4)DE(3)FR(4)ES(1)US(7)