AzTrials
AzTrials

Non-Small Cell Lung CancerPhase 2NCT02109016

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

A Phase 2 study testing Lucitanib in people with Non-Small Cell Lung Cancer and Squamous Non-Small Cell Lung Cancer, run by Clovis Oncology, Inc. at 19 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lucitanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
19 sitesin 5 countries
Study dates
Apr 2014to Sep 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 5 countries.

19 sites in 5 countries

United States7 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Associates in Oncology and Hematology

    Rockville, Maryland, 20850

  • Georgetown University

    Washington D.C., District of Columbia, 20007

Other trials in United States

France4 sites

  • CHU Caen, Hôpital de la Côte de Nacre

    Caen, 14033

  • CHRU Lille, Hôpital Albert Calmette

    Lille, 59037

  • Hôpital Nord

    Marseille, 13915

  • Institut Gustave-Roussy

    Villejuif, 94805

Other trials in France

Italy4 sites

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, 20133

  • AOU San Luigi Gonzaga

    Orbassano, 10043

  • Ospedale S. Maria della Misericordia

    Perugia, 06156

Other trials in Italy

Germany3 sites

  • Universität Duisburg-Essen

    Essen, 45147

  • Hospital Grosshansdorf

    Großhansdorf, 22927

  • Pius Hospital Oldenburg

    Oldenburg, 26121

Other trials in Germany

Spain1 site

  • Hospital Universitari Vall d'Hebrón

    Barcelona, Catalonia, 8035

Other trials in Spain

About this study

Official title: A Single Arm, Open-label, Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent 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.

Read the detailed 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.

Being tested
Lucitanib
Keywords
FGFR1 amplification, FGF alteration, VEGF alteration, PDGF alteration, Tyrosine kinase inhibitor, VEGFR inhibitor, FGFR inhibitor, PDGFR inhibitor, VEGFR-FGFR inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02109016
Study groupRoleWhat they receive
LucitanibExperimentalLucitanib given orally once daily on a continuous schedule. Starting dose is 10 mg/day.
Receives: Drug: Lucitanib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Screening, every 8 weeks; up to 2 years

Secondary outcomes (10)

  1. Clinical Benefit Rate (CBR)

    Proportion of patients in whom a confirmed CR or confirmed PR or a prolonged Stable Disease (SD) (≥ 6 months), as best overall response according to RECIST, is observed

    Measured: Screening, every 8 weeks; up to 2 years

  2. Progression-Free Survival (PFS)

    Time from the date of first drug intake until the date of progression or death for any cause

    Measured: Screening, every 8 weeks; up to 2 years

  3. Duration of response (DOR)

    For responders (i.e. patients with best overall response CR or PR), the interval from the time of first documentation of response to the date of progression or death for any cause

    Measured: Screening, every 8 weeks; up to 2 years

  4. Duration of clinical benefit

    For responders and patients with SD as best overall response, time from the first drug intake until the date of progression or death for any cause

    Measured: Screening, every 8 weeks; up to 2 years

  5. Overall Survival (OS)

    From the date of first drug intake to the date of death for any cause

    Measured: Continuously; up to 2 years

  6. Tumor growth kinetics

    Will be evaluated using the following criteria: tumor size; tumor volume; tumor growth

    Measured: Screening, every 8 weeks; up to 2 years

  7. Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications

    Measured: Continuously; up to 2 years

  8. PK parameters of lucitanib

    Measured: Cycle 1 Day 14 and 28, Cycle 2 Day 28, Cycle 3 Day 28

  9. Pharmacogenomic analysis of inter-patients variation in gene encoding ADME involved proteins

    Measured: Cycle 1 Day 1

  10. Pharmacodynamic (PD) evaluation of lucitanib profile

    Soluble growth factors and other biomarkers, including circulating tumor DNA

    Measured: Cycle 1 Day 1 and 14, End of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completion1 Apr 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02109016
Sponsor's protocol ID
E-3810-II-02
Status last verified
Jul 2019
First submitted
7 Apr 2014
Last updated
29 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35844029

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lucitanib in people with Non-Small Cell Lung Cancer and Squamous Non-Small Cell Lung Cancer, run by Clovis Oncology, Inc. at 19 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, France, Italy, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Screening, every 8 weeks; up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02109016, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in