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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lucitanib | Experimental | Lucitanib given orally once daily on a continuous schedule. Starting dose is 10 mg/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucitanib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Screening, every 8 weeks; up to 2 years |
| Progression-Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35844029 | Derived | 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. |
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|
Time from the date of first drug intake until the date of progression or death for any cause |
| Screening, every 8 weeks; up to 2 years |
| 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 | Screening, every 8 weeks; up to 2 years |
| 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 | Screening, every 8 weeks; up to 2 years |
| Overall Survival (OS) | From the date of first drug intake to the date of death for any cause | Continuously; up to 2 years |
| Tumor growth kinetics | Will be evaluated using the following criteria: tumor size; tumor volume; tumor growth | Screening, every 8 weeks; up to 2 years |
| Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications | Continuously; up to 2 years |
| PK parameters of lucitanib | Cycle 1 Day 14 and 28, Cycle 2 Day 28, Cycle 3 Day 28 |
| Pharmacogenomic analysis of inter-patients variation in gene encoding ADME involved proteins | Cycle 1 Day 1 |
| Pharmacodynamic (PD) evaluation of lucitanib profile | Soluble growth factors and other biomarkers, including circulating tumor DNA | Cycle 1 Day 1 and 14, End of Study |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Associates in Oncology and Hematology | Rockville | Maryland | 20850 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| CHU Caen, Hôpital de la Côte de Nacre | Caen | 14033 | France |
| CHRU Lille, Hôpital Albert Calmette | Lille | 59037 | France |
| Hôpital Nord | Marseille | 13915 | France |
| Institut Gustave-Roussy | Villejuif | 94805 | France |
| Universität Duisburg-Essen | Essen | 45147 | Germany |
| Hospital Grosshansdorf | Großhansdorf | 22927 | Germany |
| Pius Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Fondazione IRCCS Istituto Nazionale Tumori | Milan | 20133 | Italy |
| AOU San Luigi Gonzaga | Orbassano | 10043 | Italy |
| Ospedale S. Maria della Misericordia | Perugia | 06156 | Italy |
| Hospital Universitari Vall d'Hebrón | Barcelona | Catalonia | 8035 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000595232 | E-3810 |
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