Recruitment

Recruitment Status
Terminated
Estimated Enrollment
40

Inclusion Criterias

Measurable disease per RECIST 1.1
Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
Eastern Cooperative Oncology Group (ECOG) of 0 or 1
...
Measurable disease per RECIST 1.1
Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
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

Exclusion Criterias

Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
...
Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
Symptomatic and/or untreated central nervous system metastases
Presence of another active cancer
Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
Pregnant or breastfeeding women

Summary

Conditions
  • Advanced Lung Cancer
  • Lung Cancer
  • Metastatic Lung Cancer
  • Non-small Cell Lung Cancer
  • NSCLC
  • SCLC
  • Small Cell Lung Cancer
  • Squamous Non-Small Cell Lung Cancer
  • Stage IV Lung Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 wi...

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.

Inclusion Criterias

Measurable disease per RECIST 1.1
Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
Eastern Cooperative Oncology Group (ECOG) of 0 or 1
...
Measurable disease per RECIST 1.1
Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Availability of tumor tissue sample suitable for the central confirmation of the genetic alteration and exploratory analyses
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

Exclusion Criterias

Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
...
Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
Symptomatic and/or untreated central nervous system metastases
Presence of another active cancer
Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
Pregnant or breastfeeding women

Locations

Milano, 20133
Oldenburg, 26121
Essen, 45147
Nashville, Tennessee, 37203
Barcelona, Cataluña, 8035
...
Milano, 20133
Oldenburg, 26121
Essen, 45147
Nashville, Tennessee, 37203
Barcelona, Cataluña, 8035
Villejuif, 94805
Atlanta, Georgia, 30322
Washington, District of Columbia, 20007
Caen, 14033
Rockville, Maryland, 20850
Marseille, 13915
Aurora, Colorado, 80045
Orbassano, 10043
Los Angeles, California, 90095
Pittsburgh, Pennsylvania, 15232
Lille, 59037
Milano, 20132
Perugia, 06156
Grosshansdorf, 22927

Tracking Information

NCT #
NCT02109016
Collaborators
Not Provided
Investigators
Not Provided