Recruitment

Recruitment Status
Terminated
Estimated Enrollment
40

Inclusion Criteria

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
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
Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
Measurable disease per RECIST 1.1
Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria

Pregnant or breastfeeding women
Symptomatic and/or untreated central nervous system metastases
Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
...
Pregnant or breastfeeding women
Symptomatic and/or untreated central nervous system metastases
Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive 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
Presence of another active cancer

Summary

Conditions
  • Lung Cancer
  • Advanced 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
  • Non-small Cell Lung Cancer
  • Squamous Non-Small Cell 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 Criteria

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
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
Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
Measurable disease per RECIST 1.1
Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion Criteria

Pregnant or breastfeeding women
Symptomatic and/or untreated central nervous system metastases
Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
...
Pregnant or breastfeeding women
Symptomatic and/or untreated central nervous system metastases
Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive 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
Presence of another active cancer

Tracking Information

NCT #
NCT02109016
Collaborators
Not Provided
Investigators
Not Provided