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
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 40
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
- Measurable disease per RECIST 1.1
- ...
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
- Measurable disease per RECIST 1.1
- 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
- Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Exclusion Criteria
- Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
- Presence of another active cancer
- Pregnant or breastfeeding women
- ...
- Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
- Presence of another active cancer
- Pregnant or breastfeeding women
- Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
- Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
- Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
- Symptomatic and/or untreated central nervous system metastases
Summary
- Conditions
- Metastatic Lung Cancer
- Advanced Lung Cancer
- 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
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
- Measurable disease per RECIST 1.1
- ...
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC
- Measurable disease per RECIST 1.1
- 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
- Documented radiographic disease progression following at least one line of therapy in the advanced/metastatic setting
Exclusion Criteria
- Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
- Presence of another active cancer
- Pregnant or breastfeeding women
- ...
- Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher than 5 mIU/mL while receiving appropriate thyroid hormone therapy
- Presence of another active cancer
- Pregnant or breastfeeding women
- Uncontrolled hypertension, defined as SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg with optimized anti-hypertensive therapy
- Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel
- Ongoing adverse events from surgery or prior anti-cancer therapies, including radiation, targeted, or cytotoxic therapies
- Symptomatic and/or untreated central nervous system metastases
Tracking Information
- NCT #
- NCT02109016
- Collaborators
- Not Provided
- Investigators
- Not Provided
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