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Terminated

Phase 2
Age: 18Years +
All Genders
ID02109016

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 AdvancedMetastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

Led by Clovis Oncology, Inc. · Updated on 2019-07-29

18

Participants Needed

19

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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