Status:

COMPLETED

Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC

Lead Sponsor:

Tracon Pharmaceuticals Inc.

Collaborating Sponsors:

University of Alabama at Birmingham

Conditions:

Non Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This is a single center, open-label, nonrandomized, phase 1b, dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with sta...

Detailed Description

Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in non-squamous non-small cell lung cancer (NSCLC) patients when given...

Eligibility Criteria

Inclusion

  • Key
  • Stage 4 Non-Squamous Cell Lung Cancer that has not been treated previously with systemic chemotherapy or bevacizumab, but may have received prior targeted treatment (e.g., alk1 inhibitor)
  • ECOG performance status ≤ 1
  • Measurable disease by RECIST
  • Key

Exclusion

  • Non-small cell lung cancer of squamous histology
  • Current treatment on another therapeutic clinical trial
  • Patients who have received wide field radiotherapy ≤ 28 days (defined as \> 50% of volume of pelvic bones or equivalent) or limited field radiation for palliation \< 14 days prior to study registration or those patients who have not recovered adequately from side effects of such therapy
  • Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible.

Key Trial Info

Start Date :

September 1 2015

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2019

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT03780010

Start Date

September 1 2015

End Date

June 1 2019

Last Update

October 28 2019

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