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

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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 stage IV non-squamous NSCLC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tracon Pharmaceuticals Inc.
• Collaborator: University of Alabama at Birmingham
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Bevacizumab; Carboplatin; Paclitaxel

Criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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.