Phase 1
Completed N=15
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
Source: ClinicalTrials.gov NCT03780010 ↗Enrolled (actual)
15
Serious AEs
16.7%
Results posted
Oct 2019
Primary outcomePrimary: Treatment-Emergent Adverse Events — 3; 12; 3; 11 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-Emergent Adverse Events |
3; 12; 3; 11; 3; 10 | — |
| SECONDARY Overall RECIST 1.1 Response Rate |
2; 9; 1; 3; 0; 0 | — |
| SECONDARY Percent of Patients With Progression-free Survival (PFS) at 6 Months |
1; 7 | — |
| SECONDARY Median Progression Free Survival |
3; 6.5 | — |
| SECONDARY Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin |
56600; 103228 | — |
| SECONDARY Number of Patients Who Have TRC105 Positive Anti-Product Antibodies |
0; 1; 3; 10 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03780010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.