NCT03780010

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 stage IV non-squamous NSCLC.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 28, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

November 13, 2018

Results QC Date

August 8, 2019

Last Update Submit

October 4, 2019

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment-Emergent Adverse Events

    Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03

    from screening until completion of follow-up, on average 6 months

Secondary Outcomes (5)

  • Overall RECIST 1.1 Response Rate

    6 months

  • Percent of Patients With Progression-free Survival (PFS) at 6 Months

    6 months

  • Median Progression Free Survival

    months

  • Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin

    3 months

  • Number of Patients Who Have TRC105 Positive Anti-Product Antibodies

    6 months

Study Arms (1)

TRC105 + B + P + C

EXPERIMENTAL

TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.

Drug: TRC105

Interventions

TRC105DRUG

Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.

Also known as: Bevacizumab, Paclitaxel, Carboplatin
TRC105 + B + P + C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

carotuximabBevacizumabPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Results Point of Contact

Title
Medical Monitor
Organization
TRACON Pharmaceuticals Inc
clinicaltrials@traconpharma.com
8585500780

Study Officials

  • Charles Theuer, MD

    TRACON Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

December 19, 2018

Study Start

September 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

October 28, 2019

Results First Posted

October 28, 2019

Record last verified: 2019-10