Trial · NCT03780010
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
NCT03780010, Phase 1, Completed, Tracon Pharmaceuticals Inc.; results first posted 2019-10-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC. Trials, record NCT03780010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03780010
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
- NCT number
- NCT03780010
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- TRC105
- First posted
- 2018-12-19
- Last updated
- 2019-10-28
- Results first posted
- 2019-10-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-Emergent Adverse Events | from screening until completion of follow-up, on average 6 months | Incidence of treatment-emergent (i.e. TRC105, bevacizumab, paclitaxel and/or carboplatin) adverse events by CTCAE v4.03 |
| Secondary | Overall RECIST 1.1 Response Rate | 6 months | Response rate determined according to RECIST 1.1 criteria |
| Secondary | Percent of Patients With Progression-free Survival (PFS) at 6 Months | 6 months | Number of patients with progression-free survival at 6 months determined according to RECIST 1.1 criteria |
| Secondary | Median Progression Free Survival | months | Median duration of progression free survival according to RECIST 1.1 criteria |
| Secondary | Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin | 3 months | Trough serum TRC105 pharmacokinetic concentrations at steady state (cycle 3 day 1) will be measured using validated ELISA methods. |
| Secondary | Number of Patients Who Have TRC105 Positive Anti-Product Antibodies | 6 months | Anti-product antibody concentrations will be measured using validated ELISA methods. Anti-product antibody concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment-Emergent Adverse Events | from screening until completion of follow-up, on average 6 months | All patients who received at least a portion of a dose of any study drug (TRC105, Bevacizumab or Paclitaxel/Carboplatin) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall RECIST 1.1 Response Rate | 6 months | Number of patients with a baseline scan and at least 1 on study scan were evaluable for response rate determination | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent of Patients With Progression-free Survival (PFS) at 6 Months | 6 months | Number of patients progression free according to RECIST 1.1 after 6 months of treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Progression Free Survival | months | Number of patients progression free according to RECIST 1.1 after 6 months of treatment | Months | MEDIAN |
| SECONDARY | Pharmacokinetic Profile of TRC105 When Given With Bevacizumab and Paclitaxel/Carboplatin | 3 months | All patients who received at least a portion of a dose of TRC105 with PK samples collected at baseline and at least 1 time point on study | ng/mL | MEAN |
| SECONDARY | Number of Patients Who Have TRC105 Positive Anti-Product Antibodies | 6 months | All patients who received at least a portion of a dose of TRC105 with immunogenicity samples collected at baseline and at least 1 time point on study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-Emergent Adverse Events | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced an AE | 3 | Participants | |
| Treatment-Emergent Adverse Events | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced an AE | 12 | Participants | |
| Treatment-Emergent Adverse Events | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a TRC105 related AE | 3 | Participants | |
| Treatment-Emergent Adverse Events | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a TRC105 related AE | 11 | Participants | |
| Treatment-Emergent Adverse Events | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a Bev related AE | 3 | Participants | |
| Treatment-Emergent Adverse Events | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a Bev related AE | 10 | Participants | |
| Treatment-Emergent Adverse Events | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a Carbo related AE | 3 | Participants | |
| Treatment-Emergent Adverse Events | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a Carbo related AE | 12 | Participants | |
| Treatment-Emergent Adverse Events | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a Pac related AE | 3 | Participants | |
| Treatment-Emergent Adverse Events | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | Participants who experienced a Pac related AE | 12 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 3 | |
| Overall Study | STARTED | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 12 | |
| Overall Study | COMPLETED | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 3 | |
| Overall Study | COMPLETED | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 12 | |
| Overall Study | NOT COMPLETED | 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 0 | |
| Overall Study | NOT COMPLETED | 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin | 0 |
Source ClinicalTrials.gov
Adverse events2,695
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 15 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 1 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 1 | 12 | 1 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 6 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 9 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 | 0 |
| other | Abdominal Cramps | Gastrointestinal disorders | TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 2 | 0 |
1 to 10 of 2,695Source ClinicalTrials.gov
See all 2,695 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TRC105 (0.00-0.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 1 | 15 |
| Total, all-cause mortality | TRC105 (1.00-1.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 1 |
| Total, all-cause mortality | TRC105 (2.00-2.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 12 |
| Total, all-cause mortality | TRC105 (3.0-3.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 |
| Total, all-cause mortality | TRC105 (4.0-4.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 6 |
| Total, all-cause mortality | TRC105 (5.0-5.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 9 |
| Total, all-cause mortality | TRC105 (6.00-6.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 |
| Total, all-cause mortality | TRC105 (7.00-7.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 |
| Total, all-cause mortality | TRC105 (8.00-8.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 5 |
| Total, all-cause mortality | TRC105 (9.00-9.99 mg/kg)+Bevacizumab+Paclitaxel/Carboplatin | 0 | 2 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| 8 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin vs 10 mg/kg TRC105 + Bevacizumab + Paclitaxel/Carboplatin: Percent of Patients With Progression-free Survival (PFS) at 6 Months |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03780010
GET https://conductscience.org/api/trials/v1/NCT03780010/results?page=2