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NCT05198830 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer
A Phase 2 study of Stage III Lung Cancer AJCC v8 and Lung Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 20
- Study locations
NCT05198830 is a Phase 2 study of Stage III Lung Cancer AJCC v8 and Lung Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 99-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT05198830, a Phase 2 study of Stage III Lung Cancer AJCC v8 and Lung Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-squamous non-small cell lung cancer (NSCLC). TRC102 is in a class of drugs called antineoplastic agents. It blocks the ability of a cell to repair damage to its deoxyribonucleic acid (DNA) and may kill tumor cells. It may also help some anticancer drugs work better. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving TRC102 in combination with usual care treatment may be more effective than usual care treatment alone in stabilizing and lengthening survival time in patients with stage III non-squamous NSCLC.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- BIOLOGICAL Durvalumab
- PROCEDURE FDG-Positron Emission Tomography
Study Locations (20)
California
- Keck Medicine of USC Buena Park - Buena Park
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope at Irvine Lennar - Irvine
- City of Hope Antelope Valley - Lancaster
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- University of California Davis Comprehensive Cancer Center - Sacramento
- City of Hope South Pasadena - South Pasadena
- City of Hope Upland - Upland
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UF Health Cancer Institute - Gainesville - Gainesville
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
- UC Comprehensive Cancer Center at Silver Cross - New Lenox
- University of Chicago Medicine-Orland Park - Orland Park
Indiana
- UChicago Medicine Northwest Indiana - Crown Point
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-12-15 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05198830
The ClinicalTrials.gov registry entry for NCT05198830 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (58% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stage III Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05198830 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT05198830 about?
NCT05198830 is a clinical study titled "Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer". This phase II trial tests whether TRC102 (methoxyamine hydrochloride) in combination usual care treatment comprised of pemetrexed, cisplatin or carboplatin, and radiation therapy followed by durvalumab works better than the usual care treatment alone to shrink tumors in patients with stage III non-s...
What is the current status of trial NCT05198830?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2022-12-15. Estimated completion is 2027-06-30.
What conditions does trial NCT05198830 study?
This clinical trial studies the following conditions: Stage III Lung Cancer AJCC v8, Lung Adenocarcinoma, Lung Non-Squamous Non-Small Cell Carcinoma, Lung Large Cell Carcinoma.
What interventions are being tested in trial NCT05198830?
The interventions under investigation include: Carboplatin (DRUG), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Durvalumab (BIOLOGICAL), FDG-Positron Emission Tomography (PROCEDURE).
Who is sponsoring clinical trial NCT05198830?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05198830 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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