RecruitingPhase 2NCT05198830

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 Randomized Study of the BER Inhibitor TRC102 in Combination With Standard Pemetrexed-Platinum-Radiation in Stage III Non-Squamous Non-Small Cell Lung Cancer


Sponsor

National Cancer Institute (NCI)

Enrollment

42 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new drug called TRC102 to standard chemotherapy (pemetrexed with cisplatin or carboplatin) during radiation therapy improves outcomes for people with stage III non-squamous non-small cell lung cancer. **You may be eligible if...** - You have been diagnosed with stage IIIA, IIIB, or IIIC non-small cell lung cancer (specifically adenocarcinoma or large cell type) - Your lung cancer has not spread to distant organs - Your cancer has not been previously treated - You are in good physical health (able to care for yourself and carry out light activity) - Your kidneys, liver, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have a history of severe lung disease or prior chest radiation - You have active autoimmune disease - Your squamous cell lung cancer type (only non-squamous types are eligible) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin

Given IV

DRUGCisplatin

Given IV

PROCEDUREComputed Tomography

Undergo CT and FDG-PET/CT

BIOLOGICALDurvalumab

Given IV

PROCEDUREFDG-Positron Emission Tomography

Undergo FDG-PET/CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGMethoxyamine

Given PO

DRUGPemetrexed

Given IV

RADIATIONRadiation Therapy

Undergo thoracic radiation


Locations(34)

Keck Medicine of USC Buena Park

Buena Park, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

City of Hope Upland

Upland, California, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States

Jersey City Medical Center

Jersey City, New Jersey, United States

Saint Barnabas Medical Center

Livingston, New Jersey, United States

Monmouth Medical Center

Long Branch, New Jersey, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Community Medical Center

Toms River, New Jersey, United States

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

University of Texas Medical Branch

Galveston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05198830


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