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
National Cancer Institute (NCI)
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.
Description
PRIMARY OBJECTIVE: I. To improve progression-free survival (PFS) from 56% with current standard of care (chemoradiation followed by consolidative durvalumab) to 75% at one year with the proposed combination followed by consolidative durvalumab. SECONDARY OBJECTIVES: I. To determine overall survival with the proposed combination therapy. II. To assess the incidence of grade 3 or higher pneumonitis and other toxicities. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive methoxyamine orally (PO) on day 1 of each cycle, pemetrexed intravenously (IV) over 10 minutes on da…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically or cytologically confirmed adenocarcinoma or large cell carcinoma of the lung with confirmation by immunohistochemistry (histologic tissue diagnosis is preferred, but cytology is acceptable). * Patients must have newly staged IIIA, IIIB or IIIC disease according to the 8th tumor, node, metastasis (TNM) staging classification and to be considered appropriate candidates for aggressive chemoradiotherapy. * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest…
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
Locations (34)
- Keck Medicine of USC Buena ParkBuena Park, California
- City of Hope Comprehensive Cancer CenterDuarte, California
- City of Hope at Irvine LennarIrvine, California
- City of Hope Antelope ValleyLancaster, California
- Los Angeles General Medical CenterLos Angeles, California
- USC / Norris Comprehensive Cancer CenterLos Angeles, California