Clinical Trials Logo

Clinical Trial 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 DNA and may kill cancer 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 cancer cells. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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 cancer 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.


Clinical Trial 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 day 1 of each cycle, and cisplatin IV over 60 minutes or carboplatin IV over 30 minutes on day 3 of each cycle. Beginning day 3, patients also undergo radiation therapy daily Monday-Friday. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after cycle 2, patients receive durvalumab IV over 60 minutes every 2 weeks or monthly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) throughout the trial and positron emission tomography (PET)/CT scan during screening and on study. ARM II: Patients receive pemetrexed IV over 10 minutes and cisplatin IV over 60 minutes or carboplatin IV over 30 minutes on day 1 of each cycle. Beginning day 1 of each cycle, patients also undergo radiation therapy daily Monday-Friday. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-6 weeks after cycle 2, patients receive durvalumab IV over 60 minutes every 2 weeks or monthly for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI throughout the trial and PET/CT scan during screening and on study. After completion of study treatment, patients are followed up at 30 days, and then every 3 months for 2 years, followed by every 6 months for an additional 3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05198830
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase Phase 2
Start date December 15, 2022
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT02898857 - Chemoresistance and Involvement of the NOTCH Pathway in Patients With Lung Adenocarcinoma N/A
Completed NCT02127359 - Whole-Exome Sequencing (WES) of Cancer Patients
Recruiting NCT01249066 - Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma N/A
Not yet recruiting NCT04482829 - TCM in the Treatment of Lung Adenocarcinoma N/A
Recruiting NCT04929041 - Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Phase 2/Phase 3
Terminated NCT04691375 - A Study of PY314 in Subjects With Advanced Solid Tumors Phase 1
Terminated NCT02621333 - Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma Phase 2
Active, not recruiting NCT02282267 - Blood Detection of EGFR Mutation For Iressa Treatment N/A
Not yet recruiting NCT01942629 - Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas N/A
Recruiting NCT01482585 - Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy N/A
Recruiting NCT03376737 - Study of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma Phase 2
Recruiting NCT05537922 - I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Recruiting NCT04937283 - Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm N/A
Recruiting NCT06255197 - Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Completed NCT02093000 - A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma N/A
Recruiting NCT04119024 - Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors Phase 1
Terminated NCT04682431 - A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Phase 1
Recruiting NCT05736991 - Deep Learning Signature for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma
Enrolling by invitation NCT05136014 - Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2