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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: Recruiting Phase 2 study of Stage III Lung Cancer AJCC v8 and Lung Adenocarcinoma, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

PFS primary analysis will be performed using a stratified log-rank test (with the strata being the same as the randomization strata) with a one-sided significance level of 0.10.

Conditions Studied

Stage III Lung Cancer AJCC v8 Lung Adenocarcinoma Lung Non-Squamous Non-Small Cell Carcinoma Lung Large Cell Carcinoma

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

FieldValue
Enrollment Target 42 participants
Start Date 2022-12-15
Est. Completion 2027-06-30
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT05198830 shows while recruiting

NCT05198830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 99-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (58% lower).

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 names 20 study sites across 4 states, led by 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.

Learn More About Clinical Trials

Similar trials for Stage III Lung Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05198830's enrollment target sits among peer trials

42 22nd of 40 higher than 18 of 40 other Stage III Lung Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stage III Lung Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05198830

Source: ClinicalTrials.gov NCT05198830, the US trial registry maintained by the National Library of Medicine. NCT05198830 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.