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NCT05624996 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer
A Phase 3 study of Stage III Lung Cancer AJCC v8 and Stage IIB Lung Cancer AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 474
- Enrollment target
- 20
- Study locations
NCT05624996 is a Phase 3 study of Stage III Lung Cancer AJCC v8 and Stage IIB Lung Cancer AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 474 participants, above the 88-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (439% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT05624996, a Phase 3 study of Stage III Lung Cancer AJCC v8 and Stage IIB Lung Cancer AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 474 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy \[IGRT\] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation therapy to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation therapy that creates a picture of the tumor to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Usual chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, and etoposide. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds. Cisplatin works by killing, stopping, or slowing the growth of tumor cells. Carboplatin 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 as well. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- BIOLOGICAL Durvalumab
- DRUG Etoposide
Study Locations (20)
California
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Mills-Peninsula Medical Center - Burlingame
- Palo Alto Medical Foundation-Fremont - Fremont
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Fremont - Rideout Cancer Center - Marysville
- Memorial Medical Center - Modesto
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- The Kirklin Clinic at Acton Road - Birmingham
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis - Daphne
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland - Saraland
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 474 participants |
| Start Date | 2023-07-12 |
| Est. Completion | 2031-10-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05624996
The ClinicalTrials.gov registry entry for NCT05624996 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 474 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 88-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (439% higher). The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 3 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.
NCT05624996 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05624996 about?
NCT05624996 is a clinical study titled "Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer". This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy \[IGRT\] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone...
What is the current status of trial NCT05624996?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 474 participants. The study started on 2023-07-12. Estimated completion is 2031-10-15.
What conditions does trial NCT05624996 study?
This clinical trial studies the following conditions: Stage III Lung Cancer AJCC v8, Stage IIB Lung Cancer AJCC v8, Locally Advanced Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT05624996?
The interventions under investigation include: Carboplatin (DRUG), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Durvalumab (BIOLOGICAL), Etoposide (DRUG).
Who is sponsoring clinical trial NCT05624996?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05624996 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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