Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer (NCT05624996)
Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer
๐ฉบ Plain-English Summary (8th-Grade Level)
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 for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Immunotherapy with durvalumab can induce changes in the body's immune system and can interfere with the ability of tumor cells to grow and spread. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Adding SBRT to the usual treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with locally-advanced non-small cell lung cancer than giving the usual treatment alone.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center โ Birmingham, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (477 Sites)
Showing the first 25 of 477 sites.
- University of Alabama at Birmingham Cancer Center โ Birmingham, Alabama
- The Kirklin Clinic at Acton Road โ Birmingham, Alabama
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis โ Daphne, Alabama
- Thomas Hospital โ Fairhope, Alabama
- Mobile Infirmary Medical Center โ Mobile, Alabama
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland โ Saraland, Alabama
- Kingman Regional Medical Center โ Kingman, Arizona
- Cancer Center at Saint Joseph's โ Phoenix, Arizona
- Mayo Clinic Hospital in Arizona โ Phoenix, Arizona
- Banner University Medical Center - Tucson โ Tucson, Arizona
- University of Arizona Cancer Center-North Campus โ Tucson, Arizona
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro โ Jonesboro, Arkansas
- University of Arkansas for Medical Sciences โ Little Rock, Arkansas
- AIS Cancer Center at San Joaquin Community Hospital โ Bakersfield, California
- Mills-Peninsula Medical Center โ Burlingame, California
- Palo Alto Medical Foundation-Fremont โ Fremont, California
- Los Angeles General Medical Center โ Los Angeles, California
- USC / Norris Comprehensive Cancer Center โ Los Angeles, California
- Fremont - Rideout Cancer Center โ Marysville, California
- Memorial Medical Center โ Modesto, California
- Palo Alto Medical Foundation-Camino Division โ Mountain View, California
- Palo Alto Medical Foundation Health Care โ Palo Alto, California
- Sutter Cancer Centers Radiation Oncology Services-Roseville โ Roseville, California
- Sutter Roseville Medical Center โ Roseville, California
- Sutter Medical Center Sacramento โ Sacramento, California
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Locally Advanced Lung Non-Small Cell Carcinoma
- Brigatinib and Bevacizumab for the Treatment of ALK-Rearranged Locally Advanced, Metastatic, or Recurrent NSCLC โ Duarte, California
- Adaptive Radiation Planning for the Reduction of Radiation-Induced Toxicity in Patients With Stage II-IV Non-small Cell Lung Cancer โ New Brunswick, New Jersey
- Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation โ Sacramento, California
- Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer โ Duarte, California
- Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation โ Houston, Texas
Explore by condition: All Locally Advanced Lung Non-Small Cell Carcinoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.