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

Official 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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 474 participants

Interventions

• DRUG: Carboplatin — Given IV
• DRUG: Cisplatin — Given IV
• PROCEDURE: Computed Tomography — Undergo CT and/or PET/CT
• BIOLOGICAL: Durvalumab — Given IV
• DRUG: Etoposide — Given IV

Primary Outcomes

• Overall survival (OS) (Time between date of randomization and date of death due to any cause, assessed up to 8 years)
• Progression-free survival (PFS) (Time between date of randomization and first date of documented progression or death due to any cause, assessed up to 8 years)

Secondary Outcomes

• Objective response rate (ORR) (Up to 8 years)
• Time to progression (Up to 8 years)
• Time to primary, locoregional, or distant failure (Up to 8 years)
• Changes in pulmonary function (From randomization to 6 months or 12 months)
• Patient reported outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) (At 3, 12, and 24 months)

Trial Locations

• University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
• The Kirklin Clinic at Acton Road, Birmingham, Alabama, United States
• Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis, Daphne, Alabama, United States
• Thomas Hospital, Fairhope, Alabama, United States
• Mobile Infirmary Medical Center, Mobile, Alabama, United States
• Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland, Saraland, Alabama, United States
• Kingman Regional Medical Center, Kingman, Arizona, United States
• Cancer Center at Saint Joseph's, Phoenix, Arizona, United States
• Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
• Banner University Medical Center - Tucson, Tucson, Arizona, United States
• ...and 10 more locations

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