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RECRUITING

NCT05624996

PHASE3

Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer

Sponsor: NRG Oncology

View on ClinicalTrials.gov

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 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

474

Start Date

2023-07-12

Completion Date

2036-10-15

Last Updated

2026-08-17

Healthy Volunteers

Conditions

Locally Advanced Lung Non-Small Cell Carcinoma Stage IIB Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8

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

RADIATION

Image Guided Radiation Therapy

Undergo IGRT

DRUG

Nab-paclitaxel

Given IV

DRUG

Osimertinib

Given PO

DRUG

Paclitaxel

Given IV

DRUG

Pemetrexed

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

OTHER

Questionnaire Administration

Ancillary studies

RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of non-operable stage IIB or III, node positive (American Joint Committee on Cancer \[AJCC\] eighth edition) non-small cell lung cancer (NSCLC) with known PD-L1 status prior to registration * Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial/hilar/intrapulmonary, mediastinal/subcarinal, supraclavicular/scalene) * Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different cancer is also permissible * Patients who refuse surgery, in addition to those who are technically unresectable or medically inoperable, are eligible. * Patients with separate tumor nodules in the same lobe of the primary tumor are eligible * The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments: * History/physical examination prior to registration; * Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the brain (if available, contrast is preferred for all neuroimaging) prior to registration; * CT chest with IV contrast (if contrast is available and unless contraindicated, such as for abnormal kidney function) prior to registration. PET/CT may be used if the CT portion is of identical diagnostic quality as achieved in a stand-alone CT * No evidence of distant metastases based on FDG PET/CT scan obtained within 60 days of registration * Primary tumor =\< 7 cm * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the discretion of the treating physician, to allow for treatment with chemotherapy and concurrent radiation therapy * Creatinine clearance \>= 25 mL/min by the Cockcroft-Gault (C-G) equation * Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion * If a pleural effusion is present, the following criteria must be met to exclude malignant involvement: * When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; * Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible * Medical history consistent with the patient being amenable, at the discretion of the treating physician, to allow for treating with consolidation immunotherapy. Patients with known EGFR/ALK/other driver mutation at the time of registration are eligible, and these patients can be treated with consolidation systemic therapy at the discretion of the treating physician * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen * Negative pregnancy test =\< 14 days prior to registration for participants of childbearing potential * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information Exclusion Criteria: * Prior radiotherapy to the study cancer (local recurrence). Prior radiotherapy for a different cancer/condition to the region of the study cancer that would result in overlap of radiation therapy fields that is determined by the treating physician to impede the treatment of the study malignancy * Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1 radiographically-involved lymph node is required, but pathologic confirmation of involvement is not mandated * Centrally located primary tumor \< 2 cm from involved nodal disease that would result in significant overlap of the primary SBRT and nodal radiation fields. This does not include proximity to involved segmental and subsegmental lymph nodes (levels 13 and 14) that would not result in overlap of dose to the proximal bronchial tree or esophagus. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi) * Participants who are pregnant or unwilling to discontinue nursing * Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe required after the final dose of the selected systemic therapy regimen, because the treatment in this study may be significantly teratogenic

Locations (477)

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

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

AIS Cancer Center at San Joaquin Community Hospital

Bakersfield, California, United States

Mills-Peninsula Medical Center

Burlingame, California, United States

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Mills Health Center

San Mateo, California, United States

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

UCHealth - Cherry Creek

Denver, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

UCHealth Lone Tree Health Center

Lone Tree, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Beebe Medical Center

Lewes, Delaware, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, United States

Bay Pines VA Healthcare System

Bay Pines, Florida, United States

Morton Plant Hospital

Clearwater, Florida, United States

Halifax Health Cancer Center for Hope - Daytona Beach

Daytona Beach, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Jupiter Medical Center

Jupiter, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Memorial Hospital West

Pembroke Pines, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Winter Haven Hospital

Winter Haven, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory Proton Therapy Center

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

WellStar Cobb Hospital

Austell, Georgia, United States

Hamilton Medical Center - Peeples Cancer Institute

Dalton, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza