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.
Additional locations may be listed on ClinicalTrials.gov for NCT05624996 .
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Newark Rutgers New Jersey Medical School Status: Active
Contact: Site Public Contact
Phone: 732-235-7356
Sewell Sidney Kimmel Cancer Center Washington Township Status: Active
Contact: Site Public Contact
Phone: 215-600-9151
Somerville Robert Wood Johnson University Hospital Somerset Status: Active
Contact: Site Public Contact
Phone: 908-685-2481
Toms River Community Medical Center Status: Active
Contact: Site Public Contact
Phone: 732-557-8294
New Mexico Albuquerque University of New Mexico Cancer Center Status: Active
Contact: Site Public Contact
Phone: 505-925-0348
Presbyterian Kaseman Hospital Status: Active
Contact: Site Public Contact
Phone: 505-559-6113
Las Cruces Memorial Medical Center-Las Cruces Status: Active
Contact: Site Public Contact
Phone: 575-556-6545
Rio Rancho Presbyterian Rust Medical Center/Jorgensen Cancer Center Status: Active
Contact: Site Public Contact
Phone: 505-559-6113
New York Batavia Wilmot Cancer Center at Batavia Status: Temporarily closed to accrual
Contact: Site Public Contact
Bronx Montefiore Medical Center-Einstein Campus Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center-Weiler Hospital Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Montefiore Medical Center - Moses Campus Status: Active
Contact: Site Public Contact
Phone: 718-379-6866
Canandiaqua Sands Cancer Center Status: Active
Contact: Site Public Contact
Phone: 585-396-6161
Commack Memorial Sloan Kettering Commack Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Glens Falls Glens Falls Hospital Status: Active
Contact: Site Public Contact
Phone: 518-926-6700
New York New York Proton Center Status: Active
Contact: Site Public Contact
Phone: 646-968-9031
Memorial Sloan Kettering Cancer Center Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Rochester University of Rochester Status: Active
Contact: Site Public Contact
Phone: 585-275-5830
Highland Hospital Status: Active
Contact: Site Public Contact
Phone: 585-341-8113
Wilmot Cancer Institute Radiation Oncology at Greece Status: Active
Contact: Site Public Contact
Phone: 585-758-7877
Stony Brook Stony Brook University Medical Center Status: Active
Contact: Site Public Contact
Phone: 800-862-2215
Syracuse State University of New York Upstate Medical University Status: Active
Contact: Site Public Contact
Phone: 315-464-5476
Uniondale Memorial Sloan Kettering Nassau Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
Valhalla Westchester Medical Center Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Webster Wilmot Cancer Institute at Webster Status: Active
Contact: Site Public Contact
West Harrison Memorial Sloan Kettering Westchester Status: Active
Contact: Site Public Contact
Phone: 212-639-7592
North Carolina Albemarle Atrium Health Stanly/LCI-Albemarle Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Cary Duke Cancer Center Cary Status: Active
Contact: Site Public Contact
Chapel Hill UNC Lineberger Comprehensive Cancer Center Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Charlotte Novant Health Presbyterian Medical Center Status: Active
Contact: Site Public Contact
Phone: 980-201-6360
Carolinas Medical Center/Levine Cancer Institute Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Levine Cancer Institute-Ballantyne Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Atrium Health University City/LCI-University Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Atrium Health Pineville/LCI-Pineville Status: Active
Contact: Site Public Contact
Phone: 980-442-2000
Clemmons Wake Forest University at Clemmons Status: Active
Contact: Site Public Contact
Phone: 888-716-9259
Concord Atrium Health Cabarrus/LCI-Concord Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Durham Duke University Medical Center Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Forest City Levine Cancer Institute - Rutherford Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Gastonia CaroMont Regional Medical Center Status: Active
Contact: Site Public Contact
Phone: 704-834-2810
Greensboro Novant Health Breast Surgery - Greensboro Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Huntersville Novant Health Cancer Institute - Huntersville Status: Active
Contact: Site Public Contact
Phone: 980-201-6360
Novant Health Presbyterian Medical Center Huntersville Status: Active
Contact: Site Public Contact
Phone: 980-201-6360
Kernersville Novant Health Cancer Institute - Kernersville Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Matthews Matthews Radiation Oncology Center Status: Active
Contact: Site Public Contact
Phone: 980-201-6360
Novant Health Cancer Institute - Matthews Status: Active
Contact: Site Public Contact
Phone: 980-201-6360
Levine Cancer Institute - Union West Status: Active
Contact: Site Public Contact
Phone: 980-442-0600
Monroe Atrium Health Union/LCI-Union Status: Active
Contact: Site Public Contact
Phone: 980-442-2000
Mooresville Novant Health Cancer Institute - Mooresville Status: Active
Contact: Site Public Contact
Phone: 980-201-6360
Mount Airy Novant Health Cancer Institute - Mount Airy Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
North Wilkesboro Novant Health Cancer Institute - Wilkesboro Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Raleigh Duke Cancer Center Raleigh Status: Active
Contact: Site Public Contact
Salisbury Novant Health Cancer Institute - Rowan Status: Active
Contact: Site Public Contact
Phone: 980-201-6360
Rowan Regional Medical Center Status: Active
Contact: Site Public Contact
Phone: 704-210-5000
Shelby Atrium Health Cleveland/LCI-Cleveland Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Statesville Wake Forest Baptist Health - Hematology Oncology - Statesville Status: Active
Contact: Site Public Contact
Phone: 704-872-3630
Stateville Novant Health Cancer Institute - Statesville Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Supply Novant Cancer Institute Radiation Oncology - Supply Status: Active
Contact: Site Public Contact
Phone: 910-754-4716
Thomasville Novant Health Cancer Institute - Thomasville Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Wilkesboro Wake Forest Baptist Health - Wilkes Medical Center Status: Active
Contact: Site Public Contact
Phone: 888-716-9253
Wilmington Novant Health Cancer Institute Radiation Oncology - Wilmington Status: Active
Contact: Site Public Contact
Phone: 910-251-1839
Novant Health New Hanover Regional Medical Center Status: Active
Contact: Site Public Contact
Phone: 910-342-3000
Winston-Salem Novant Health Forsyth Medical Center Status: Active
Contact: Site Public Contact
Phone: 336-718-8335
Wake Forest University Health Sciences Status: Active
Contact: Site Public Contact
Phone: 336-713-6771
North Dakota Bismarck Sanford Bismarck Medical Center Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Fargo Sanford Roger Maris Cancer Center Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Sanford Broadway Medical Center Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Grand Forks Altru Cancer Center Status: Active
Contact: Site Public Contact
Phone: 701-780-6520
Ohio Akron Cleveland Clinic Akron General Status: Active
Contact: Site Public Contact
Phone: 866-223-8100
Avon UH Seidman Cancer Center at UH Avon Health Center Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Beachwood UHHS-Chagrin Highlands Medical Center Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Canton Aultman Health Foundation Status: Active
Contact: Site Public Contact
Phone: 330-363-7274
Cleveland Clinic Mercy Hospital Status: Active
Contact: Site Public Contact
Phone: 888-293-4673
Centerville Miami Valley Hospital South Status: Active
Contact: Site Public Contact
Phone: 937-528-2900
Cleveland Case Western Reserve University Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Columbus Doctors Hospital Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Riverside Methodist Hospital Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Grant Medical Center Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Dayton Miami Valley Hospital North Status: Active
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital Status: Active
Contact: Site Public Contact
Phone: 937-528-2900
Premier Blood and Cancer Center Status: Active
Contact: Site Public Contact
Phone: 937-276-8320
Delaware Delaware Health Center-Grady Cancer Center Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Grady Memorial Hospital Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Dublin Dublin Methodist Hospital Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Franklin Atrium Medical Center-Middletown Regional Hospital Status: Active
Contact: Site Public Contact
Phone: 937-528-2900
Greenville Miami Valley Cancer Care and Infusion Status: Active
Contact: Site Public Contact
Phone: 937-569-7515
Mansfield OhioHealth Mansfield Hospital Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Marion OhioHealth Marion General Hospital Status: Active
Contact: Site Public Contact
Phone: 614-788-3860
Mentor UH Seidman Cancer Center at Lake Health Mentor Campus Status: Active
Contact: Site Public Contact
Phone: 800-641-2422
Perrysburg Mercy Health - Perrysburg Hospital Status: Active
Contact: Site Public Contact
Phone: 614-488-2745
Troy Upper Valley Medical Center Status: Active
Contact: Site Public Contact
Phone: 937-528-2900
Oklahoma Oklahoma City University of Oklahoma Health Sciences Center Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Oregon Gresham Legacy Mount Hood Medical Center Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
Portland Legacy Good Samaritan Hospital and Medical Center Status: Active
Contact: Site Public Contact
Phone: 800-220-4937
Tualatin Legacy Meridian Park Hospital Status: Active
Contact: Site Public Contact
Phone: 503-413-1742
Pennsylvania Chadds Ford Christiana Care Health System-Concord Health Center Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Chambersburg Chambersburg Hospital Status: Active
Contact: Site Public Contact
Phone: 412-339-5294
Danville Geisinger Medical Center Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Ephrata Ephrata Cancer Center Status: Active
Contact: Site Public Contact
Phone: 717-721-4840
Gettysburg Adams Cancer Center Status: Active
Contact: Site Public Contact
Phone: 877-441-7957
Hershey Penn State Milton S Hershey Medical Center Status: Active
Contact: Site Public Contact
Phone: 717-531-3779
Lancaster Lancaster General Ann B Barshinger Cancer Institute Status: Active
Contact: Site Public Contact
Phone: 717-544-0511
Lebanon Sechler Family Cancer Center Status: Active
Contact: Site Public Contact
Phone: 717-741-8303
Lewisburg Geisinger Medical Oncology-Lewisburg Status: Active
Contact: Site Public Contact
Phone: 570-374-8555
Philadelphia Thomas Jefferson University Hospital Status: Active
Contact: Site Public Contact
Phone: 215-600-9151
University of Pennsylvania/Abramson Cancer Center Status: Active
Contact: Site Public Contact
Phone: 215-349-8245
Temple University Hospital Status: Active
Contact: Site Public Contact
Phone: 215-728-2983
Fox Chase Cancer Center Status: Active
Contact: Site Public Contact
Phone: 215-728-4790
West Reading Reading Hospital Status: Active
Contact: Site Public Contact
Phone: 610-988-9323
Wilkes-Barre Geisinger Wyoming Valley/Henry Cancer Center Status: Active
Contact: Site Public Contact
Phone: 570-271-5251
Willow Grove Asplundh Cancer Pavilion Status: Active
Contact: Site Public Contact
Phone: 215-600-9151
Wynnewood Lankenau Medical Center Status: Active
Contact: Site Public Contact
Phone: 484-476-2649
York WellSpan Health-York Hospital Status: Active
Contact: Site Public Contact
Phone: 877-441-7957
WellSpan Health-York Cancer Center Status: Active
Contact: Site Public Contact
Phone: 877-441-7957
South Carolina Gaffney Gibbs Cancer Center-Gaffney Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Greer Gibbs Cancer Center-Pelham Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Lancaster Lancaster Radiation Therapy Center Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Rock Hill Levine Cancer Institute-Rock Hill Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Rock Hill Radiation Therapy Center Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Spartanburg Spartanburg Medical Center Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
Union SMC Center for Hematology Oncology Union Status: Active
Contact: Site Public Contact
Phone: 864-560-6104
West Columbia Lexington Medical Center Status: Active
Contact: Site Public Contact
Phone: 803-935-8300
South Dakota Sioux Falls Sanford USD Medical Center - Sioux Falls Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Sanford Cancer Center Oncology Clinic Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Tennessee Collierville Baptist Memorial Hospital and Cancer Center-Collierville Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Memphis Baptist Memorial Hospital and Cancer Center-Memphis Status: Active
Contact: Site Public Contact
Phone: 901-226-1366
Texas Conroe MD Anderson in The Woodlands Status: Active
Contact: Site Public Contact
Phone: 866-632-6789
Houston M D Anderson Cancer Center Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
MD Anderson West Houston Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
League City MD Anderson League City Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Sugar Land MD Anderson in Sugar Land Status: Active
Contact: Site Public Contact
Phone: 877-632-6789
Vermont Berlin Central Vermont Medical Center/National Life Cancer Treatment Status: Active
Contact: Site Public Contact
Phone: 802-225-5400
Burlington University of Vermont Medical Center Status: Active
Contact: Site Public Contact
Phone: 802-656-4101
University of Vermont and State Agricultural College Status: Active
Contact: Site Public Contact
Phone: 802-656-8990
Saint Johnsbury Dartmouth Cancer Center - North Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Washington Vancouver Legacy Cancer Institute Medical Oncology and Day Treatment Status: Active
Contact: Site Public Contact
Legacy Salmon Creek Hospital Status: Active
Contact: Site Public Contact
Phone: 503-413-2150
West Virginia Huntington Edwards Comprehensive Cancer Center Status: Active
Contact: Site Public Contact
Phone: 304-399-6566
Morgantown West Virginia University Healthcare Status: Active
Contact: Site Public Contact
Phone: 304-293-7374
Wisconsin Antigo Langlade Hospital and Cancer Center Status: Active
Contact: Site Public Contact
Phone: 715-623-9869
Ashland Northwest Wisconsin Cancer Center Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Duluth Clinic Ashland Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Burlington Aurora Cancer Care-Southern Lakes VLCC Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Eau Claire HSHS Sacred Heart Hospital Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 920-433-8889
Marshfield Medical Center-EC Cancer Center Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Germantown Aurora Health Care Germantown Health Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Grafton Aurora Cancer Care-Grafton Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay Aurora BayCare Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Saint Vincent Hospital Cancer Center Green Bay Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Hayward Essentia Health-Hayward Clinic Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Johnson Creek University of Wisconsin Carbone Cancer Center - Johnson Creek Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
Kenosha Aurora Cancer Care-Kenosha South Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Madison University of Wisconsin Carbone Cancer Center - University Hospital Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Status: Active
Contact: Site Public Contact
Phone: 800-622-8922
William S Middleton VA Medical Center Status: Active
Contact: Site Public Contact
Phone: 608-256-1901ext17007
Marinette Aurora Bay Area Medical Group-Marinette Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Marshfield Marshfield Medical Center-Marshfield Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Menomonee Falls Froedtert Menomonee Falls Hospital Status: Active
Contact: Site Public Contact
Phone: 262-257-5100
Milwaukee Aurora Cancer Care-Milwaukee Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Sinai Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Saint Luke's Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Medical College of Wisconsin Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
Zablocki Veterans Administration Medical Center Status: Active
Contact: Site Public Contact
Phone: 888-469-6614
Minocqua Marshfield Medical Center - Minocqua Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Mukwonago ProHealth D N Greenwald Center Status: Active
Contact: Site Public Contact
Oak Creek Drexel Town Square Health Center Status: Active
Contact: Site Public Contact
Phone: 414-805-0505
Oconomowoc ProHealth Oconomowoc Memorial Hospital Status: Active
Contact: Site Public Contact
Phone: 262-928-7878
Oshkosh Vince Lombardi Cancer Clinic - Oshkosh Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Racine Aurora Cancer Care-Racine Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Rhinelander Aspirus Cancer Care - James Beck Cancer Center Status: Active
Contact: Site Public Contact
Phone: 715-847-2353
Rice Lake Marshfield Medical Center-Rice Lake Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Sheboygan Vince Lombardi Cancer Clinic-Sheboygan Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Saint Vincent Hospital Cancer Center at Sheboygan Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Spooner Essentia Health-Spooner Clinic Status: Active
Contact: Site Public Contact
Phone: 218-786-3308
Stevens Point Aspirus Cancer Care - Stevens Point Status: Active
Contact: Site Public Contact
Phone: 715-847-2353
Marshfield Medical Center-River Region at Stevens Point Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Sturgeon Bay Saint Vincent Hospital Cancer Center at Sturgeon Bay Status: Active
Contact: Site Public Contact
Phone: 920-433-8889
Summit Aurora Medical Center in Summit Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
Superior Essentia Health Saint Mary's Hospital - Superior Status: Active
Contact: Site Public Contact
Phone: 701-364-6272
Waukesha UW Cancer Center at ProHealth Care Status: Active
Contact: Site Public Contact
Phone: 262-928-5539
Wausau Aspirus Regional Cancer Center Status: Active
Contact: Site Public Contact
Phone: 877-405-6866
Wauwatosa Aurora Cancer Care-Milwaukee West Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
West Allis Aurora West Allis Medical Center Status: Active
Contact: Site Public Contact
Phone: 414-302-2304
West Bend Froedtert West Bend Hospital/Kraemer Cancer Center Status: Active
Contact: Site Public Contact
Phone: 414-805-0505
Weston Marshfield Medical Center - Weston Status: Active
Contact: Site Public Contact
Phone: 800-782-8581
Wisconsin Rapids Aspirus Cancer Care - Wisconsin Rapids Status: Active
Contact: Site Public Contact
Phone: 715-422-7718
PRIMARY OBJECTIVES:
I. To compare the overall survival in patients with stage II-IIIC inoperable node-positive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (Arm 1) or after image guided, motion-managed stereotactic body radiation therapy (SBRT) to the primary tumor followed by conventionally fractionated radiotherapy to nodal metastases (Arm 2) both given with concurrent platinum-based chemotherapy.
II. To compare progression-free survival between the experimental arm (Arm 2) and control arm (Arm 1).
SECONDARY OBJECTIVES:
I. To compare objective response rate (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1) between the experimental arm and control arm.
II. To compare the rate of local control between the experimental arm and control arm.
III. To compare patterns of failure (primary, locoregional, or distant) between the experimental arm and control arm.
IV. To compare changes in pulmonary function (forced expiratory volume in 1 second [FEV1] and diffusion capacity of the lung for carbon monoxide [DLCO] assessed at randomization and at 6- and 12- months following completion of radiation therapy) between the experimental arm and control arm.
V. To compare changes in quality of life and patient-reported outcomes assessed from pre-treatment to 3 months following radiation therapy of each treatment arm.
VI. To determine acute and late toxicity profiles of each treatment arm as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5.
EXPLORATORY OBJECTIVES:
I. To characterize and compare longitudinal quality of life and patient-reported outcomes of each treatment arm.
II. To collect biospecimens at baseline, after SBRT (for Arm 2 patients), during last 2 weeks of chemoradiation, and after first dose of consolidation therapy, to allow for future analyses.
III. To collect 4-dimensional (4D) computed tomography (CT) planning scans and radiation dose to calculate regional lung ventilation and explore pre-treatment 4D-CT based ventilation to predict pulmonary toxicity.
IV. To characterize clinical outcomes, toxicities and changes in pulmonary function and quality of life among patients receiving proton and photon radiotherapy.
V. To develop and characterize a machine learning/artificial intelligence algorithm for radiotherapy planning and/or quality assurance.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo conventional IGRT and receive usual care chemotherapy consisting of paclitaxel intravenously (IV) followed by carboplatin IV weekly (Q7D) during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or positron emission tomography (PET)/CT during follow-up.
ARM II: Patients undergo SBRT and conventional IGRT and then receive standard-of-care chemotherapy consisting of paclitaxel IV followed by carboplatin IV Q7D during radiotherapy or pemetrexed IV followed by carboplatin IV every 21 days during radiotherapy or etoposide IV on days 1 to 5 and days 29 to 33 followed by cisplatin IV on days 1, 8, 29, and 36 or pemetrexed IV followed by cisplatin IV every 21 days during radiotherapy. Patients then receive consolidation durvalumab IV every 2 or 4 weeks for up to one year or osimertinib PO QD in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT during follow-up.
Patients are followed up every 3 months for 1 year, every 6 months during years 2 and 3, and then yearly after that for the duration of the study.
Lead Organization NRG Oncology
Principal Investigator Charles B. Simone