The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer
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
Study ID: NCT05624996
Brief Summary: This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy \[IGRT\] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation 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 that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It 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. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. 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 DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.
Detailed Description: 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. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel intravenously (IV) and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or positron emission tomography (PET)/CT during follow up. ARM II: Patients undergo SBRT and conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Cancer Center at Saint Joseph's, Phoenix, Arizona, United States
Banner University Medical Center - Tucson, Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
AIS Cancer Center at San Joaquin Community Hospital, Bakersfield, California, United States
Mills-Peninsula Medical Center, Burlingame, 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
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
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
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
Morton Plant Hospital, Clearwater, 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
Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Kuakini Medical Center, Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii, United States
Rush - Copley Medical Center, Aurora, Illinois, United States
Advocate Good Shepherd Hospital, Barrington, Illinois, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center, Chicago, Illinois, United States
AMG Crystal Lake - Oncology, Crystal Lake, Illinois, United States
Carle at The Riverfront, Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Advocate Sherman Hospital, Elgin, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States
Advocate South Suburban Hospital, Hazel Crest, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
AMG Libertyville - Oncology, Libertyville, Illinois, United States
Condell Memorial Hospital, Libertyville, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Advocate Lutheran General Hospital, Park Ridge, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Illinois CancerCare - Washington, Washington, Illinois, United States
Mary Greeley Medical Center, Ames, Iowa, United States
McFarland Clinic - Ames, Ames, Iowa, United States
Mission Cancer and Blood - Ankeny, Ankeny, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Mission Cancer and Blood - Laurel, Des Moines, Iowa, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Anne Arundel Medical Center, Annapolis, Maryland, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
McLaren Cancer Institute-Bay City, Bay City, Michigan, United States
Saint Joseph Mercy Brighton, Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States
McLaren Cancer Institute-Clarkston, Clarkston, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States
McLaren Cancer Institute-Flint, Flint, Michigan, United States
Karmanos Cancer Institute at McLaren Greater Lansing, Lansing, Michigan, United States
Sparrow Hospital, Lansing, Michigan, United States
McLaren Cancer Institute-Lapeer Region, Lapeer, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States
McLaren Cancer Institute-Macomb, Mount Clemens, Michigan, United States
McLaren Cancer Institute-Northern Michigan, Petoskey, Michigan, United States
21st Century Oncology-Pontiac, Pontiac, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
McLaren-Port Huron, Port Huron, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States
Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, Minnesota, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Parkland Health Center - Farmington, Farmington, Missouri, United States
Mercy Hospital South, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri, United States
Renown Regional Medical Center, Reno, Nevada, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Wilmot Cancer Center at Batavia, Batavia, New York, United States
Montefiore Medical Center-Einstein Campus, Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Sands Cancer Center, Canandaigua, New York, United States
Memorial Sloan Kettering Commack, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
New York Proton Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Wilmot Cancer Institute Radiation Oncology at Greece, Rochester, New York, United States
Highland Hospital, Rochester, New York, United States
University of Rochester, Rochester, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Westchester Medical Center, Valhalla, New York, United States
Wilmot Cancer Institute at Webster, Webster, New York, United States
Atrium Health Stanly/LCI-Albemarle, Albemarle, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Atrium Health Pineville/LCI-Pineville, Charlotte, North Carolina, United States
Atrium Health University City/LCI-University, Charlotte, North Carolina, United States
Wake Forest University at Clemmons, Clemmons, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, United States
CaroMont Regional Medical Center, Gastonia, North Carolina, United States
Novant Health Cancer Institute - Huntersville, Huntersville, North Carolina, United States
Novant Health Presbyterian Medical Center Huntersville, Huntersville, North Carolina, United States
Novant Health Cancer Institute - Kernersville, Kernersville, North Carolina, United States
Levine Cancer Institute - Union West, Matthews, North Carolina, United States
Matthews Radiation Oncology Center, Matthews, North Carolina, United States
Novant Health Cancer Institute - Matthews, Matthews, North Carolina, United States
Atrium Health Union/LCI-Union, Monroe, North Carolina, United States
Novant Health Cancer Institute - Mooresville, Mooresville, North Carolina, United States
Novant Health Cancer Institute - Mount Airy, Mount Airy, North Carolina, United States
Novant Health Cancer Institute - Rowan, Salisbury, North Carolina, United States
Rowan Regional Medical Center, Salisbury, North Carolina, United States
Atrium Health Cleveland/LCI-Cleveland, Shelby, North Carolina, United States
Novant Health Cancer Institute - Statesville, Statesville, North Carolina, United States
Wake Forest Baptist Health - Hematology Oncology - Statesville, Statesville, North Carolina, United States
Novant Cancer Institute Radiation Oncology - Supply, Supply, North Carolina, United States
Novant Health Cancer Institute - Thomasville, Thomasville, North Carolina, United States
Novant Health Cancer Institute - Wilkesboro, Wilkesboro, North Carolina, United States
Wake Forest Baptist Health - Wilkes Medical Center, Wilkesboro, North Carolina, United States
Novant Health Cancer Institute Radiation Oncology - Wilmington, Wilmington, North Carolina, United States
Novant Health New Hanover Regional Medical Center, Wilmington, North Carolina, United States
Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Altru Cancer Center, Grand Forks, North Dakota, United States
Cleveland Clinic Akron General, Akron, Ohio, United States
Cleveland Clinic Mercy Hospital, Canton, Ohio, United States
Miami Valley Hospital South, Centerville, Ohio, United States
Dayton Blood and Cancer Center, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Dayton Physician LLC-Miami Valley Hospital North, Dayton, Ohio, United States
Miami Valley Hospital North, Dayton, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Miami Valley Cancer Care and Infusion, Greenville, Ohio, United States
Mercy Health Perrysburg Cancer Center, Perrysburg, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Legacy Mount Hood Medical Center, Gresham, Oregon, United States
Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, United States
Legacy Meridian Park Hospital, Tualatin, Oregon, United States
Christiana Care Health System-Concord Health Center, Chadds Ford, Pennsylvania, United States
Chambersburg Hospital, Chambersburg, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Ephrata Cancer Center, Ephrata, Pennsylvania, United States
Adams Cancer Center, Gettysburg, Pennsylvania, United States
Sechler Family Cancer Center, Lebanon, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Reading Hospital, West Reading, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
Asplundh Cancer Pavilion, Willow Grove, Pennsylvania, United States
WellSpan Health-York Cancer Center, York, Pennsylvania, United States
WellSpan Health-York Hospital, York, Pennsylvania, United States
Rock Hill Radiation Therapy Center, Rock Hill, South Carolina, United States
Levine Cancer Institute-Rock Hill, Rock Hill, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
MD Anderson in The Woodlands, Conroe, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
MD Anderson West Houston, Houston, Texas, United States
MD Anderson League City, League City, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
University of Vermont Medical Center, Burlington, Vermont, United States
University of Vermont and State Agricultural College, Burlington, Vermont, United States
Norris Cotton Cancer Center-North, Saint Johnsbury, Vermont, United States
Legacy Cancer Institute Medical Oncology and Day Treatment, Vancouver, Washington, United States
Legacy Salmon Creek Hospital, Vancouver, Washington, United States
Langlade Hospital and Cancer Center, Antigo, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, United States
HSHS Sacred Heart Hospital, Eau Claire, Wisconsin, United States
Aurora Health Care Germantown Health Center, Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States
Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, United States
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette, Marinette, Wisconsin, United States
Froedtert Menomonee Falls Hospital, Menomonee Falls, Wisconsin, United States
Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Zablocki Veterans Administration Medical Center, Milwaukee, Wisconsin, United States
ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States
Drexel Town Square Health Center, Oak Creek, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine, Racine, Wisconsin, United States
Ascension Saint Mary's Hospital, Rhinelander, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sheboygan, Sheboygan, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, United States
Ascension Saint Michael's Hospital, Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit, Summit, Wisconsin, United States
UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States
Aspirus Regional Cancer Center, Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Froedtert West Bend Hospital/Kraemer Cancer Center, West Bend, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids, Wisconsin Rapids, Wisconsin, United States
Name: Charles B Simone
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR