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Spots Global Cancer Trial Database for Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Charles B Simone

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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