Targeted Treatment for RET Fusion-Positive Advanced Non-Small Cell Lung Cancer (A LUNG-MAP Treatment Trial)

Sponsor
Southwest Oncology Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04268550
Collaborator
National Cancer Institute (NCI) (NIH)
124
306
1
36.6
0.4
0

Study Details

Study Description

Brief Summary

This phase II LUNG-MAP treatment trial studies how well selpercatinib works in treating patients with RET fusion-positive non-small cell lung cancer that is stage IV or has come back (recurrent). Selpercatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description

PRIMARY OBJECTIVE:
  1. To evaluate the objective response rate (ORR) (confirmed complete or partial response) by blinded independent centralized review (BICR) associated with selpercatinib (LOXO-292) in patients with previously-treated stage IV or recurrent RET fusion-positive non-small cell lung cancer (NSCLC).
SECONDARY OBJECTIVES:
  1. To evaluate the duration of BICR-assessed response among BICR responders. II. To evaluate the frequency and severity of toxicities. III. To evaluate the investigator-assessed objective response rate (confirmed complete or partial response).

  2. To evaluate duration of investigator-assessed response among patients with a response as determined by the local investigator.

  3. To evaluate investigator-assessed progression-free survival (IA-PFS). VI. To evaluate BICR-assessed PFS. VII. To evaluate overall survival (OS).

VIII. Among patients with brain metastases at baseline:

VIIIa. To evaluate the central nervous system (CNS) response rate (confirmed complete response [CR]).

VIIIb. To evaluate the duration of intracranial response among patients with a CNS response.

TRANSLATIONAL MEDICINE OBJECTIVES:
  1. To collect, process, and bank cell-free deoxyribonucleic acid (cfDNA) at baseline, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor deoxyribonucleic acid (ctDNA).

  2. To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).

OUTLINE:

Patients receive selpercatinib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then at the end of 3 years from date of sub-study registration.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of LOXO-292 in Patients With RET Fusion-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)
Actual Study Start Date :
Feb 10, 2020
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (selpercatinib)

Patients receive selpercatinib orally PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Selpercatinib
Given PO
Other Names:
  • LOXO-292
  • RET Kinase Inhibitor LOXO-292
  • Outcome Measures

    Primary Outcome Measures

    1. Response rate by blinded independent centralized review (BICR) [Up to 3 years from date of sub-study registration]

      A response will be confirmed by a complete response (CR) or partial response (PR). Proportions and associated confidence intervals will be calculated.

    Secondary Outcome Measures

    1. Incidence of adverse events [Up to 3 years from date of sub-study registration]

      Will be assessed using Common Terminology Criteria for Adverse Event version 5.0.

    2. BICR-progression-free survival (PFS) [From date of sub-study registration to date of first documentation of progression assessed by BICR or symptomatic deterioration, or death due to any cause, assessed up to 3 years from date of sub-study registration]

      Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    3. Investigator-assessed (IA) PFS [From date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause, assessed up to 3 years from date of sub-study registration]

      Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    4. Overall survival [Up to 3 years from date of sub-study registration]

      Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    5. BICR-duration of response (DOR) [From date of first documentation of confirmed response (CR or PR) to date of first documentation of progression assessed by BICR or symptomatic deterioration, or death due to any cause among patients who achieve, assessed at 6 and 12 months]

      Will be evaluated among patients who achieve a confirmed response. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times. The median DOR and percentage with DOR at landmark times at 6 and 12 months after documentation of confirmed response will be estimated.

    6. Central nervous system (CNS) response rate [Baseline]

      Will be assessed among patients with brain metastases. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    7. Duration of intracranial response among patients with a CNS response [Baseline]

      Will be assessed among patients with brain metastases. Will be estimated using the method of Kaplan-Meier. The Brookmeyer-Crowley method will be used to estimate confidence intervals for the median using Greenwood's formula and based on a log-log transformation applied on the survival function for landmark times

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients must have been assigned to S1900B based on biomarker analysis of tissue and/or blood and determined to have RET fusion-positive NSCLC as defined here:

    • Patients must have RET fusion-positive NSCLC as determined by the Foundation Medicine (FMI) tissue-assay, other tumor-based assays such as next-generation sequencing (NGS), polymerase chain reaction (PCR), or follicular in situ hybridization (FISH), or by cfDNA blood assay. Patients with RET fusions detected by immunohistochemistry (IHC) alone are not eligible. The testing must be done within a laboratory with Clinical Laboratory Improvement Act (CLIA), International Organization for Standardization (ISO/International Electrotechnical Commission (IEC), College of American Pathologists (CAP), or similar certification. Presence of RET fusions detected on tests performed outside of LUNGMAP must have been confirmed by the study biomarker review panel

    • For patients whose prior therapy was for stage IV or recurrent disease, the patient must have received at least one line of a platinum-based chemotherapy regimen. For patients whose prior systemic therapy was for stage I-III disease only (i.e. patient has not received any treatment for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that the patient received that therapy. Prior anti-PD-1/PD-L1 therapy, alone or in combination (e.g. nivolumab, pembrolizumab, or durvalumab) is allowed

    • Patients must be negative for all additional validated oncogenic drivers that could cause resistance to LOXO-292 treatment. This includes EGFR sensitizing mutations, EGFR T790M, ALK gene fusion, ROS1 gene fusion, KRAS activating mutation, BRAF V600E mutation and MET exon 14 skipping mutation or high-level amplification and expression

    • Note: EGFR, ALK, ROS, KRAS, and BRAF testing is performed as part of the LUNGMAP screening/pre-screening FoundationOne test. If prior data is not available, results from the FMI testing must be obtained prior to sub-study registration

    • Patients must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. Measurable disease must be assessed within 28 days prior to sub-study registration. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non-measurable disease must be assessed within 42 days prior to sub-study registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form. Patients whose only measurable disease is within a previous radiation therapy port must demonstrate clearly progressive disease (in the opinion of the treating investigator) prior to registration. CT and MRI scans must be submitted for central review via transfer of images and data (TRIAD)

    • Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 42 days prior to sub-study registration

    • Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration

    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. Patients with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration

    • Patients with known human immunodeficiency virus (HIV) infection are eligible, provided they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 6 months prior to registration

    • Patients must be able to swallow capsules

    • Patients must have progressed (in the opinion of the treating physician) following the most recent line of therapy

    • Patients must have recovered (=< grade 1) from any side effects of prior therapy. Patients must not have received any radiation therapy within 14 days prior to sub-study registration

    • Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration)

    • Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration)

    • Serum bilirubin =< institutional upper limit of normal (IULN) (within 28 days prior to sub-study registration). For patients with liver metastases, bilirubin must be =< 5 x IULN

    • Either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =< 2 x IULN (within 28 days prior to sub-study registration) (if both ALT and AST are done, both must be =< 2 IULN). For patients with liver metastases, bilirubin and either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)

    • Serum creatinine =< the IULN or calculated creatinine clearance >= 50 mL/min using the following Cockcroft-Gault formula (within 28 days prior to sub-study registration)

    • Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration

    • Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration

    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years

    • Patients must have electrolytes and blood urea nitrogen (BUN) performed within 14 days prior to sub-study registration

    • Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)

    • Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens

    • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

    • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

    • Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)

    Exclusion Criteria:
    • Patients must not have received any prior treatment with selective anti-RET inhibitors (anti-RET multikinase inhibitors are permitted)

    • Patient must not have leptomeningeal disease, spinal cord compression or brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration

    • Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 14 days prior to sub-study registration

    • Patients must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study. Concurrent use of hormones for non-cancer-related conditions (e.g., insulin for diabetes and hormone replacement therapy) is acceptable

    • Patient must not have had a major surgery within 14 days prior to sub-study registration. Patient must have fully recovered from the effects of prior surgery in the opinion of the treating investigator

    • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia

    • Patients must not have a QT interval by Fridericia (QTcF) > 470 msec based on the electrocardiogram (ECG) within 28 days prior to registration. It is suggested that a local cardiologist review the QTcF intervals

    • Patients must not have any clinically significant uncontrolled systemic illness, including but not limited to uncontrolled infection, requiring intravenous antibiotics, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmias, uncontrolled hypertension, or uncontrolled diabetes mellitus

    • Uncontrolled diabetes: Patients who have a diagnosis of diabetes must have an hemoglobin (Hb) A1C < 7% within 28 days prior to registration. The same criterion will be used in patients with confirmed diagnosis of diabetes mellitus who have been on a stable dietary or therapeutic regimen for this condition in the last three months

    • Uncontrolled blood pressure and hypertension: All blood pressure measurements within the 28 days prior to registration must be systolic blood pressure (SBP) =< 180 and diastolic blood pressure (DBP) =< 100. An exception can be made by a healthcare provider for a patient with a single blood pressure elevation who upon rechecking has a blood pressure within the parameters above

    • Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of LOXO-292 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease)

    • Patients must not be planning to receive any strong inhibitors or inducers of CYP3A4 at least 14 days prior to sub-study registration and throughout protocol treatment

    • Patients must not be planning to use proton pump inhibitors (PPIs) at least one week prior to sub-study registration and throughout protocol treatment

    • Patients must not be pregnant or nursing. Women study patients of reproductive potential and fertile men study patients and their partners must abstain or use effective contraception (including barrier method) while receiving study treatment and for at least 3 months after the last dose of LOXO-292. Male study patients must agree not to donate sperm for 6 months after the last dose of LOXO-292. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
    2 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    3 Kaiser Permanente-Anaheim Anaheim California United States 92806
    4 Sutter Auburn Faith Hospital Auburn California United States 95602
    5 Kaiser Permanente-Baldwin Park Baldwin Park California United States 91706
    6 Kaiser Permanente-Bellflower Bellflower California United States 90706
    7 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    8 Kaiser Permanente-Fontana Fontana California United States 92335
    9 Palo Alto Medical Foundation-Fremont Fremont California United States 94538
    10 Kaiser Permanente - Harbor City Harbor City California United States 90710
    11 Kaiser Permanente-Irvine Irvine California United States 92618
    12 Loma Linda University Medical Center Loma Linda California United States 92354
    13 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
    14 Kaiser Permanente-Cadillac Los Angeles California United States 90034
    15 Palo Alto Medical Foundation-Camino Division Mountain View California United States 94040
    16 Kaiser Permanente-Ontario Ontario California United States 91761
    17 Palo Alto Medical Foundation Health Care Palo Alto California United States 94301
    18 Stanford Cancer Institute Palo Alto Palo Alto California United States 94304
    19 Kaiser Permanente - Panorama City Panorama City California United States 91402
    20 Kaiser Permanente-Riverside Riverside California United States 92505
    21 Sutter Roseville Medical Center Roseville California United States 95661
    22 Sutter Medical Center Sacramento Sacramento California United States 95816
    23 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    24 Kaiser Permanente-San Diego Zion San Diego California United States 92120
    25 California Pacific Medical Center-Pacific Campus San Francisco California United States 94115
    26 Kaiser Permanente-San Marcos San Marcos California United States 92078
    27 Palo Alto Medical Foundation-Santa Cruz Santa Cruz California United States 95065
    28 Palo Alto Medical Foundation-Sunnyvale Sunnyvale California United States 94086
    29 Sutter Solano Medical Center/Cancer Center Vallejo California United States 94589
    30 Presbyterian Intercommunity Hospital Whittier California United States 90602
    31 Kaiser Permanente-Woodland Hills Woodland Hills California United States 91367
    32 University of Colorado Hospital Aurora Colorado United States 80045
    33 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    34 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    35 Memorial Hospital North Colorado Springs Colorado United States 80920
    36 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
    37 Poudre Valley Hospital Fort Collins Colorado United States 80524
    38 Cancer Care and Hematology-Fort Collins Fort Collins Colorado United States 80528
    39 North Colorado Medical Center Greeley Colorado United States 80631
    40 UCHealth Greeley Hospital Greeley Colorado United States 80631
    41 UCHealth Highlands Ranch Hospital Highlands Ranch Colorado United States 80129
    42 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    43 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
    44 UCHealth Lone Tree Health Center Lone Tree Colorado United States 80124
    45 Medical Center of the Rockies Loveland Colorado United States 80538
    46 McKee Medical Center Loveland Colorado United States 80539
    47 Hartford Hospital Hartford Connecticut United States 06102
    48 Veterans Affairs Connecticut Healthcare System-West Haven Campus West Haven Connecticut United States 06516
    49 Bayhealth Hospital Kent Campus Dover Delaware United States 19901
    50 Bayhealth Hospital Sussex Campus Milford Delaware United States 19963
    51 Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida United States 33180
    52 Mount Sinai Medical Center Miami Beach Florida United States 33140
    53 Moffitt Cancer Center Tampa Florida United States 33612
    54 Northside Hospital Atlanta Georgia United States 30342
    55 Northeast Georgia Medical Center Braselton Braselton Georgia United States 30517
    56 Atlanta VA Medical Center Decatur Georgia United States 30033
    57 Northside Hospital - Duluth Duluth Georgia United States 30096
    58 Northeast Georgia Medical Center-Gainesville Gainesville Georgia United States 30501
    59 Northside Hospital - Gwinnett Lawrenceville Georgia United States 30046
    60 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    61 Suburban Hematology Oncology Associates - Snellville Snellville Georgia United States 30078
    62 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    63 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    64 Hawaii Cancer Care Inc-POB II Honolulu Hawaii United States 96813
    65 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    66 Queen's Medical Center Honolulu Hawaii United States 96813
    67 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    68 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    69 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
    70 Saint Luke's Cancer Institute - Fruitland Fruitland Idaho United States 83619
    71 Saint Luke's Cancer Institute - Meridian Meridian Idaho United States 83642
    72 Saint Luke's Cancer Institute - Nampa Nampa Idaho United States 83686
    73 Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho United States 83301
    74 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    75 Illinois CancerCare-Canton Canton Illinois United States 61520
    76 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    77 Northwestern University Chicago Illinois United States 60611
    78 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
    79 Illinois CancerCare-Dixon Dixon Illinois United States 61021
    80 Crossroads Cancer Center Effingham Illinois United States 62401
    81 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    82 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois United States 60201
    83 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    84 NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois United States 60026
    85 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois United States 60035
    86 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    87 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    88 Loyola University Medical Center Maywood Illinois United States 60153
    89 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
    90 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    91 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    92 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    93 Illinois CancerCare-Peru Peru Illinois United States 61354
    94 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    95 Genesis Cancer Center - Silvis Silvis Illinois United States 61282
    96 Parkview Regional Medical Center Fort Wayne Indiana United States 46845
    97 Goshen Center for Cancer Care Goshen Indiana United States 46526
    98 Franciscan Health Indianapolis Indianapolis Indiana United States 46237
    99 Franciscan Health Mooresville Mooresville Indiana United States 46158
    100 Memorial Hospital of South Bend South Bend Indiana United States 46601
    101 Mary Greeley Medical Center Ames Iowa United States 50010
    102 McFarland Clinic PC - Ames Ames Iowa United States 50010
    103 McFarland Clinic PC-Boone Boone Iowa United States 50036
    104 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    105 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    106 Greater Regional Medical Center Creston Iowa United States 50801
    107 Genesis Medical Center - East Campus Davenport Iowa United States 52803
    108 Genesis Cancer Care Institute Davenport Iowa United States 52804
    109 Iowa Cancer Specialists Davenport Iowa United States 52807
    110 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    111 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    112 McFarland Clinic PC-Trinity Cancer Center Fort Dodge Iowa United States 50501
    113 McFarland Clinic PC-Jefferson Jefferson Iowa United States 50129
    114 McFarland Clinic PC-Marshalltown Marshalltown Iowa United States 50158
    115 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    116 HaysMed University of Kansas Health System Hays Kansas United States 67601
    117 University of Kansas Cancer Center Kansas City Kansas United States 66160
    118 Olathe Health Cancer Center Olathe Kansas United States 66061
    119 University of Kansas Cancer Center-Overland Park Overland Park Kansas United States 66210
    120 Salina Regional Health Center Salina Kansas United States 67401
    121 University of Kansas Health System Saint Francis Campus Topeka Kansas United States 66606
    122 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    123 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    124 Medical Center of Baton Rouge Baton Rouge Louisiana United States 70816
    125 Ochsner High Grove Baton Rouge Louisiana United States 70836
    126 Ochsner Medical Center Kenner Kenner Louisiana United States 70065
    127 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    128 Harold Alfond Center for Cancer Care Augusta Maine United States 04330
    129 Waldo County General Hospital Belfast Maine United States 04915
    130 MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine United States 04005
    131 Penobscot Bay Medical Center Rockport Maine United States 04856
    132 MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine United States 04073
    133 Maine Medical Partners - South Portland South Portland Maine United States 04106
    134 Western Maryland Regional Medical Center Cumberland Maryland United States 21502
    135 UMass Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    136 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    137 Bronson Battle Creek Battle Creek Michigan United States 49017
    138 IHA Hematology Oncology Consultants-Brighton Brighton Michigan United States 48114
    139 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    140 IHA Hematology Oncology Consultants-Canton Canton Michigan United States 48188
    141 Saint Joseph Mercy Canton Canton Michigan United States 48188
    142 IHA Hematology Oncology Consultants-Chelsea Chelsea Michigan United States 48118
    143 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    144 Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan United States 48038
    145 Henry Ford Hospital Detroit Michigan United States 48202
    146 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
    147 Genesee Hematology Oncology PC Flint Michigan United States 48503
    148 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    149 Spectrum Health at Butterworth Campus Grand Rapids Michigan United States 49503
    150 Allegiance Health Jackson Michigan United States 49201
    151 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    152 Sparrow Hospital Lansing Michigan United States 48912
    153 Hope Cancer Clinic Livonia Michigan United States 48154
    154 Saint Mary Mercy Hospital Livonia Michigan United States 48154
    155 Spectrum Health Reed City Hospital Reed City Michigan United States 49677
    156 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    157 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    158 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    159 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    160 Munson Medical Center Traverse City Michigan United States 49684
    161 Metro Health Hospital Wyoming Michigan United States 49519
    162 IHA Hematology Oncology Consultants-Ann Arbor Ypsilanti Michigan United States 48197
    163 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    164 Essentia Health - Deer River Clinic Deer River Minnesota United States 56636
    165 Essentia Health Cancer Center Duluth Minnesota United States 55805
    166 Essentia Health Hibbing Clinic Hibbing Minnesota United States 55746
    167 Minneapolis VA Medical Center Minneapolis Minnesota United States 55417
    168 United Hospital Saint Paul Minnesota United States 55102
    169 Essentia Health Sandstone Sandstone Minnesota United States 55072
    170 Essentia Health Virginia Clinic Virginia Minnesota United States 55792
    171 University of Mississippi Medical Center Jackson Mississippi United States 39216
    172 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    173 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    174 Parkland Health Center - Farmington Farmington Missouri United States 63640
    175 Truman Medical Centers Kansas City Missouri United States 64108
    176 University of Kansas Cancer Center - North Kansas City Missouri United States 64154
    177 University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri United States 64064
    178 University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri United States 64116
    179 Washington University School of Medicine Saint Louis Missouri United States 63110
    180 Mercy Hospital South Saint Louis Missouri United States 63128
    181 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    182 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    183 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    184 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    185 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    186 Mercy Hospital Springfield Springfield Missouri United States 65804
    187 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    188 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
    189 Community Hospital of Anaconda Anaconda Montana United States 59711
    190 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    191 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    192 OptumCare Cancer Care at Oakey Las Vegas Nevada United States 89102
    193 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    194 Renown Regional Medical Center Reno Nevada United States 89502
    195 New Hampshire Oncology Hematology PA-Concord Concord New Hampshire United States 03301
    196 Solinsky Center for Cancer Care Manchester New Hampshire United States 03103
    197 Virtua Samson Cancer Center Moorestown New Jersey United States 08057
    198 Virtua Voorhees Voorhees New Jersey United States 08043
    199 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    200 New Mexico Oncology Hematology Consultants Albuquerque New Mexico United States 87109
    201 Presbyterian Kaseman Hospital Albuquerque New Mexico United States 87110
    202 Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho New Mexico United States 87124
    203 James J Peters VA Medical Center Bronx New York United States 10468
    204 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
    205 Arnot Ogden Medical Center/Falck Cancer Center Elmira New York United States 14905
    206 University of Rochester Rochester New York United States 14642
    207 Randolph Hospital Asheboro North Carolina United States 27203
    208 Cone Health Cancer Center at Alamance Regional Burlington North Carolina United States 27215
    209 Rex Hematology Oncology Associates-Cary Cary North Carolina United States 27518
    210 Durham VA Medical Center Durham North Carolina United States 27705
    211 Rex Hematology Oncology Associates-Garner Garner North Carolina United States 27529
    212 Cone Health Cancer Center Greensboro North Carolina United States 27403
    213 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    214 Rex Cancer Center Raleigh North Carolina United States 27607
    215 Rex Hematology Oncology Associates-Blue Ridge Raleigh North Carolina United States 27607
    216 Rex Cancer Center of Wakefield Raleigh North Carolina United States 27614
    217 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    218 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    219 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    220 UHHS-Chagrin Highlands Medical Center Beachwood Ohio United States 44122
    221 Strecker Cancer Center-Belpre Belpre Ohio United States 45714
    222 Geauga Hospital Chardon Ohio United States 44024
    223 Adena Regional Medical Center Chillicothe Ohio United States 45601
    224 Case Western Reserve University Cleveland Ohio United States 44106
    225 Columbus Oncology and Hematology Associates Inc Columbus Ohio United States 43214
    226 Grant Medical Center Columbus Ohio United States 43215
    227 The Mark H Zangmeister Center Columbus Ohio United States 43219
    228 Doctors Hospital Columbus Ohio United States 43228
    229 Delaware Health Center-Grady Cancer Center Delaware Ohio United States 43015
    230 Marietta Memorial Hospital Marietta Ohio United States 45750
    231 OhioHealth Marion General Hospital Marion Ohio United States 43302
    232 UH Seidman Cancer Center at Landerbrook Health Center Mayfield Heights Ohio United States 44124
    233 UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio United States 44060
    234 UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio United States 44130
    235 Licking Memorial Hospital Newark Ohio United States 43055
    236 University Hospitals Parma Medical Center Parma Ohio United States 44129
    237 Southern Ohio Medical Center Portsmouth Ohio United States 45662
    238 University Hospitals Portage Medical Center Ravenna Ohio United States 44266
    239 UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio United States 44870
    240 ProMedica Flower Hospital Sylvania Ohio United States 43560
    241 University Hospitals Sharon Health Center Wadsworth Ohio United States 44281
    242 UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio United States 44145
    243 UHHS-Westlake Medical Center Westlake Ohio United States 44145
    244 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    245 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    246 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    247 Kaiser Permanente Northwest Portland Oregon United States 97227
    248 Oregon Health and Science University Portland Oregon United States 97239
    249 Salem Hospital Salem Oregon United States 97301
    250 Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton Pennsylvania United States 19401
    251 Ephrata Cancer Center Ephrata Pennsylvania United States 17522
    252 Adams Cancer Center Gettysburg Pennsylvania United States 17325
    253 Cherry Tree Cancer Center Hanover Pennsylvania United States 17331
    254 UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania United States 17109
    255 Sechler Family Cancer Center Lebanon Pennsylvania United States 17042
    256 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    257 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    258 Temple University Hospital Philadelphia Pennsylvania United States 19140
    259 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    260 Pottstown Hospital Pottstown Pennsylvania United States 19464
    261 UPMC Susquehanna Williamsport Pennsylvania United States 17701
    262 WellSpan Health-York Cancer Center York Pennsylvania United States 17403
    263 Medical University of South Carolina Charleston South Carolina United States 29425
    264 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    265 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    266 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    267 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    268 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    269 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    270 Prisma Health Cancer Institute - Spartanburg Spartanburg South Carolina United States 29307
    271 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
    272 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
    273 The Don and Sybil Harrington Cancer Center Amarillo Texas United States 79106
    274 Parkland Memorial Hospital Dallas Texas United States 75235
    275 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    276 Bon Secours Memorial Regional Medical Center Mechanicsville Virginia United States 23116
    277 Bon Secours Saint Francis Medical Center Midlothian Virginia United States 23114
    278 Bon Secours Saint Mary's Hospital Richmond Virginia United States 23226
    279 Jefferson Healthcare Port Townsend Washington United States 98368
    280 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
    281 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
    282 Duluth Clinic Ashland Ashland Wisconsin United States 54806
    283 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    284 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    285 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    286 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    287 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    288 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    289 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    290 Aspirus Medford Hospital Medford Wisconsin United States 54451
    291 Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin United States 53051
    292 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    293 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    294 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    295 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    296 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    297 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    298 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    299 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    300 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    301 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
    302 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    303 Aurora West Allis Medical Center West Allis Wisconsin United States 53227
    304 Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin United States 53095
    305 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    306 Aspirus UW Cancer Center Wisconsin Rapids Wisconsin United States 54494

    Sponsors and Collaborators

    • Southwest Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Yasir Y Elamin, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Southwest Oncology Group
    ClinicalTrials.gov Identifier:
    NCT04268550
    Other Study ID Numbers:
    • S1900B
    • NCI-2019-08097
    • S1900B
    • S1900B
    • U10CA180888
    First Posted:
    Feb 13, 2020
    Last Update Posted:
    Jul 7, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 7, 2022