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Testing the Addition of the Drug Atezolizumab to the Usual Radiation Treatment for Patients With Early Non-small Cell Lung Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04214262
Collaborator
(none)
480
Enrollment
268
Locations
2
Arms
97.2
Anticipated Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This phase III trial studies how well atezolizumab added to the usual radiation therapy works in treating patients with stage I-IIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy, such as stereotactic body radiation therapy, uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving atezolizumab and radiation therapy may work better than radiation therapy alone in treating patients with early non-small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: Atezolizumab
  • Procedure: Biospecimen Collection
  • Other: Quality-of-Life Assessment
  • Other: Questionnaire Administration
  • Radiation: Stereotactic Body Radiation Therapy
 Phase 3

Detailed Description

PRIMARY OBJECTIVE:
  1. To compare overall survival (OS) in patients with inoperable, early stage non-small cell lung cancer (NSCLC) randomized to stereotactic body radiation therapy (SBRT) with or without atezolizumab.
SECONDARY OBJECTIVES:

  1. To compare investigator-assessed progression-free survival (IA-PFS) between the arms.

  2. To compare progression free survival (PFS) by blinded independent centralized review (BIRC) between the arms in a random subset of patients.

  3. To evaluate distant, locoregional, and local failure rates within each treatment arm.

  4. To evaluate the frequency and severity of toxicities within each treatment arm.

ADDITIONAL OBJECTIVE:
  1. To collect specimens for banking.
HEALTH-RELATED QUALITY OF LIFE (HRQOL) OBJECTIVE:
  1. To assess quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)-30 and EORTC-QLQ- Lung Cancer (LC)13 between the arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days over 1-3 weeks. Patients also undergo collection of blood samples after randomization prior to treatment, one week after completion of SBRT, at week 18, and then at disease progression.

ARM B: Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days over 1-3 weeks. Patients also undergo collection of blood samples after randomization prior to treatment, one week after completion of SBRT, at week 18, and then at disease progression.

After completion of study treatment, patients are followed up at weeks 18, 30, 42, and 54, every 6 months for 2 years, and then every 12 months for 2 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC
Actual Study Start Date :
Mar 25, 2020
Anticipated Primary Completion Date :
May 1, 2028
Anticipated Study Completion Date :
May 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A (atezolizumab, SBRT)

Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1 cycle 3, patients also undergo SBRT for 3-8 treatments every 2 days over 1-3 weeks. Patients also undergo collection of blood samples after randomization prior to treatment, one week after completion of SBRT, at week 18, and then at disease progression.

Drug: Atezolizumab
Given IV
Other Names:
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL3280A
  • MPDL328OA
  • RG7446
  • RO5541267
  • Tecentriq

    • Procedure: Biospecimen Collection
    Undergo collection of blood samples
    Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Radiation: Stereotactic Body Radiation Therapy
    Undergo SBRT
    Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

    		•
    Active Comparator: Arm B (SBRT)

    Beginning 21 days after randomization, patients undergo SBRT for 3-8 treatments every 2 days over 1-3 weeks. Patients also undergo collection of blood samples after randomization prior to treatment, one week after completion of SBRT, at week 18, and then at disease progression.

    Procedure: Biospecimen Collection
    Undergo collection of blood samples
    Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    • Other: Questionnaire Administration
    Ancillary studies

    Radiation: Stereotactic Body Radiation Therapy
    Undergo SBRT
    Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [From date of randomization to date of death due to any cause, assessed up to 3 years]

      Will compare overall survival between patients with inoperable, T1, T2, limited T3, N0M0 (early stage) non-small cell lung cancer randomized to stereotactic body radiation therapy with or without atezolizumab. Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.

    Secondary Outcome Measures

    1. Progression free survival [From date of randomization to date of first documentation of progression or death due to any cause, assessed up to 5 years]

      Will be evaluated using the method of Kaplan-Meier. For point estimates at landmark times, the associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios for these outcomes will be estimated using a Cox Proportional Hazards regression model and estimated using a stratified Cox regression model.

    2. Incidence of adverse events [Up to 5 years]

      This study will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for toxicity and serious adverse event reporting.

    Other Outcome Measures

    1. Change in health-related quality of life [Up to 5 years]

      As measured by the EORTC Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EORTC-QLQ-LC13, between arms. The scores at baseline and subsequent time points, as well the changes from baseline at each time point for each treatment group will be analyzed as continuous variables and compared using the two-sample t-test.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient must have histologically or cytologically proven stage I-IIA or limited T3N0M0 non-small cell lung cancer (NSCLC), without radiographic evidence of nodal or distant involvement (N0M0). Patient may have T3 disease with the exclusion of pericardial involvement. Patients with multifocal tumors with no more than two lesions confirmed or suspected to be synchronous early stage NSCLCs are eligible provided at least one lesion is histologically or cytologically proven to be NSCLC and meets one or more high-risk features

    • Disease must have one or more of the following high-risk features:

    • Tumor diameter >= 2 cm (inclusive of any non-solid, ground glass component) as assessed by diagnostic computed tomography CT

    • Tumor standard uptake value (SUV) max >= 6.2 as assessed by fludeoxyglucose F-18 (FDG) positron emission tomography (PET)/CT

    • Moderately differentiated, poorly differentiated, or undifferentiated histology

    • Patient must have undergone diagnostic chest CT with or without contrast (IV contrast preferred) within 42 days prior to randomization. PET-CT may be used if the CT portion is of comparable diagnostic quality to a stand-alone CT. All disease must be assessed within 42 days prior to randomization

    • Patient must have undergone FDG PET/CT of chest within 90 days prior to randomization

    • Patient must have undergone history and physical examination within 28 days prior to randomization

    • Patient must be medically or surgically inoperable as documented by a board certified thoracic surgeon or multi-disciplinary tumor board consensus OR patient's unwillingness to undergo surgical resection must be clearly documented

    • Patient must be >= 18 years old

    • Patient must have Zubrod performance status of 0-2

    • Patient must have adequate liver function defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper level of normal (IULN) within 28 days prior to randomization

    • Patient must have adequate renal function defined as calculated creatinine clearance

    = 30 mL/min using the following formula. The serum creatinine value used in the calculation must have been collected within 28 days prior to randomization

    • Patient must have absolute neutrophil count (ANC), platelets, and hemoglobin measured within 28 days prior to randomization. The purpose of these tests is to collect baseline values to compare with on-treatment values

    • Patient must have thyroid-stimulating hormone (TSH) measured within 28 days prior to randomization. The purpose of this test is to collect baseline values to compare with on-treatment values

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

    • 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 randomization

    • Patient must have pulmonary function testing documented within 90 days prior to randomization

    • Patients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to randomization

    • Patient must not have a history of clinically significant interstitial lung disease or evidence of active pneumonitis on the screening chest CT

    • Patients must not have a prior or concurrent malignancy whose natural history or treatment has the potential (in the opinion of the treating physician) to interfere with the safety or efficacy assessment of the investigational regimen

    • Patients must not be pregnant due to the potential teratogenic side effects of the protocol treatment. Women of reproductive potential and men must have agreed to use an effective contraception method for the duration of protocol treatment, and for 5 months (150 days) after the last dose of atezolizumab. A woman is considered to be of "reproductive potential" if she has had a 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. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab, breastfeeding must be discontinued prior to randomization

    • Patients of reproductive potential must have a negative serum pregnancy test within 14 days prior to randomization

    • Patient must agree to have specimens submitted for translational medicine and banking

    • 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 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 who can complete quality of life instruments in English, French, or Spanish must agree to complete the questionnaires at the protocol-specified time points

    Exclusion Criteria:

    • Patient must not have evidence of hilar or mediastinal nodal involvement. Any patient with radiographically suspicious hilar or mediastinal nodes (including features such as non-calcified nodes with a short axis diameter > 1 cm, abnormal morphology, and/or elevated FDG avidity) must undergo cytologic sampling of suspicious nodes to rule out involvement prior to randomization. Mediastinal nodal sampling for other patients is optional. For cases in which the treating physician/multidisciplinary opinion is used to define nodes as "non-suspicious" (such as long-standing, stable enlarged nodes from other medical causes), the rationale must be clearly documented within the medical record

    • Patient must not have received any prior treatment for the current NSCLC diagnosis

    • Patient must not have undergone prior radiation to overlapping regions of the chest that, in the opinion of the treatment physician, will interfere with protocol treatment

    • Patient must not have received treatment with systemic immunostimulatory or immunosuppressive agents, including corticosteroids, within 14 days prior to randomization

    • Patient must not have significant cardiovascular disease (New York Heart Association [NYHA] class II or greater)

    • Patient must not have myocardial infarction within 90 days prior to randomization

    • Patient must not have unstable arrhythmias or unstable angina

    • Patient must not have known left ventricular ejection fraction (LVEF) < 40% within 28 days prior to randomization

    • NOTE: Assessment of LVEF by echocardiogram or multigated acquisition (MUGA) is not an eligibility requirement, but if a standard of care echocardiogram or MUGA was clinically indicated, the LVEF must not be < 40% within 28 days prior to randomization

    • Patient must not have had an infection >= grade 3 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) within 28 days prior to randomization

    • Patient must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed

    • Patients must not have known active tuberculosis

    • Patients must not have received a live, attenuated vaccine within 28 days prior to randomization

    • NOTE: All Coronavirus disease 2019 (COVID-19) vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable

    • Patients must not have a known history of allergic reactions attributed to compounds of similar chemical or biologic composition to atezolizumab

    • Patients must not have a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Alaska Medical Center Anchorage Alaska United States 99508
    2 NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas United States 72401
    3 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    4 Alta Bates Summit Medical Center-Herrick Campus Berkeley California United States 94704
    5 Loma Linda University Medical Center Loma Linda California United States 92354
    6 Veterans Affairs Loma Linda Healthcare System Loma Linda California United States 92357
    7 Tibor Rubin VA Medical Center Long Beach California United States 90822
    8 Los Angeles County-USC Medical Center Los Angeles California United States 90033
    9 USC / Norris Comprehensive Cancer Center Los Angeles California United States 90033
    10 Fremont - Rideout Cancer Center Marysville California United States 95901
    11 Saint Joseph Hospital - Orange Orange California United States 92868
    12 UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California United States 92868
    13 Desert Regional Medical Center Palm Springs California United States 92262
    14 Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California United States 95661
    15 Sutter Roseville Medical Center Roseville California United States 95661
    16 Sutter Medical Center Sacramento Sacramento California United States 95816
    17 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    18 California Pacific Medical Center-Pacific Campus San Francisco California United States 94115
    19 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California United States 96161
    20 Presbyterian Intercommunity Hospital Whittier California United States 90602
    21 Rocky Mountain Regional VA Medical Center Aurora Colorado United States 80045
    22 University of Colorado Hospital Aurora Colorado United States 80045
    23 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
    24 UCHealth Memorial Hospital Central Colorado Springs Colorado United States 80909
    25 Memorial Hospital North Colorado Springs Colorado United States 80920
    26 Kaiser Permanente-Franklin Denver Colorado United States 80205
    27 Poudre Valley Hospital Fort Collins Colorado United States 80524
    28 Cancer Care and Hematology-Fort Collins Fort Collins Colorado United States 80528
    29 North Colorado Medical Center Greeley Colorado United States 80631
    30 UCHealth Greeley Hospital Greeley Colorado United States 80631
    31 Kaiser Permanente-Rock Creek Lafayette Colorado United States 80026
    32 Kaiser Permanente-Lone Tree Lone Tree Colorado United States 80124
    33 Medical Center of the Rockies Loveland Colorado United States 80538
    34 McKee Medical Center Loveland Colorado United States 80539
    35 Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut United States 06830
    36 Smilow Cancer Hospital Care Center - Guiford Guilford Connecticut United States 06437
    37 Smilow Cancer Hospital-Hamden Care Center Hamden Connecticut United States 06518
    38 Yale University New Haven Connecticut United States 06520
    39 Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut United States 06611
    40 Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut United States 06385
    41 Bayhealth Hospital Kent Campus Dover Delaware United States 19901
    42 Beebe South Coastal Health Campus Frankford Delaware United States 19945
    43 Helen F Graham Cancer Center Newark Delaware United States 19713
    44 Medical Oncology Hematology Consultants PA Newark Delaware United States 19713
    45 Beebe Health Campus Rehoboth Beach Delaware United States 19971
    46 GenesisCare USA - Aventura FP Aventura Florida United States 33180
    47 GenesisCare USA - Aventura Aventura Florida United States 33180
    48 GenesisCare USA - Plantation Plantation Florida United States 33324
    49 Florida Cancer Specialists - Sarasota Sarasota Florida United States 34232
    50 Florida Cancer Specialists - Sarasota Downtown Sarasota Florida United States 34236
    51 Sarasota Memorial Hospital Sarasota Florida United States 34239
    52 Sarasota Memorial Health Care Center at University Parkway Sarasota Florida United States 34243
    53 Augusta University Medical Center Augusta Georgia United States 30912
    54 Memorial Health University Medical Center Savannah Georgia United States 31404
    55 Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia United States 31405
    56 Hawaii Cancer Care - Savio 'Aiea Hawaii United States 96701
    57 Pali Momi Medical Center 'Aiea Hawaii United States 96701
    58 Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii United States 96813
    59 Queen's Cancer Cenrer - POB I Honolulu Hawaii United States 96813
    60 Queen's Medical Center Honolulu Hawaii United States 96813
    61 Straub Clinic and Hospital Honolulu Hawaii United States 96813
    62 Queen's Cancer Center - Kuakini Honolulu Hawaii United States 96817
    63 The Cancer Center of Hawaii-Liliha Honolulu Hawaii United States 96817
    64 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    65 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    66 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    67 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
    68 Illinois CancerCare-Canton Canton Illinois United States 61520
    69 Illinois CancerCare-Carthage Carthage Illinois United States 62321
    70 University of Illinois Chicago Illinois United States 60612
    71 Decatur Memorial Hospital Decatur Illinois United States 62526
    72 Crossroads Cancer Center Effingham Illinois United States 62401
    73 Illinois CancerCare-Eureka Eureka Illinois United States 61530
    74 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
    75 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
    76 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
    77 Illinois CancerCare-Macomb Macomb Illinois United States 61455
    78 Loyola University Medical Center Maywood Illinois United States 60153
    79 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
    80 Illinois CancerCare-Pekin Pekin Illinois United States 61554
    81 Illinois CancerCare-Peoria Peoria Illinois United States 61615
    82 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    83 OSF Saint Francis Medical Center Peoria Illinois United States 61637
    84 Illinois CancerCare-Peru Peru Illinois United States 61354
    85 Illinois CancerCare-Princeton Princeton Illinois United States 61356
    86 SwedishAmerican Regional Cancer Center/ACT Rockford Illinois United States 61114
    87 Springfield Clinic Springfield Illinois United States 62702
    88 Memorial Medical Center Springfield Illinois United States 62781
    89 Carle Cancer Center Urbana Illinois United States 61801
    90 McFarland Clinic PC - Ames Ames Iowa United States 50010
    91 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
    92 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
    93 Greater Regional Medical Center Creston Iowa United States 50801
    94 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
    95 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
    96 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
    97 LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana United States 70805
    98 Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana United States 70809
    99 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    100 Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana United States 70809
    101 Mary Bird Perkins Cancer Center - Houma Houma Louisiana United States 70360
    102 Terrebonne General Medical Center Houma Louisiana United States 70360
    103 UM Saint Joseph Medical Center Towson Maryland United States 21204
    104 Beverly Hospital Beverly Massachusetts United States 01915
    105 Lahey Hospital and Medical Center Burlington Massachusetts United States 01805
    106 Addison Gilbert Hospital Gloucester Massachusetts United States 01930
    107 Winchester Hospital Winchester Massachusetts United States 01890
    108 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
    109 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
    110 Saint Joseph Mercy Canton Canton Michigan United States 48188
    111 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
    112 GenesisCare USA - Clarkston Clarkston Michigan United States 48346
    113 Beaumont Hospital - Dearborn Dearborn Michigan United States 48124
    114 Ascension Saint John Hospital Detroit Michigan United States 48236
    115 GenesisCare USA - Farmington Hills Farmington Hills Michigan United States 48334
    116 Beaumont Hospital - Farmington Hills Farmington Hills Michigan United States 48336
    117 Genesys Hurley Cancer Institute Flint Michigan United States 48503
    118 West Michigan Cancer Center Kalamazoo Michigan United States 49007
    119 Sparrow Hospital Lansing Michigan United States 48912
    120 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
    121 GenesisCare USA - Macomb Macomb Michigan United States 48044
    122 Ascension Providence Hospitals - Novi Novi Michigan United States 48374
    123 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
    124 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
    125 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
    126 Lakeland Medical Center Saint Joseph Saint Joseph Michigan United States 49085
    127 Marie Yeager Cancer Center Saint Joseph Michigan United States 49085
    128 Ascension Providence Hospitals - Southfield Southfield Michigan United States 48075
    129 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
    130 Munson Medical Center Traverse City Michigan United States 49684
    131 GenesisCare USA - Troy Troy Michigan United States 48098
    132 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
    133 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
    134 Metro Health Hospital Wyoming Michigan United States 49519
    135 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
    136 Miller-Dwan Hospital Duluth Minnesota United States 55805
    137 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    138 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
    139 Regions Hospital Saint Paul Minnesota United States 55101
    140 Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi United States 39705
    141 Baptist Cancer Center-Grenada Grenada Mississippi United States 38901
    142 University of Mississippi Medical Center Jackson Mississippi United States 39216
    143 Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi United States 38652
    144 Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi United States 38655
    145 Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi United States 38671
    146 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
    147 Parkland Health Center - Farmington Farmington Missouri United States 63640
    148 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
    149 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
    150 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
    151 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
    152 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    153 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    154 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    155 Nebraska Medicine-Bellevue Bellevue Nebraska United States 68123
    156 CHI Health Saint Francis Grand Island Nebraska United States 68803
    157 CHI Health Good Samaritan Kearney Nebraska United States 68847
    158 Nebraska Medicine-Village Pointe Omaha Nebraska United States 68118
    159 University of Nebraska Medical Center Omaha Nebraska United States 68198
    160 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
    161 Cooper Hospital University Medical Center Camden New Jersey United States 08103
    162 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
    163 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
    164 Capital Health Medical Center-Hopewell Pennington New Jersey United States 08534
    165 MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey United States 08043
    166 University of New Mexico Cancer Center Albuquerque New Mexico United States 87102
    167 Roswell Park Cancer Institute Buffalo New York United States 14263
    168 Memorial Sloan Kettering Commack Commack New York United States 11725
    169 Cancer Institute at Saint Francis Hospital East Hills New York United States 11548
    170 Arnot Ogden Medical Center/Falck Cancer Center Elmira New York United States 14905
    171 Memorial Sloan Kettering Westchester Harrison New York United States 10604
    172 Mount Sinai Chelsea New York New York United States 10011
    173 Mount Sinai West New York New York United States 10019
    174 Mount Sinai Hospital New York New York United States 10029
    175 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    176 State University of New York Upstate Medical University Syracuse New York United States 13210
    177 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
    178 Good Samaritan Hospital Medical Center West Islip New York United States 11795
    179 Messino Cancer Centers Asheville North Carolina United States 28806
    180 Durham VA Medical Center Durham North Carolina United States 27705
    181 CaroMont Regional Medical Center Gastonia North Carolina United States 28054
    182 Margaret R Pardee Memorial Hospital Hendersonville North Carolina United States 28791
    183 Novant Health Cancer Institute - Kernersville Kernersville North Carolina United States 27284
    184 CarolinaEast Medical Center New Bern North Carolina United States 28561
    185 FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina United States 28374
    186 NHRMC Radiation Oncology - Supply Supply North Carolina United States 28462
    187 New Hanover Regional Medical Center/Zimmer Cancer Center Wilmington North Carolina United States 28401
    188 Novant Health Cancer Institute Radiation Oncology - Wilmington Wilmington North Carolina United States 28401
    189 Novant Health Forsyth Medical Center Winston-Salem North Carolina United States 27103
    190 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
    191 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    192 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
    193 MetroHealth Medical Center Cleveland Ohio United States 44109
    194 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    195 The Mark H Zangmeister Center Columbus Ohio United States 43219
    196 Mount Carmel Grove City Hospital Grove City Ohio United States 43123
    197 Saint Ann's Hospital Westerville Ohio United States 43081
    198 Genesis Healthcare System Cancer Care Center Zanesville Ohio United States 43701
    199 Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma United States 73505
    200 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    201 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
    202 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    203 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
    204 Legacy Good Samaritan Hospital and Medical Center Portland Oregon United States 97210
    205 Providence Portland Medical Center Portland Oregon United States 97213
    206 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    207 Geisinger Medical Center Danville Pennsylvania United States 17822
    208 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
    209 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
    210 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    211 Geisinger Cancer Services-Pottsville Pottsville Pennsylvania United States 17901
    212 Reading Hospital West Reading Pennsylvania United States 19611
    213 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
    214 Rhode Island Hospital Providence Rhode Island United States 02903
    215 McLeod Regional Medical Center Florence South Carolina United States 29506
    216 Saint Francis Hospital Greenville South Carolina United States 29601
    217 Saint Francis Cancer Center Greenville South Carolina United States 29607
    218 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
    219 Spartanburg Medical Center Spartanburg South Carolina United States 29303
    220 Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee United States 38017
    221 Ballad Health Cancer Care - Kingsport Kingsport Tennessee United States 37660
    222 Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee United States 37660
    223 Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee United States 38120
    224 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    225 George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City Utah United States 84148
    226 Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia United States 22939
    227 Southwest VA Regional Cancer Center Norton Virginia United States 24273
    228 Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington United States 98684
    229 Legacy Salmon Creek Hospital Vancouver Washington United States 98686
    230 West Virginia University Charleston Division Charleston West Virginia United States 25304
    231 Edwards Comprehensive Cancer Center Huntington West Virginia United States 25701
    232 Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia United States 26003
    233 ThedaCare Regional Cancer Center Appleton Wisconsin United States 54911
    234 Northwest Wisconsin Cancer Center Ashland Wisconsin United States 54806
    235 Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin United States 53045
    236 Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin United States 53105
    237 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    238 Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin United States 53132
    239 Aurora Health Care Germantown Health Center Germantown Wisconsin United States 53022
    240 Aurora Cancer Care-Grafton Grafton Wisconsin United States 53024
    241 Bellin Memorial Hospital Green Bay Wisconsin United States 54301
    242 Aurora BayCare Medical Center Green Bay Wisconsin United States 54311
    243 Aurora Cancer Care-Kenosha South Kenosha Wisconsin United States 53142
    244 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    245 Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin United States 54601
    246 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    247 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin United States 54143
    248 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    249 Ascension Columbia Saint Mary's Hospital Ozaukee Mequon Wisconsin United States 53097
    250 Aurora Cancer Care-Milwaukee Milwaukee Wisconsin United States 53209
    251 Ascension Columbia Saint Mary's Hospital - Milwaukee Milwaukee Wisconsin United States 53211
    252 Aurora Saint Luke's Medical Center Milwaukee Wisconsin United States 53215
    253 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233
    254 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    255 ProHealth D N Greenwald Center Mukwonago Wisconsin United States 53149
    256 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    257 Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin United States 54904
    258 Ascension All Saints Hospital Racine Wisconsin United States 53405
    259 Aurora Cancer Care-Racine Racine Wisconsin United States 53406
    260 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    261 Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin United States 53081
    262 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin United States 54482
    263 Aurora Medical Center in Summit Summit Wisconsin United States 53066
    264 Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin United States 54241
    265 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188
    266 Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa Wisconsin United States 53226
    267 Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin United States 53226
    268 Aurora West Allis Medical Center West Allis Wisconsin United States 53227

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Megan E Daly, Southwest Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04214262
    Other Study ID Numbers:
    • NCI-2019-08627
    • NCI-2019-08627
    • S1914
    • S1914
    • U10CA180888
    First Posted:
    Jan 2, 2020
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Atezolizumab
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Aug 25, 2022