Combination Treatment (Talazoparib Plus Avelumab) for Stage IV or Recurrent Non-Squamous Non-Small Cell Lung Cancer With STK11 Gene Mutation (A LUNG-MAP Treatment Trial)
Study Details
Study Description
Brief Summary
This phase II LUNG-MAP treatment trial studies how well combination treatment (talazoparib plus avelumab) works in treating patients with non-squamous non-small cell lung cancer that has an STK11 gene mutation and has come back (recurrent) or is stage IV. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunotherapy drugs given as single therapies or in combination with chemotherapy do not appear to work as well in lung cancer cells with mutations in the STK11 gene versus those that do not have the mutation. Adding the medicine talazoparib to the immunotherapy drug avelumab may work better in treating lung cancers that have an STK11 gene mutation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
PRIMARY OBJECTIVES:
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To evaluate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib plus avelumab in patients with stage IV or recurrent non-squamous non-small cell lung cancer bearing pathogenic STK11 genomic alterations that were previously-treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.
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To evaluate disease control rate at 12 weeks (DCR12) after registration.
SECONDARY OBJECTIVES:
- To evaluate investigator assessed progression-free survival (IA-PFS). II. To evaluate overall survival (OS). III. To evaluate duration of response (DOR) among responders. IV. To evaluate the frequency and severity of toxicities.
TRANSLATIONAL MEDICINE OBJECTIVES:
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To collect, process, and bank cell-free deoxyribonucleic acid (DNA) (cfDNA) at baseline, cycle 3 day 1, progression, and end of treatment for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA (ctDNA) and examine molecular mechanisms of resistance to talazoparib and avelumab.
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To establish a tissue/blood repository from patients with refractory non-small cell lung cancer (NSCLC).
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To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent somatic mutations in KEAP1 detected on the Foundation Medicine Inc. (FMI) panel from the LUNGMAP screening protocol.
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To evaluate clinical outcomes (ORR, IA-PFS, OS) in patients with concurrent mutations in ATM or other DNA damage response genes detected on the FMI panel from the LUNGMAP screening protocol.
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To evaluate the association between tumor mutational burden (TMB) measured on the FMI panel from the LUNGMAP screening protocol and clinical outcomes (ORR, IA-PFS, OS).
OUTLINE:
Patients receive talazoparib orally (PO) daily and avelumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up until death or 3 years after sub-study registration.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment (talazoparib, avelumab) Patients receive talazoparib PO daily and avelumab IV over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Drug: Avelumab
Given IV
Other Names:
Drug: Talazoparib
Given PO
Other Names:
Drug: Talazoparib Tosylate
Given PO
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Best objective response rate (ORR) [Up to 3 years]
Will be assessed by complete response (CR), unconfirmed CR (UCR), partial response (PR), and unconfirmed PR (UPR).
- Disease control rate [At 12 weeks after registration]
Will be defined as a best response of CR, PR, UPR, or UCR by/at the second disease assessment at 12 weeks after registration (+/- 2 weeks), or stable disease at 12 weeks after registration (+/- 2 weeks).
Secondary Outcome Measures
- Frequency and severity of toxicities [Up to 3 years]
Will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
- Progression free survival [From date of sub-study registration to date of first documentation of progression assessed by local review, central review, symptomatic deterioration, or death due to any cause, assessed up to 3 years]
Binary proportions and associated confidence intervals will be calculated. The method of Kaplan-Meier will be used to estimate survival distributions and the Brookmeyer-Crowley method will be used to estimate confidence intervals around medians.
- Overall survival [Up to 3 years]
Binary proportions and associated confidence intervals will be calculated. The method of Kaplan-Meier will be used to estimate survival distributions and the Brookmeyer-Crowley method will be used to estimate confidence intervals around medians.
- Duration of response [From date of first documentation of response (CR or PR) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among patients who achieve a response (CR or PR), up to 3 years]
Binary proportions and associated confidence intervals will be calculated. The method of Kaplan-Meier will be used to estimate survival distributions and the Brookmeyer-Crowley method will be used to estimate confidence intervals around medians.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients must be assigned to S1900C. Assignment to S1900C is determined by the LUNGMAP protocol genomic profiling using the FoundationOne assay. Biomarker eligibility for S1900C is based on the identification of a pathogenic somatic mutation in STK11 or STK11 bi-allelic loss on tumor
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Patients must have histologically or cytologically confirmed stage IV or recurrent non-squamous, mixed squamous/non-squamous (e.g., adeno-squamous carcinoma), or non-small cell lung cancer not otherwise specified (NSCLC NOS). Patients with pure squamous cell carcinoma are not eligible
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Patients with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to sub-study registration
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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 sub-study registration
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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 sub-study registration
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Patients must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for stage III, IV or recurrent disease. Any number of additional, non-platinum-based chemotherapy or targeted therapy regimens for recurrent or metastatic disease are allowed
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Patients may not have received more than one line of anti-PD-1 or anti-PD-L1 therapy in the Stage IV or recurrent setting. Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with platinum-based chemotherapy, an anti-CTLA4 therapy, or other immune-modulatory therapy. Patients must have experienced disease progression > 42 days following initiation (cycle 1 day 1) of the anti-PD-1 or anti-PD-L1 containing regimen
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Patients who did not receive anti-PD-1 or anti-PD-L1 therapy in combination with platinum-based chemotherapy, must have also received prior platinum-based chemotherapy and experienced disease progression > 42 days following initiation (cycle 1 day 1) of platinum based chemotherapy
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Patients who received anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy, are eligible if they experienced disease progression less than (<) 365 days from the date of initiation of anti-PD-1 or anti-PD-L1 therapy
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Patients who received prior adjuvant platinum-based therapy post-surgical resection for stage I-III disease (i.e. the patient has not received platinum-based chemotherapy for Stage IV or recurrent disease) must have had disease progression during or after platinum-based chemotherapy that occurred less than (<) 365 days from the last date that the patient received that therapy
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Patients must be able to swallow capsules whole
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Patients must not have had prior exposure to any agent with a PARP inhibitor (e.g., veliparib, olaparib, rucaparib, niraparib, talazoparib) as its primary pharmacology
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Patients must not be taking, nor plan to take while on protocol treatment strong P-glycoprotein (P-gp) inhibitors (e.g. dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), P-gp inducers (rifampin, ritonavir, tipranavir), or strong breast cancer resistance protein (BCRP) inhibitors (e.g. elacridar)
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Patients must have progressed following their most recent line of therapy
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Patients must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study registration. 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
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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
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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 sub-study registration. CT and MRI scans must be submitted for central review via Transfer of Images and Data (TRIAD)
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Patients must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study registration. 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 sub-study registration, AND (2) patient has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to sub-study registration
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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
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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
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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, either ALT or AST must be =< 5 x IULN (if both ALT and AST are done, both must be =< 5 x IULN)
-
Patients must have a serum creatinine =< the IULN or calculated creatinine clearance
= 50 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to sub-study registration
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Patients must have Zubrod performance status 0-1 documented within 28 days prior to sub-study registration
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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
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Pre-study history and physical exam must be obtained within 28 days prior to sub-study registration
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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
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Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
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Platelet count >= 100,000 mcl (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
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Hemoglobin >= 9 g/dL (obtained within 28 days prior to sub-study registration). Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to sub-study registration)
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Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA)
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Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens
Exclusion Criteria:
-
Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. 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
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Patients must not have a history of prior organ transplantation, including allogeneic stem-cell transplantation
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Patients must not have received systemic treatment with corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 7 days prior to sub-study registration. Inhaled or topical steroids, and adrenal replacement doses =< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
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Patients must not have active autoimmune disease that requires systemic steroids (equivalent of > 10 mg of prednisone) or immunosuppressive agents within 7 days prior to sub-study registration (for example disease-modifying anti-rheumatic drugs). Exceptions include: patients with controlled type 1 diabetes mellitus, controlled hypo- or hyperthyroidism, vitiligo, resolved childhood asthma/atopy, or psoriasis not requiring immunosuppressive therapy
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Patients must not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of talazoparib (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or active peptic ulcer disease). Patients must not have active small or large intestine inflammation such as Crohn's disease or ulcerative colitis within 12 months prior to sub-study registration
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Patients must not have known prior or suspected hypersensitivity to monoclonal antibodies (grade >= 3)
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Patients must not have any history of anaphylaxis or uncontrolled asthma. Uncontrolled asthma is defined as a patient having any one of the following criteria:
-
Poor symptom control: Asthma Control Questionnaire (ACQ) consistently > 1.5 or Asthma Control Test Questionnaire (ACT) < 20 (or "not well controlled" by National Asthma Education and Prevention Program [NAEPP] or Global Initiative for Asthma [GINA] guidelines over the 3 months or evaluation)
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Frequent severe exacerbations: 2 or more bursts of systemic corticosteroids (CSs) (> 3 days each) in the previous year
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Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year
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Airflow limitation: Forced expiratory volume in 1 second (FEV1) < 80% predicted (in the presence of reduced FEV1/forced vital capacity [FVC] defined as less than the normal lower limit) following a withhold of both short- and long-acting bronchodilators
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Patients must not have experienced any immune related adverse event, including pneumonitis that led to permanent discontinuation of prior immunotherapy and/or required prolonged high dose of steroids
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Patients must not have evidence of active infection requiring systemic therapy
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Patients must not have received any live attenuated vaccinations within 28 days prior to sub-study registration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Alabama Mitchell Cancer Institute | Mobile | Alabama | United States | 36688 |
| 2 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 3 | Kaiser Permanente-Anaheim | Anaheim | California | United States | 92806 |
| 4 | Kaiser Permanente-Baldwin Park | Baldwin Park | California | United States | 91706 |
| 5 | Kaiser Permanente-Bellflower | Bellflower | California | United States | 90706 |
| 6 | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | United States | 94704 |
| 7 | Kaiser Permanente-Fontana | Fontana | California | United States | 92335 |
| 8 | Palo Alto Medical Foundation-Fremont | Fremont | California | United States | 94538 |
| 9 | Kaiser Permanente-Fresno | Fresno | California | United States | 93720 |
| 10 | Kaiser Permanente - Harbor City | Harbor City | California | United States | 90710 |
| 11 | Kaiser Permanente-Irvine | Irvine | California | United States | 92618 |
| 12 | Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | United States | 90027 |
| 13 | Kaiser Permanente-Cadillac | Los Angeles | California | United States | 90034 |
| 14 | Palo Alto Medical Foundation-Camino Division | Mountain View | California | United States | 94040 |
| 15 | Kaiser Permanente-Oakland | Oakland | California | United States | 94611 |
| 16 | Palo Alto Medical Foundation Health Care | Palo Alto | California | United States | 94301 |
| 17 | Kaiser Permanente - Panorama City | Panorama City | California | United States | 91402 |
| 18 | Kaiser Permanente-Riverside | Riverside | California | United States | 92505 |
| 19 | Kaiser Permanente-Roseville | Roseville | California | United States | 95661 |
| 20 | Kaiser Permanente Downtown Commons | Sacramento | California | United States | 95814 |
| 21 | Sutter Medical Center Sacramento | Sacramento | California | United States | 95816 |
| 22 | University of California Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 23 | Kaiser Permanente-San Diego Zion | San Diego | California | United States | 92120 |
| 24 | California Pacific Medical Center-Pacific Campus | San Francisco | California | United States | 94115 |
| 25 | Kaiser Permanente-San Francisco | San Francisco | California | United States | 94115 |
| 26 | Kaiser Permanente-Santa Teresa-San Jose | San Jose | California | United States | 95119 |
| 27 | Kaiser Permanente San Leandro | San Leandro | California | United States | 94577 |
| 28 | Kaiser Permanente-San Marcos | San Marcos | California | United States | 92078 |
| 29 | Kaiser San Rafael-Gallinas | San Rafael | California | United States | 94903 |
| 30 | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | United States | 95051 |
| 31 | Palo Alto Medical Foundation-Santa Cruz | Santa Cruz | California | United States | 95065 |
| 32 | Kaiser Permanente-South San Francisco | South San Francisco | California | United States | 94080 |
| 33 | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California | United States | 94086 |
| 34 | Kaiser Permanente-Vallejo | Vallejo | California | United States | 94589 |
| 35 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
| 36 | Kaiser Permanente-Walnut Creek | Walnut Creek | California | United States | 94596 |
| 37 | Presbyterian Intercommunity Hospital | Whittier | California | United States | 90602 |
| 38 | Kaiser Permanente-Woodland Hills | Woodland Hills | California | United States | 91367 |
| 39 | Rocky Mountain Cancer Centers-Aurora | Aurora | Colorado | United States | 80012 |
| 40 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 41 | Rocky Mountain Cancer Centers-Boulder | Boulder | Colorado | United States | 80304 |
| 42 | National Jewish Health-Main Campus | Denver | Colorado | United States | 80206 |
| 43 | Rocky Mountain Cancer Centers-Midtown | Denver | Colorado | United States | 80218 |
| 44 | SCL Health Saint Joseph Hospital | Denver | Colorado | United States | 80218 |
| 45 | Rocky Mountain Cancer Centers-Rose | Denver | Colorado | United States | 80220 |
| 46 | Mountain Blue Cancer Care Center - Swedish | Englewood | Colorado | United States | 80113 |
| 47 | Swedish Medical Center | Englewood | Colorado | United States | 80113 |
| 48 | National Jewish Health-Western Hematology Oncology | Golden | Colorado | United States | 80401 |
| 49 | North Colorado Medical Center | Greeley | Colorado | United States | 80631 |
| 50 | Good Samaritan Medical Center | Lafayette | Colorado | United States | 80026 |
| 51 | Rocky Mountain Cancer Centers-Sky Ridge | Lone Tree | Colorado | United States | 80124 |
| 52 | McKee Medical Center | Loveland | Colorado | United States | 80539 |
| 53 | National Jewish Health-Northern Hematology Oncology | Thornton | Colorado | United States | 80260 |
| 54 | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
| 55 | Yale University | New Haven | Connecticut | United States | 06520 |
| 56 | Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | United States | 06611 |
| 57 | Veterans Affairs Connecticut Healthcare System-West Haven Campus | West Haven | Connecticut | United States | 06516 |
| 58 | Bayhealth Hospital Kent Campus | Dover | Delaware | United States | 19901 |
| 59 | Bayhealth Hospital Sussex Campus | Milford | Delaware | United States | 19963 |
| 60 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 61 | Cleveland Clinic-Weston | Weston | Florida | United States | 33331 |
| 62 | University Cancer and Blood Center LLC | Athens | Georgia | United States | 30607 |
| 63 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
| 64 | Northeast Georgia Medical Center Braselton | Braselton | Georgia | United States | 30517 |
| 65 | Northside Hospital - Duluth | Duluth | Georgia | United States | 30096 |
| 66 | Northside Hospital - Gwinnett | Lawrenceville | Georgia | United States | 30046 |
| 67 | Lewis Cancer and Research Pavilion at Saint Joseph's/Candler | Savannah | Georgia | United States | 31405 |
| 68 | Suburban Hematology Oncology Associates - Snellville | Snellville | Georgia | United States | 30078 |
| 69 | Hawaii Cancer Care - Savio | 'Aiea | Hawaii | United States | 96701 |
| 70 | Hawaii Cancer Care Inc-POB II | Honolulu | Hawaii | United States | 96813 |
| 71 | Queen's Cancer Cenrer - POB I | Honolulu | Hawaii | United States | 96813 |
| 72 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 73 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813 |
| 74 | Queen's Cancer Center - Kuakini | Honolulu | Hawaii | United States | 96817 |
| 75 | Saint Luke's Mountain States Tumor Institute | Boise | Idaho | United States | 83712 |
| 76 | Kootenai Medical Center | Coeur d'Alene | Idaho | United States | 83814 |
| 77 | Saint Luke's Mountain States Tumor Institute - Fruitland | Fruitland | Idaho | United States | 83619 |
| 78 | Saint Luke's Mountain States Tumor Institute - Meridian | Meridian | Idaho | United States | 83642 |
| 79 | Saint Luke's Mountain States Tumor Institute - Nampa | Nampa | Idaho | United States | 83686 |
| 80 | Kootenai Cancer Center | Post Falls | Idaho | United States | 83854 |
| 81 | Kootenai Cancer Clinic | Sandpoint | Idaho | United States | 83864 |
| 82 | Saint Luke's Mountain States Tumor Institute-Twin Falls | Twin Falls | Idaho | United States | 83301 |
| 83 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
| 84 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 85 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 86 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 87 | University of Chicago Comprehensive Cancer Center | Chicago | Illinois | United States | 60637 |
| 88 | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | United States | 62526 |
| 89 | Illinois CancerCare-Dixon | Dixon | Illinois | United States | 61021 |
| 90 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 91 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
| 92 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
| 93 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 94 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 95 | UC Comprehensive Cancer Center at Silver Cross | New Lenox | Illinois | United States | 60451 |
| 96 | University of Chicago Medicine-Orland Park | Orland Park | Illinois | United States | 60462 |
| 97 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 98 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
| 99 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 100 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
| 101 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
| 102 | Genesis Cancer Center - Silvis | Silvis | Illinois | United States | 61282 |
| 103 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 104 | Springfield Clinic | Springfield | Illinois | United States | 62702 |
| 105 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 106 | Parkview Regional Medical Center | Fort Wayne | Indiana | United States | 46845 |
| 107 | Goshen Center for Cancer Care | Goshen | Indiana | United States | 46526 |
| 108 | Franciscan Health Indianapolis | Indianapolis | Indiana | United States | 46237 |
| 109 | Franciscan Health Mooresville | Mooresville | Indiana | United States | 46158 |
| 110 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 111 | Mary Greeley Medical Center | Ames | Iowa | United States | 50010 |
| 112 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 113 | McFarland Clinic PC-Boone | Boone | Iowa | United States | 50036 |
| 114 | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | United States | 50325 |
| 115 | Mercy Cancer Center-West Lakes | Clive | Iowa | United States | 50325 |
| 116 | Greater Regional Medical Center | Creston | Iowa | United States | 50801 |
| 117 | Genesis Medical Center - East Campus | Davenport | Iowa | United States | 52803 |
| 118 | Genesis Cancer Care Institute | Davenport | Iowa | United States | 52804 |
| 119 | Iowa Cancer Specialists | Davenport | Iowa | United States | 52807 |
| 120 | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | United States | 50314 |
| 121 | Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 122 | McFarland Clinic PC-Trinity Cancer Center | Fort Dodge | Iowa | United States | 50501 |
| 123 | McFarland Clinic PC-Jefferson | Jefferson | Iowa | United States | 50129 |
| 124 | McFarland Clinic PC-Marshalltown | Marshalltown | Iowa | United States | 50158 |
| 125 | Mercy Medical Center-West Lakes | West Des Moines | Iowa | United States | 50266 |
| 126 | HaysMed University of Kansas Health System | Hays | Kansas | United States | 67601 |
| 127 | University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | United States | 66210 |
| 128 | Salina Regional Health Center | Salina | Kansas | United States | 67401 |
| 129 | University of Kansas Health System Saint Francis Campus | Topeka | Kansas | United States | 66606 |
| 130 | University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | United States | 66205 |
| 131 | Saint Joseph Hospital East | Lexington | Kentucky | United States | 40509 |
| 132 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 133 | Medical Center of Baton Rouge | Baton Rouge | Louisiana | United States | 70816 |
| 134 | Ochsner High Grove | Baton Rouge | Louisiana | United States | 70836 |
| 135 | Ochsner Medical Center Kenner | Kenner | Louisiana | United States | 70065 |
| 136 | Ochsner Medical Center Jefferson | New Orleans | Louisiana | United States | 70121 |
| 137 | Western Maryland Regional Medical Center | Cumberland | Maryland | United States | 21502 |
| 138 | Lahey Hospital and Medical Center | Burlington | Massachusetts | United States | 01805 |
| 139 | UMass Memorial Medical Center - University Campus | Worcester | Massachusetts | United States | 01655 |
| 140 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 141 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
| 142 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 143 | IHA Hematology Oncology Consultants-Canton | Canton | Michigan | United States | 48188 |
| 144 | Saint Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 145 | IHA Hematology Oncology Consultants-Chelsea | Chelsea | Michigan | United States | 48118 |
| 146 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 147 | Henry Ford Macomb Hospital-Clinton Township | Clinton Township | Michigan | United States | 48038 |
| 148 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 149 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 150 | Great Lakes Cancer Management Specialists-Doctors Park | East China Township | Michigan | United States | 48054 |
| 151 | Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | United States | 48503 |
| 152 | Genesee Hematology Oncology PC | Flint | Michigan | United States | 48503 |
| 153 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 154 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 155 | Academic Hematology Oncology Specialists | Grosse Pointe Woods | Michigan | United States | 48236 |
| 156 | Great Lakes Cancer Management Specialists-Van Elslander Cancer Center | Grosse Pointe Woods | Michigan | United States | 48236 |
| 157 | Michigan Breast Specialists-Grosse Pointe Woods | Grosse Pointe Woods | Michigan | United States | 48236 |
| 158 | Allegiance Health | Jackson | Michigan | United States | 49201 |
| 159 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 160 | Sparrow Hospital | Lansing | Michigan | United States | 48912 |
| 161 | Hope Cancer Clinic | Livonia | Michigan | United States | 48154 |
| 162 | Saint Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
| 163 | Great Lakes Cancer Management Specialists-Macomb Medical Campus | Macomb | Michigan | United States | 48044 |
| 164 | Mercy Health Mercy Campus | Muskegon | Michigan | United States | 49444 |
| 165 | Cancer and Hematology Centers of Western Michigan - Norton Shores | Norton Shores | Michigan | United States | 49444 |
| 166 | Spectrum Health Reed City Hospital | Reed City | Michigan | United States | 49677 |
| 167 | Great Lakes Cancer Management Specialists-Rochester Hills | Rochester Hills | Michigan | United States | 48309 |
| 168 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
| 169 | Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan | United States | 48604 |
| 170 | Marie Yeager Cancer Center | Saint Joseph | Michigan | United States | 49085 |
| 171 | Ascension Saint Joseph Hospital | Tawas City | Michigan | United States | 48764 |
| 172 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 173 | Great Lakes Cancer Management Specialists-Macomb Professional Building | Warren | Michigan | United States | 48093 |
| 174 | Saint John Macomb-Oakland Hospital | Warren | Michigan | United States | 48093 |
| 175 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 176 | IHA Hematology Oncology Consultants-Ann Arbor | Ypsilanti | Michigan | United States | 48197 |
| 177 | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | United States | 56601 |
| 178 | Essentia Health - Deer River Clinic | Deer River | Minnesota | United States | 56636 |
| 179 | Essentia Health Cancer Center | Duluth | Minnesota | United States | 55805 |
| 180 | Essentia Health Hibbing Clinic | Hibbing | Minnesota | United States | 55746 |
| 181 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 182 | Minneapolis VA Medical Center | Minneapolis | Minnesota | United States | 55417 |
| 183 | Essentia Health Sandstone | Sandstone | Minnesota | United States | 55072 |
| 184 | Essentia Health Virginia Clinic | Virginia | Minnesota | United States | 55792 |
| 185 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 186 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 187 | Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | United States | 63141 |
| 188 | Parkland Health Center - Farmington | Farmington | Missouri | United States | 63640 |
| 189 | Truman Medical Centers | Kansas City | Missouri | United States | 64108 |
| 190 | University of Kansas Cancer Center - North | Kansas City | Missouri | United States | 64154 |
| 191 | University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | United States | 64064 |
| 192 | University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | United States | 64116 |
| 193 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 194 | Mercy Hospital South | Saint Louis | Missouri | United States | 63128 |
| 195 | Siteman Cancer Center-South County | Saint Louis | Missouri | United States | 63129 |
| 196 | Missouri Baptist Medical Center | Saint Louis | Missouri | United States | 63131 |
| 197 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 198 | Siteman Cancer Center at Saint Peters Hospital | Saint Peters | Missouri | United States | 63376 |
| 199 | Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | United States | 63670 |
| 200 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
| 201 | Missouri Baptist Sullivan Hospital | Sullivan | Missouri | United States | 63080 |
| 202 | Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | United States | 63127 |
| 203 | Bozeman Deaconess Hospital | Bozeman | Montana | United States | 59715 |
| 204 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 205 | OptumCare Cancer Care at Oakey | Las Vegas | Nevada | United States | 89102 |
| 206 | OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | United States | 89148 |
| 207 | New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | United States | 03301 |
| 208 | Solinsky Center for Cancer Care | Manchester | New Hampshire | United States | 03103 |
| 209 | Monmouth Medical Center | Long Branch | New Jersey | United States | 07740 |
| 210 | Virtua Samson Cancer Center | Moorestown | New Jersey | United States | 08057 |
| 211 | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | United States | 08876 |
| 212 | Virtua Voorhees | Voorhees | New Jersey | United States | 08043 |
| 213 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87102 |
| 214 | Presbyterian Kaseman Hospital | Albuquerque | New Mexico | United States | 87110 |
| 215 | Memorial Medical Center - Las Cruces | Las Cruces | New Mexico | United States | 88011 |
| 216 | Presbyterian Rust Medical Center/Jorgensen Cancer Center | Rio Rancho | New Mexico | United States | 87124 |
| 217 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 218 | Mary Imogene Bassett Hospital | Cooperstown | New York | United States | 13326 |
| 219 | Arnot Ogden Medical Center/Falck Cancer Center | Elmira | New York | United States | 14905 |
| 220 | University of Rochester | Rochester | New York | United States | 14642 |
| 221 | Durham VA Medical Center | Durham | North Carolina | United States | 27705 |
| 222 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 223 | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina | United States | 28791 |
| 224 | Sanford Bismarck Medical Center | Bismarck | North Dakota | United States | 58501 |
| 225 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 226 | Sanford Roger Maris Cancer Center | Fargo | North Dakota | United States | 58122 |
| 227 | UHHS-Chagrin Highlands Medical Center | Beachwood | Ohio | United States | 44122 |
| 228 | Strecker Cancer Center-Belpre | Belpre | Ohio | United States | 45714 |
| 229 | Geauga Hospital | Chardon | Ohio | United States | 44024 |
| 230 | Adena Regional Medical Center | Chillicothe | Ohio | United States | 45601 |
| 231 | Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
| 232 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 233 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 234 | Columbus Oncology and Hematology Associates Inc | Columbus | Ohio | United States | 43214 |
| 235 | Grant Medical Center | Columbus | Ohio | United States | 43215 |
| 236 | The Mark H Zangmeister Center | Columbus | Ohio | United States | 43219 |
| 237 | Doctors Hospital | Columbus | Ohio | United States | 43228 |
| 238 | Delaware Health Center-Grady Cancer Center | Delaware | Ohio | United States | 43015 |
| 239 | Mercy Cancer Center-Elyria | Elyria | Ohio | United States | 44035 |
| 240 | Cleveland Clinic Cancer Center Mansfield | Mansfield | Ohio | United States | 44906 |
| 241 | Marietta Memorial Hospital | Marietta | Ohio | United States | 45750 |
| 242 | OhioHealth Marion General Hospital | Marion | Ohio | United States | 43302 |
| 243 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
| 244 | UH Seidman Cancer Center at Landerbrook Health Center | Mayfield Heights | Ohio | United States | 44124 |
| 245 | UH Seidman Cancer Center at Lake Health Mentor Campus | Mentor | Ohio | United States | 44060 |
| 246 | UH Seidman Cancer Center at Southwest General Hospital | Middleburg Heights | Ohio | United States | 44130 |
| 247 | Licking Memorial Hospital | Newark | Ohio | United States | 43055 |
| 248 | University Hospitals Parma Medical Center | Parma | Ohio | United States | 44129 |
| 249 | Southern Ohio Medical Center | Portsmouth | Ohio | United States | 45662 |
| 250 | University Hospitals Portage Medical Center | Ravenna | Ohio | United States | 44266 |
| 251 | North Coast Cancer Care | Sandusky | Ohio | United States | 44870 |
| 252 | UH Seidman Cancer Center at Firelands Regional Medical Center | Sandusky | Ohio | United States | 44870 |
| 253 | Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | United States | 44136 |
| 254 | ProMedica Flower Hospital | Sylvania | Ohio | United States | 43560 |
| 255 | University Hospitals Sharon Health Center | Wadsworth | Ohio | United States | 44281 |
| 256 | South Pointe Hospital | Warrensville Heights | Ohio | United States | 44122 |
| 257 | UH Seidman Cancer Center at Saint John Medical Center | Westlake | Ohio | United States | 44145 |
| 258 | UHHS-Westlake Medical Center | Westlake | Ohio | United States | 44145 |
| 259 | Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | United States | 44691 |
| 260 | Genesis Healthcare System Cancer Care Center | Zanesville | Ohio | United States | 43701 |
| 261 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 262 | Mercy Hospital Oklahoma City | Oklahoma City | Oklahoma | United States | 73120 |
| 263 | Kaiser Permanente Northwest | Portland | Oregon | United States | 97227 |
| 264 | Salem Hospital | Salem | Oregon | United States | 97301 |
| 265 | Ephrata Cancer Center | Ephrata | Pennsylvania | United States | 17522 |
| 266 | Adams Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
| 267 | Cherry Tree Cancer Center | Hanover | Pennsylvania | United States | 17331 |
| 268 | UPMC Pinnacle Cancer Center/Community Osteopathic Campus | Harrisburg | Pennsylvania | United States | 17109 |
| 269 | Sechler Family Cancer Center | Lebanon | Pennsylvania | United States | 17042 |
| 270 | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 271 | Fox Chase Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 272 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 273 | University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | United States | 15232 |
| 274 | Pottstown Hospital | Pottstown | Pennsylvania | United States | 19464 |
| 275 | UPMC Susquehanna | Williamsport | Pennsylvania | United States | 17701 |
| 276 | WellSpan Health-York Cancer Center | York | Pennsylvania | United States | 17403 |
| 277 | AnMed Health Cancer Center | Anderson | South Carolina | United States | 29621 |
| 278 | Prisma Health Cancer Institute - Easley | Easley | South Carolina | United States | 29640 |
| 279 | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | United States | 29605 |
| 280 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
| 281 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 282 | Prisma Health Cancer Institute - Greer | Greer | South Carolina | United States | 29650 |
| 283 | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | United States | 29672 |
| 284 | Prisma Health Cancer Institute - Spartanburg | Spartanburg | South Carolina | United States | 29307 |
| 285 | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | United States | 57104 |
| 286 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 287 | The Don and Sybil Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 288 | Centra Lynchburg Hematology-Oncology Clinic Inc | Lynchburg | Virginia | United States | 24501 |
| 289 | Virginia Cancer Institute | Richmond | Virginia | United States | 23230 |
| 290 | VCU Massey Cancer Center at Stony Point | Richmond | Virginia | United States | 23235 |
| 291 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
| 292 | VCU Community Memorial Health Center | South Hill | Virginia | United States | 23970 |
| 293 | Shenandoah Oncology PC | Winchester | Virginia | United States | 22601 |
| 294 | Jefferson Healthcare | Port Townsend | Washington | United States | 98368 |
| 295 | Edwards Comprehensive Cancer Center | Huntington | West Virginia | United States | 25701 |
| 296 | Langlade Hospital and Cancer Center | Antigo | Wisconsin | United States | 54409 |
| 297 | Duluth Clinic Ashland | Ashland | Wisconsin | United States | 54806 |
| 298 | Aurora Cancer Care-Southern Lakes VLCC | Burlington | Wisconsin | United States | 53105 |
| 299 | Aurora Health Care Germantown Health Center | Germantown | Wisconsin | United States | 53022 |
| 300 | Aurora Cancer Care-Grafton | Grafton | Wisconsin | United States | 53024 |
| 301 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 302 | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | United States | 54303 |
| 303 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 304 | Aurora Cancer Care-Kenosha South | Kenosha | Wisconsin | United States | 53142 |
| 305 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 306 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 307 | Aurora Bay Area Medical Group-Marinette | Marinette | Wisconsin | United States | 54143 |
| 308 | Aspirus Medford Hospital | Medford | Wisconsin | United States | 54451 |
| 309 | Froedtert Menomonee Falls Hospital | Menomonee Falls | Wisconsin | United States | 53051 |
| 310 | Aurora Cancer Care-Milwaukee | Milwaukee | Wisconsin | United States | 53209 |
| 311 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 312 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 313 | Aurora Sinai Medical Center | Milwaukee | Wisconsin | United States | 53233 |
| 314 | Saint Vincent Hospital Cancer Center at Oconto Falls | Oconto Falls | Wisconsin | United States | 54154 |
| 315 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 316 | Aurora Cancer Care-Racine | Racine | Wisconsin | United States | 53406 |
| 317 | Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan | Wisconsin | United States | 53081 |
| 318 | Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | United States | 54235-1495 |
| 319 | Aurora Medical Center in Summit | Summit | Wisconsin | United States | 53066 |
| 320 | Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers | Wisconsin | United States | 54241 |
| 321 | Aspirus Regional Cancer Center | Wausau | Wisconsin | United States | 54401 |
| 322 | Aurora Cancer Care-Milwaukee West | Wauwatosa | Wisconsin | United States | 53226 |
| 323 | Aurora West Allis Medical Center | West Allis | Wisconsin | United States | 53227 |
| 324 | Froedtert West Bend Hospital/Kraemer Cancer Center | West Bend | Wisconsin | United States | 53095 |
| 325 | Aspirus UW Cancer Center | Wisconsin Rapids | Wisconsin | United States | 54494 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ferdinandos Skoulidis, Southwest Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S1900C
- NCI-2019-07142
- S1900C
- S1900C
- U10CA180888