Last updated on September 2018

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer


Brief description of study

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Detailed Study Description

PRIMARY OBJECTIVES:

Screening component:

I. To establish a National Clinical Trials Network (NCTN) mechanism for genomically screening large but homogeneous cancer populations and subsequently assigning and accruing simultaneously to a multi-sub-study ?Master Protocol.? II. To evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study.

Sub-study-specific Objectives:

Design #1: Phase II/III Design:

III. To evaluate if there is sufficient evidence to continue to the Phase III component of the sub-study by comparing investigator-assessed progression-free survival (IA-PFS) between investigational therapy versus standard therapy (SoC) in patients with advanced stage refractory squamous cell carcinoma (SCCA) of the lung. (Phase II) IV. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS among advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC. (Phase III) V. To compare overall survival (OS) in patients with advanced stage refractory SCCA of the lung randomized to investigational therapy versus SoC. (Phase III)

Design #2: Phase II followed by Phase III (Sequential Phase II to Phase III):

VI. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial). (Phase II) VII. To determine if there is both a statistically and clinically-meaningful difference in IA-PFS among advanced stage refractory SCCA of the lung randomized to receive investigational therapy versus SoC. (Phase III) VIII. To compare overall survival (OS) in patients with advanced stage refractory SCCA of the lung randomized to investigational therapy versus SoC. (Phase III)

SECONDARY OBJECTIVES:

Sub-study-specific Objectives:

Design #1: Phase II/III Design:

I. To compare response rates (confirmed and unconfirmed, complete and partial responses) among patients randomized to receive investigational therapy versus SoC. (Phase II) II. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase II) III. To evaluate the duration of response (DoR) among patients who achieve a complete response (CR) or a partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) (1.1). (Phase II) III. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus SoC. (Phase III) IV. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase III)

Design #2: Phase II followed by Phase III (Sequential Phase II to Phase III):

V. To evaluate PFS and OS with investigational therapy. (Phase II) VI. To evaluate the DoR among patients who achieve a CR or PR (confirmed and unconfirmed) by RECIST 1.1. (Phase II) VII. To evaluate the frequency and severity of toxicities associated with investigational therapy. (Phase II) VIII. To compare the response rates (confirmed and unconfirmed, complete and partial) among patients randomized to receive investigational therapy versus SoC. (Phase III) IX. To evaluate the frequency and severity of toxicities associated with investigational therapy versus SoC. (Phase III)

TERTIARY OBJECTIVES:

I. To evaluate the treatment arm randomization acceptance rate (TARAR) within each treatment arm of each sub-study defined as the percentage of patients randomized to a treatment arm that receive any protocol treatment. (Design #1: Phase II/III Design) II. To identify additional predictive tumor/blood biomarkers that may modify response or define resistance to the targeted therapy (TT)/targeted therapy combination (TTC) beyond the chosen biomarker for biomarker-driven sub-studies.

III. To evaluate potentially predictive biomarkers for non-match therapy (NMT) in the non-match studies.

IV. To identify potential resistance biomarkers at disease progression. V. To establish a tissue/ blood repository from patients with refractory SCCA of the lung.

OUTLINE: Patients are assigned to a biomarker-driven targeted therapy phase II study. If the objectives response rate observed is judged sufficient, patients proceed to a randomized phase III trial and are randomized to biomarker-driven targeted therapy or standard of care.

S1400A: (CLOSED TO ACCRUAL 12/18/2015) Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study are assigned to Arm I. Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period (Arm III).

ARM I: (CLOSED TO ACCRUAL 12/18/2015) Patients receive anti-B7H1 monoclonal antibody MEDI4736 intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 4/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15)

ARM III: For patients assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, patients may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Patients will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Patients receive anti-B7H1 monoclonal antibody MEDI4736 intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity.

S1400B (CLOSED TO ACCRUAL 12/12/2016): Patients with tumors positive for phosphoinositide 3-kinase (PI3KCA) are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, GCD-0032 after disease progression on current treatment (Arm III).

ARM I: Patients receive taselisib orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)

ARM III: Re-Registration Treatment with GDC-0032 (Taselisib) Upon progression patients in Arm 2 may be eligible for Re-Registration to receive GDC-0032. Patients receive taselisib orally (PO) daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

S1400C (CLOSED TO ACCRUAL 09/01/2016): Patients with tumors positive for cyclin dependent kinase 4 (CDK4), cyclin D1 (CCND1), cyclin D2 (CCND2), and cyclin D3 (CCND3) are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, palbociclib, after disease progression on current treatment (Arm III).

ARM I: Patients receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)

ARM III: Re-Registration Treatment with Palbociclib. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive palbociclib. Patients receive palbociclib PO on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

S1400D (CLOSED TO ACCRUAL 10/31/2016): Patients with tumors positive for fibroblast growth factor receptor (FGFR) 1, FGFR2, and FGFR3 are assigned to Arm I. Patients currently on Arm 2, docetaxel will be given the option to re-register to Arm 3, AZD4547, after disease progression on current treatment (Arm III).

ARM I: Patients receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 12/18/2015): Patients receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #3 12/18/2015)

ARM III: Re-Registration Treatment with AZD4547. Upon progression patients in Arm 2 may be eligible for Re-Registration to receive AZD4547. Patients receive FGFR inhibitor AZD4547 PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

S1400E (CLOSED TO ACCRUAL 11/25/2014): Patients with tumors positive for met proto-oncogene (MET) are randomized to 1 of 2 treatment arms. (permanently closed to accrual on 11/25/14)

ARM I: Patients receive rilotumumab IV on day 1 and erlotinib hydrochloride PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive erlotinib hydrochloride PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

S1400F: Patients with disease progression during or after prior anti-PD-1 or anti-PD-L1 antibody monotherapy as their most recent line of treatment receive durvalumab (IV over 60 minutes) and tremelimumab (IV over 60 minutes) on day 1 for courses 1-4 and durvalumab IV alone on day 1 of course 5 and subsequent courses until disease progression or unacceptable toxicity. Courses repeat every 28 days.

S1400G: Patients with tumors positive for homologous recombination repair deficiency receive talazoparib PO daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

S1400I: Patients with tumors that do not match one of the currently active drug-biomarker combinations or did not meet the eligibility requirements for that bio-marker driven sub-study are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, all patients are followed up periodically for up to 3 years from date of screening registration.

Clinical Study Identifier: NCT02154490

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Cone Health Cancer Center

Greensboro, NC United States
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High Point Regional Hospital

High Point, NC United States
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Duke Raleigh Hospital

Raleigh, NC United States
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Annie Penn Memorial Hospital

Reidsville, NC United States
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Mercy Medical Center

Canton, OH United States
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Aultman Health Foundation

Canton, OH United States
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Bethesda North Hospital

Cincinnati, OH United States
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Riverside Methodist Hospital

Columbus, OH United States
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Grant Medical Center

Columbus, OH United States
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Doctors Hospital

Columbus, OH United States
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Grady Memorial Hospital

Delaware, OH United States
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Kettering Medical Center

Kettering, OH United States
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Fairfield Medical Center

Lancaster, OH United States
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Marietta Memorial Hospital

Marietta, OH United States
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Hillcrest Hospital Cancer Center

Mayfield Heights, OH United States
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Knox Community Hospital

Mount Vernon, OH United States
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Licking Memorial Hospital

Newark, OH United States
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Southern Ohio Medical Center

Portsmouth, OH United States
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North Coast Cancer Care

Sandusky, OH United States
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Flower Hospital

Sylvania, OH United States
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University of Toledo

Toledo, OH United States
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South Pointe Hospital

Warrensville Heights, OH United States
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Saint Ann's Hospital

Westerville, OH United States
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UHHS-Westlake Medical Center

Westlake, OH United States
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Bay Area Hospital

Coos Bay, OR United States
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Kaiser Permanente Northwest

Portland, OR United States
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Salem Hospital

Salem, OR United States
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Geisinger Medical Center

Danville, PA United States
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Ephrata Cancer Center

Ephrata, PA United States
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Ephrata Community Hospital

Ephrata, PA United States
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Adams Cancer Center

Gettysburg, PA United States
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Cherry Tree Cancer Center

Hanover, PA United States
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Jefferson Hospital

Jefferson Hills, PA United States
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Lewistown Hospital

Lewistown, PA United States
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Riddle Memorial Hospital

Media, PA United States
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Forbes Hospital

Monroeville, PA United States
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Allegheny Valley Hospital

Natrona Heights, PA United States
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Paoli Memorial Hospital

Paoli, PA United States
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Fox Chase Cancer Center

Philadelphia, PA United States
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Temple University Hospital

Philadelphia, PA United States
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Allegheny General Hospital

Pittsburgh, PA United States
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West Penn Hospital

Pittsburgh, PA United States
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Community Medical Center

Scranton, PA United States
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Geisinger Medical Group

State College, PA United States
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Chester County Hospital

West Chester, PA United States
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Reading Hospital

West Reading, PA United States
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UPMC Susquehanna

Williamsport, PA United States
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Lankenau Medical Center

Wynnewood, PA United States
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Rhode Island Hospital

Providence, RI United States
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Miriam Hospital

Providence, RI United States
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AnMed Health Cancer Center

Anderson, SC United States
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Roper Hospital

Charleston, SC United States
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Gibbs Cancer Center-Gaffney

Gaffney, SC United States
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Saint Francis Hospital

Greenville, SC United States
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Lexington Medical Center

West Columbia, SC United States
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Avera Cancer Institute

Sioux Falls, SD United States
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Brooke Army Medical Center

Fort Sam Houston, TX United States
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Ben Taub General Hospital

Houston, TX United States
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M D Anderson Cancer Center

Houston, TX United States
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University Medical Center

Lubbock, TX United States
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Sandra L Maxwell Cancer Center

Cedar City, UT United States
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Logan Regional Hospital

Logan, UT United States
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LDS Hospital

Salt Lake City, UT United States
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Harrison Medical Center

Bremerton, WA United States
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Skagit Valley Hospital

Mount Vernon, WA United States
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Jefferson Healthcare

Port Townsend, WA United States
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Peninsula Cancer Center

Poulsbo, WA United States
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Legacy Salmon Creek Hospital

Vancouver, WA United States
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United Hospital Center

Bridgeport, WV United States
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Saint Mary's Medical Center

Huntington, WV United States
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Aurora Health Center-Fond du Lac

Fond Du Lac, WI United States
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Aurora Cancer Care-Grafton

Grafton, WI United States
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Aurora BayCare Medical Center

Green Bay, WI United States
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Mercy Health System

Janesville, WI United States
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UW Cancer Center Johnson Creek

Johnson Creek, WI United States
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Holy Family Memorial Hospital

Manitowoc, WI United States
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Marshfield Clinic

Marshfield, WI United States
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Marshfield Medical Center

Marshfield, WI United States
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Community Memorial Hospital

Menomonee Falls, WI United States
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Aurora Cancer Care-Milwaukee

Milwaukee, WI United States
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Aurora Sinai Medical Center

Milwaukee, WI United States
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ProHealth D N Greenwald Center

Mukwonago, WI United States
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Cancer Center of Western Wisconsin

New Richmond, WI United States
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Green Bay Oncology - Oconto Falls

Oconto Falls, WI United States
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Aurora Cancer Care-Racine

Racine, WI United States
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Saint Mary's Hospital

Rhinelander, WI United States
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Saint Michael's Hospital

Stevens Point, WI United States
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Green Bay Oncology - Sturgeon Bay

Sturgeon Bay, WI United States
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Aurora Cancer Care-Waukesha

Waukesha, WI United States
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Saint Clare's Hospital

Weston, WI United States
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Aspirus UW Cancer Center

Wisconsin Rapids, WI United States
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Rocky Mountain Oncology

Casper, WY United States
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Billings Clinic-Cody

Cody, WY United States
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Welch Cancer Center

Sheridan, WY United States
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Kaiser Permanente-Fontana

Fontana, CA United States
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Kaiser Permanente-Fresno

Fresno, CA United States
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City of Hope Mission Hills

Mission Hills, CA United States
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Kaiser Permanente-Woodland Hills

Woodland Hills, CA United States
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UCHealth Memorial Hospital Central

Colorado Springs, CO United States
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Saint Joseph Mercy Canton

Canton, MI United States
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Henry Ford West Bloomfield Hospital

West Bloomfield, MI United States
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Valley Hospital

Ridgewood, NJ United States
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Mount Sinai Union Square

New York, NY United States
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Indu and Raj Soin Medical Center

Beavercreek, OH United States
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Pottstown Hospital

Pottstown, PA United States
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Shenandoah Oncology PC

Winchester, VA United States
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Ascension Saint Mary's Hospital

Rhinelander, WI United States
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Ascension Saint Michael's Hospital

Stevens Point, WI United States
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Kaiser San Rafael-Gallinas

San Rafael, CA United States
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Parkview Hospital Randallia

Fort Wayne, IN United States
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Trinity Regional Medical Center

Fort Dodge, IA United States
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Mercy Health Mercy Campus

Muskegon, MI United States
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Lakeland Hospital Niles

Niles, MI United States
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Capital Region Southwest Campus

Jefferson City, MO United States
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Armes Family Cancer Center

Findlay, OH United States
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Blanchard Valley Hospital

Findlay, OH United States
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Orion Cancer Care

Findlay, OH United States
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Mercy Hospital Oklahoma City

Oklahoma City, OK United States
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Camden Clark Medical Center

Parkersburg, WV United States
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HSHS Sacred Heart Hospital

Eau Claire, WI United States
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HSHS Saint Nicholas Hospital

Sheboygan, WI United States
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