Lung-MAP: A Master Screening Protocol for Previously-Treated Non-Small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/28/2019
Start Date:January 28, 2019
End Date:April 1, 2022
Contact:Mariah Norman
Email:mnorman@swog.org
Phone:210-614-8808

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LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening 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 (Lung-MAP). 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
non-match sub-studies which will include all screened patients not eligible for any of the
biomarker-driven sub-studies.

Primary Objective of the Master Protocol (LUNGMAP)

The primary objective of this screening study is to test patient specimens to determine
eligibility for participation in the biomarker-driven and non-matched sub-studies included
within the Lung-MAP umbrella protocol.

Secondary Objectives

1. Screening Success Rate Objective

To evaluate the screen success rate defined as the percentage of screened patients that
register for a therapeutic sub-study. Screen success rates will be evaluated for the
total screened population and by the subset of patients screened following progression
on previous therapy or pre-screened on current therapy.

2. Translational Medicine Objectives

1. To evaluate circulating tumor DNA (ctDNA) and compare to the FMI Foundation tissue
molecular profiling results in patients who submit a new biopsy for screening.

2. To establish a tissue/blood repository.

Ancillary Study S1400GEN Objectives

The Lung-MAP Screening Study includes an ancillary study evaluating patient and physician
attitudes regarding the return of somatic mutation findings suggestive of a germline
mutation. Participation in this study is optional.

1. Primary Objective

To evaluate patient attitudes and preferences about return of somatic mutation findings
suggestive of a germline mutation in the Lung-MAP Screening Study.

2. Secondary Objectives

1. To evaluate Lung-MAP study physician attitudes and preferences about return of
somatic mutation findings suggestive of a germline mutation in the Lung-MAP
Screening Study.

2. To evaluate Lung-MAP patients' and study physicians' knowledge of cancer genomics.

3. To evaluate Lung-MAP patients' and study physicians' knowledge of the design of the
Lung-MAP Screening Study.

4. To explore whether physician and patient knowledge of cancer genomics and attitudes
and preferences about return of genomic profiling findings are correlated.

5.1 Registration

Step 0:

1. Patients who need the fresh biopsy must also submit whole blood for ctDNA testing (see
Section 15.3). These patients must be registered to Step 0 to obtain a patient ID
number for the submission.

Patients registered to Step 0 are not registered to the LUNGMAP protocol. To
participate in LUNGMAP, patients must be registered to Step 1 after evaluation of
patient eligibility, including tumor tissue adequacy, per protocol Section 5.1, Step
1.

Patients registered at Step 0 must use the same SWOG patient ID for registration at
Step 1.

Step 1:

2. Patients must have pathologically proven non-small cell lung cancer (all histologic
types) confirmed by tumor biopsy and/or fine-needle aspiration. Disease must be Stage
IV as defined in Section 4.0, or recurrent. The primary diagnosis of non-small cell
lung cancer should be established using the current WHO/IASLC-classification of
Thoracic Malignancies. All histologies, including mixed, are allowed.

3. Patients must either be eligible to be screened at progression on prior treatment or
to be pre-screened prior to progression on current treatment.

These criteria are:

1. Screening at progression on prior treatment:

To be eligible for screening at progression, patients must have received at least
one line of systemic therapy for any stage of disease (Stages I-IV) and must have
progressed during or following their most recent line of therapy.

- For patients whose prior systemic therapy was for Stage I-III disease only
(i.e. patient has not received any treatment for Stage IV or recurrent
disease), disease progression on platinum-based chemotherapy must have
occurred within one year from the last date that patient received that
therapy. For patients treated with consolidation anti-PD-1 or anti-PD-L1
therapy for Stage III disease, disease progression on consolidation
anti-PD-1 or anti-PD-L1 therapy must have occurred within one year from the
date or initiation of such therapy.

- For patients whose prior therapy was for Stage IV or recurrent disease, the
patient must have received at least one line of a platinum-based
chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination
(e.g. Nivolumab or Pembrolizumab).

2. Pre-Screening prior to progression on current treatment:

To be eligible for pre-screening, current treatment must be for Stage IV or recurrent
disease and patient must have received at least one dose of the current regimen.
Patients must have previously received or currently be receiving a platinum-based
chemotherapy regimen or anti-PD-1/PD-L1 therapy, alone or in combination (e.g.
Nivolumab or Pembrolizumab). Patients on first-line treatment are eligible upon
receiving Cycle 1, Day 1 infusion. Note: Patients will not receive their sub-study
assignment until they progress and the LUNGMAP Notice of Progression is submitted.

4. Patients must have adequate tumor tissue available, defined as ≥ 20% tumor cells and ≥
0.2 mm3 tumor volume.

- The local interpreting pathologist must review the specimen.

- The pathologist must sign the LUNGMAP Local Pathology Review Form confirming
tissue adequacy prior to Step 1 registration.

Patients must agree to have this tissue submitted to Foundation Medicine for common
broad platform CLIA biomarker profiling, PD-L1, and c-MET IHC (see Section 15.2). If
archival tumor material is exhausted, then a new fresh tumor biopsy that is
formalin-fixed and paraffin-embedded (FFPE) must be obtained. Patients who need the
fresh biopsy must also submit whole peripheral blood for ctDNA testing. A tumor block
or FFPE slides 4-5 microns thick must be submitted. Bone biopsies are not allowed. If
FFPE slides are to be submitted, at least 12 unstained slides plus an H&E stained
slide, or 13 unstained slides must be submitted. However, it is strongly recommended
that 20 FFPE slides be submitted. Note: Previous next-generation DNA sequencing (NGS)
will be repeated if done outside this study for sub-study assignment.

Patients must agree to have any tissue that remains after testing retained for the use
of sub-study Translational Medicine (TM) studies at the time of consent the patient is
enrolled in.

5. Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion,
ROS 1 gene rearrangement, or BRAF V600E mutation are not eligible unless they have
progressed following all standard of care targeted therapy. EGFR/ALK/ROS/BRAF testing
is not required prior to Step 1 registration, as it is included in the Foundation One
testing for screening/pre-screening.

6. Patients must have Zubrod performance status 0-1 (see Section 10.2) documented within
28 days prior to Step 1 registration.

7. Patients must be ≥ 18 years of age.

8. Patients must also be offered participation in banking for future use of specimens as
described in Section 15.0.

9. Patients must be willing to provide prior smoking history as required on the LUNGMAP
Onstudy Form.

10. As a part of the OPEN registration process (see Section 13.4 for OPEN access
instructions) 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.

11. 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.

12. U.S. patients who can complete the survey and the interview by telephone or email in
English must be offered participation in the S1400GEN Survey Ancillary Study if local
institution's policies allow participants to receive the Amazon gift card (see
Sections 15.7 and 18.5). Patients at institutions that cannot offer the survey must
still participate in the main study.
We found this trial at
305
sites
800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Principal Investigator: Peter Rubin
Phone: 207-626-4855
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Hibba Tul Rehman
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
Principal Investigator: Ryan D. Gentzler
Phone: 434-243-6303
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: John C. Ruckdeschel
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Khaled A. Tolba
Phone: 503-494-1080
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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808 North 39th Avenue
Yakima, Washington 98902
Principal Investigator: John A. Keech
Phone: 509-574-3535
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-487-7447
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-486-6000
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2226 Liliha Street
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Principal Investigator: Jeffrey L. Berenberg
Phone: 808-678-9000
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Amarillo, Texas 79106
Principal Investigator: Anita Ravipati
Phone: 806-212-1985
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Ames, Iowa 50010
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Antioch, California 94531
Principal Investigator: Jennifer M. Suga
Phone: 877-642-4691
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364 White Oak St
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(336) 625-5151
Principal Investigator: Vinay K. Gudena
Phone: 336-832-0836
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Principal Investigator: David K. Goebel
Phone: 888-823-5923
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1625 Maple Lane
Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Sreekanth C. Reddy
Phone: 404-303-3355
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Auburn, Washington 98001
Principal Investigator: John A. Keech
Phone: 253-887-9333
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6701 N Charles St
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(443) 849-2000
Principal Investigator: Mei Tang
Phone: 443-849-3706
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Baton Rouge, Louisiana 70816
Principal Investigator: Marc R. Matrana
Phone: 225-761-5346
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Baton Rouge, Louisiana 70836
Principal Investigator: Marc R. Matrana
Phone: 504-703-8712
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Bellevue, Washington 98004
Principal Investigator: John A. Keech
Phone: 425-688-5407
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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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Biddeford, Maine 04005
Principal Investigator: Peter Rubin
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
Phone: 701-323-5760
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Bonne Terre, Missouri 63628
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Boone, Iowa 50036
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
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Braselton, Georgia 30517
Principal Investigator: Charles H. Nash
Phone: 770-219-8800
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Brewer, Maine 04412
Principal Investigator: Thomas H. Openshaw
Phone: 800-987-3005
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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7575 Grand River Avenue
Brighton, Michigan 48114
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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Burlington, Massachusetts 01805
Principal Investigator: Brendan Connell
Phone: 781-744-8027
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Burlington, North Carolina 27216
Principal Investigator: Vinay K. Gudena
Phone: 336-538-7725
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Burlington, Vermont 05405
Principal Investigator: Hibba Tul Rehman
Phone: 802-656-4101
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3123 Medical Dr
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
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1600 South Canton Center Road
Canton, Michigan 48188
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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1600 South Canton Center Road
Canton, Michigan 48188
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: Bryan A. Faller
Phone: 573-334-2230
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: Bryan A. Faller
Phone: 573-651-5550
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Centralia, Illinois 62801
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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14650 East Old US Highway 12
Chelsea, Michigan 48118
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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775 South Main Street
Chelsea, Michigan 48118
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
Principal Investigator: Adedayo A. Onitilo
Phone: 800-782-8581
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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Cody, Wyoming 82414
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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Coeur d'Alene, Idaho 83814
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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1500 West Poplar Avenue
Collierville, Tennessee 38017
Principal Investigator: Raymond U. Osarogiagbon
Phone: 901-226-1366
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, Colorado 80907
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Columbus, Ohio 43213
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
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Columbus, Ohio 43222
Principal Investigator: Timothy D. Moore
Phone: 614-234-5433
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: Timothy D. Moore
Phone: 614-566-4475
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
Principal Investigator: Timothy D. Moore
Phone: 614-488-2118
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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Concord, New Hampshire 03301
Principal Investigator: Douglas J. Weckstein
Phone: 603-224-2556
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Corbin, Kentucky 40701
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Cumberland, Maryland 21502
Principal Investigator: Blanche H. Mavromatis
Phone: 240-964-1400
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210 West McKinley Avenue
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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115 10th Avenue Northeast
Deer River, Minnesota 56636
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Detroit, Michigan 48236
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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1027 Washington Avenue
Detroit Lakes, Minnesota 56501
Principal Investigator: Bret E. Friday
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 888-203-7267
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Durango, Colorado 81301
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Easley, South Carolina 29640
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Easton, Maryland 21601
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2200 Craig Road
Eau Claire, Wisconsin 54701
Principal Investigator: Adedayo A. Onitilo
Phone: 800-782-8581
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Effingham, Illinois 62401
Principal Investigator: Yujie Zhao
Phone: 800-446-5532
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Effingham, IL
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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913 North Dixie Highway
Elizabethtown, Kentucky 42701
Principal Investigator: Donald E. Goodin
Phone: 270-234-3250
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Elizabethtown, KY
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Elmira, New York 14905
Principal Investigator: Serge Dauphin
Phone: 607-271-7000
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Elmira, NY
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1202 East Locust Street
Emmett, Idaho 83617
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Emmett, ID
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Ephrata, Pennsylvania 17522
Principal Investigator: Chanh T. Huynh
Phone: 717-721-4840
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Ephrata, PA
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Ephrata, Pennsylvania 17522
Principal Investigator: Chanh T. Huynh
Phone: 888-823-5923
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Principal Investigator: Bryan A. Faller
Phone: 309-243-3605
Illinois CancerCare - Eureka Illinois CancerCare is one of the largest private oncology and hematology...
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Eureka, IL
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Fairbanks, Alaska 99701
Principal Investigator: John A. Keech
Phone: 907-458-3043
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Fairbanks, AK
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Fargo, North Dakota 58103
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Fargo, ND
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Fergus Falls, Minnesota 56537
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Fergus Falls, MN
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Flint, Michigan 48503
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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Flint, MI
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302 Kensington Avenue
Flint, Michigan 48503
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
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Flint, MI
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Principal Investigator: Philip J. Stella
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Flint, MI
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Fort Dodge, Iowa 50501
Principal Investigator: Joseph J. Merchant
Phone: 515-956-4132
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Fort Dodge, IA
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