Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)
Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)
This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.
PRIMARY OBJECTIVE:
I. To compare the disease free survival (DFS) between Arm B versus (vs) Arm C in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. To compare the overall survival (OS) between the two treatment arms in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
II. To compare the adverse event rates and drug discontinuation rates due to adverse events in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
III. To compare the adverse event (AE) rates for Arms B and C with A (prior to Update #7) and estimate the DFS and OS in Arm A.
IV. To compare the DFS and OS in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer that receive at least 2 cycles of initial adjuvant chemotherapy.
QUALITY OF LIFE OBJECTIVES:
I. To compare patient-reported quality of life (QOL) one year after randomization as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core (C)30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B), and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C).
II. To compare patient-reported QOL at completion of chemotherapy as assessed by the EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy followed by pembrolizumab (Arm B) and those randomized to receive adjuvant chemotherapy + pembrolizumab concomitantly (Arm C).
III. To present longitudinal trajectories by arm of patient-reported dyspnea and coughing as assessed by the EORTC QLQ-Lung Cancer (LC13).
CORRELATIVE SCIENCE OBJECTIVES:
I. To compare the DFS and OS in the PD-L1 subgroup of patients with PD-L1 expression status (>= 1% vs < 1%).
II. To compare the DFS and OS by tumor mutational burden status (high vs. low) in patients with stage IIA-IIIB (T3-4N2) non-small cell lung cancer.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A (CLOSED AS OF UPDATE #7 on 2/1/2022):
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then undergo observation.
ARM B:
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then receive pembrolizumab intravenously (IV) over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 17 cycles or every 6 weeks for 16 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.
ARM C:
INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10/14/2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
CONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10/14/2020) in the absence of disease progression or unacceptable toxicity.
Patients also undergo echocardiogram (ECHO) as clinically indicated during screening and on the trial. Patients may undergo magnetic resonance imaging (MRI) during screening and as clinically indicated on the trial, as well as computed tomography (CT) and blood sample collection throughout the trial.
*ACCEPTABLE REGIMENS: DOUBLET I: Patients receive cisplatin IV and pemetrexed IV over 10 minutes on day 1 of each cycle.
DOUBLET II: Patients receive carboplatin IV over and pemetrexed IV over 10 minutes on day 1 of each cycle.
DOUBLET III: Patients receive cisplatin IV on day 1 of each cycle and gemcitabine hydrochloride IV on days 1 and 8 of each cycle.
DOUBLET IV: Patients receive carboplatin IV and paclitaxel IV over 1-96 hours on day 1 of each cycle.
After completion of study treatment, patients are followed up at 6 weeks, then every 3 months for 2 years from randomization, every 6 months for years 2-4 from randomization, and then annually for up to 10 years from randomization.
Inclusion Criteria:
A female of childbearing potential is a sexually mature female who:
Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)
Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)
Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263
Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017
Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery
No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis
No prior allogeneic tissue/solid organ transplant
Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements
No current pneumonitis or history of (non-infectious) pneumonitis that required steroids
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1
No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible
No hypersensitivity (>= grade 3) to pembrolizumab and/or any of its excipients
No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
No known hepatitis C virus (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin >= 8 gm/dl
Calculated (Calc.) creatinine clearance >= 45 mL/min
Total bilirubin =< 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
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MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
CTOResearch@hfhs.org313-916-3721
248-551-7695
CTOResearch@hfhs.org313-916-3721
Kkeenan1@hfhs.org313-343-3166
248-551-7695
wstrong@ghci.org810-762-8038
wstrong@ghci.org810-762-8038
wstrong@ghci.org810-762-8038
crcwm-regulatory@crcwm.org616-391-1230
kforman1@hfhs.org313-343-3166
karen.forman@ascension.org313-343-3166
kforman1@hfhs.org313-343-3166
CTOResearch@hfhs.org313-916-3721
crcwm-regulatory@crcwm.org616-391-1230
crcwm-regulatory@crcwm.org616-391-1230
574-647-7370
harsha.trivedi@umhsparrow.org517-364-3712
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
616-391-1230
CTOResearch@hfhs.org313-916-3721
Emily.Crofts@trinity-health.org248-858-6215
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
crcwm-regulatory@crcwm.org616-391-1230
248-551-7695
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
crcwm-regulatory@crcwm.org616-391-1230
kfife3@hfhs.org248-849-5332
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
crcwm-regulatory@crcwm.org616-391-1230
248-551-7695
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
kforman1@hfhs.org313-343-3166
CTOResearch@hfhs.org313-916-3721
crcwm-regulatory@crcwm.org616-391-1230
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
MCRCwebsitecontactform@stjoeshealth.org734-712-7251
OncologyClinicalTrialsFargo@sanfordhealth.org218-333-5000
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
218-786-3308
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
612-467-2800
mmcorc@healthpartners.com952-993-1517
coborncancercenter@centracare.com877-229-4907
mmcorc@healthpartners.com952-993-1517
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
CancerTrials@EssentiaHealth.org218-786-3308
mmcorc@healthpartners.com952-993-1517
BCCclintrials@bmhcc.org901-226-1366
BCCclintrials@bmhcc.org901-226-1366
601-815-6700
BCCclintrials@bmhcc.org901-226-1366
BCCclintrials@bmhcc.org901-226-1366
BCCclintrials@bmhcc.org901-226-1366
888-446-3729
sfmc@sfmc.net573-334-2230
314-205-6936
info@siteman.wustl.edu800-600-3606
573-882-7440
info@siteman.wustl.edu800-600-3606
314-996-5569
LJCrockett@freemanhealth.com417-347-4030
816-404-4375
aroland@kccop.org913-948-5588
aroland@kccop.org913-948-5588
clinicaltrials@lakeregional.com573-302-2768
Trisha.England2@mymlc.com816-271-7937
314-996-5569
info@siteman.wustl.edu800-600-3606
protocols@AllianceNCTN.org773-702-9171
Danielle.Werle@mercy.net314-525-6042
info@siteman.wustl.edu800-600-3606
314-996-5569
info@siteman.wustl.edu800-600-3606
314-251-7066
314-996-5569
mccinfo@mtcancer.org406-969-6060
research@billingsclinic.org800-996-2663
mccinfo@mtcancer.org406-969-6060
mccinfo@mtcancer.org406-969-6060
mccinfo@mtcancer.org406-969-6060
mccinfo@mtcancer.org406-969-6060
unmcrsa@unmc.edu402-559-6941
unmcrsa@unmc.edu402-559-6941
ResearchInstituteInquiries@CommonSpirit.org720-874-1881
research@cancerpartners.com402-327-7363
402-334-4773
402-354-5144
402-559-5600
unmcrsa@unmc.edu402-559-6941
research@sncrf.org702-384-0013
research@sncrf.org702-384-0013
603-224-2556
cancer.research.nurse@dartmouth.edu800-639-6918
800-339-6484
clinicaltrialsresearch@valleyhealth.com201-634-5792
clinicaltrialsresearch@valleyhealth.com201-634-5792
HSC-ClinicalTrialInfo@salud.unm.edu505-925-0348
WBurman@phs.org505-559-6113
516-734-8896
718-765-2500
askroswell@roswellpark.org800-767-9355
315-472-7504
Stephanie.Solito@chsli.org516-325-7514
315-472-7504
518-926-6700
516-734-8896
McDowelE@upstate.edu315-464-8230
tia.derosa@rochestergeneral.org585-922-3536
585-275-5830
914-366-1600
800-862-2215
315-464-5476
315-464-5476
eskwak@montefiore.org718-379-6866
eskwak@montefiore.org718-379-6866
kl2965@cumc.columbia.edu718-584-9000
McDowelE@upstate.edu315-464-8230
516-326-7514
mcortese@wphospital.org914-849-7582
stacey.phelps@conehealth.com336-832-0836
stacey.phelps@conehealth.com336-832-0836
888-716-9259
888-275-3853
tammy.cozad@caromonthealth.org704-834-2810
stacey.phelps@conehealth.com336-832-0836
stacey.phelps@conehealth.com336-832-0836
jcwilliams@firsthealth.org910-715-3500
stacey.phelps@conehealth.com336-832-0836
704-872-3630
336-713-6771
OncologyClinicalTrialsFargo@sanfordhealth.org701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org701-234-6161
CancerAnswer@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
ClinicalReserachDept@aultman.com330-363-7274
clinical.trials@daytonncorp.org937-528-2900
Jeffh@columbusccop.org877-779-7585
ababal@metrohealth.org216-778-7559
TaussigResearch@ccf.org866-223-8100
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
clinical.trials@daytonncorp.org937-528-2900
937-569-7515
TaussigResearch@ccf.org866-223-8100
clinical.trials@daytonncorp.org937-528-2900
Jeffh@columbusccop.org614-488-2745
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
Jeffh@columbusccop.org614-488-2745
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
888-874-7000
PCIOncResearch@promedica.org419-824-1842
Jeffh@columbusccop.org614-488-2745
clinical.trials@daytonncorp.org937-528-2900
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
TaussigResearch@ccf.org866-223-8100
Jeffh@columbusccop.org614-488-2745
877-231-4440
ou-clinical-trials@ouhsc.edu405-271-8777
405-752-3402
405-773-6613
stmock@samhealth.org541-768-4352
541-472-7000
research@asante.org541-789-4673
CanRsrchStudies@providence.org503-215-2614
mccinfo@mtcancer.org406-969-6060
CanRsrchStudies@providence.org503-215-2614
CanRsrchStudies@providence.org503-215-2614
information@kpchr.org503-335-2400
Morgan_M.Horton@lvhn.org610-402-9543
protocols@AllianceNCTN.org773-702-9171
haneydl@upmc.edu412-389-5208
Morgan_M.Horton@lvhn.org610-402-9543
turzoe@mlhs.org484-476-2649
protocols@AllianceNCTN.org773-702-9171
717-217-6020
cancerresearch@geisinger.edu570-271-5251
cancerresearch@geisinger.edu877-204-6081
ctsucontact@westat.com888-823-5923
Morgan_M.Horton@lvhn.org610-402-9543
717-721-4840
ClinicalResearchServices@upmc.edu412-864-7716
protocols@AllianceNCTN.org773-702-9171
877-441-7957
724-838-1900
717-632-1559
klitchfield@PINNACLEHEALTH.org717-724-6765
cancerresearch@geisinger.edu570-459-2901
haneydl@upmc.edu412-389-5208
814-534-4724
doxenberg@wellspan.org717-741-8303
cancerresearch@geisinger.edu570-523-9200
412-647-8073
haneydl@upmc.edu412-389-5208
turzoe@mlhs.org484-476-2649
ClinicalResearchServices@upmc.edu412-864-7716
haneydl@upmc.edu412-389-5208
haneydl@upmc.edu412-389-5208
724-230-3030
haneydl@upmc.edu412-389-5208
turzoe@mlhs.org484-476-2649
ONCTrialNow@jefferson.edu215-600-9151
215-728-4790
215-728-2983
412-784-4900
800-533-8762
412-647-8073
412-367-6454
412-502-3920
cancerresearch@geisinger.edu800-275-6401
800-836-0388
cancerresearch@geisinger.edu570-703-4768
814-676-7900
protocols@AllianceNCTN.org773-702-9171
protocols@AllianceNCTN.org773-702-9171
412-653-8100
610-988-9323
HemonCCTrials@geisinger.edu570-271-5251
800-598-4282
protocols@AllianceNCTN.org773-702-9171
turzoe@mlhs.org484-476-2649
877-441-7957
877-441-7957
717-724-6760
401-444-1488
fdallesandro@chartercare.org401-456-2698
underberga@sjchs.org912-819-5704
Kim.Williams3@prismahealth.org864-522-4317
Julia.Johnson@rsfh.com843-724-2466
hcc-clinical-trials@musc.edu843-792-9321
Kim.Williams3@prismahealth.org864-522-4317
kmertz-rivera@gibbscc.org864-560-6104
Heather_Rich@bshsi.org864-603-6234
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
Heather_Rich@bshsi.org864-603-6234
Kim.Williams3@prismahealth.org864-522-4317
Kim.Williams3@prismahealth.org864-522-4317
kmertz-rivera@gibbscc.org864-560-6104
underberga@sjchs.org912-819-5704
Kim.Williams3@prismahealth.org864-522-4317
kmertz-rivera@gibbscc.org864-560-6104
kmertz-rivera@gibbscc.org864-560-6104
research@lexhealth.org803-935-8300
OncologyClinicTrialsSF@sanfordhealth.org605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org605-312-3320
BCCclintrials@bmhcc.org901-226-1366
charles.mays@balladhealth.org423-431-5654
charles.mays@balladhealth.org423-431-5654
BCCclintrials@bmhcc.org901-226-1366
325-670-6340
protocols@AllianceNCTN.org773-702-9171
canceranswerline@UTSouthwestern.edu214-590-5582
canceranswerline@utsouthwestern.edu214-648-7097
canceranswerline@UTSouthwestern.edu214-648-7097
713-790-2700
832-522-2873
281-242-2873
hmthewoodlands@houstonmethodist.org713-790-2700
cancer.research.nurse@hitchcock.org800-639-6918
charles.mays@balladhealth.org423-431-5654
540-332-5960
Kevin.Patel@centrahealth.com434-200-1495
Charmaine.A.Mckie@kp.org240-632-4285
charles.mays@balladhealth.org423-431-5654
smoore@vacancer.com804-287-3000
ctoclinops@vcu.edu
CTOclinops@vcu.edu804-628-6430
nemer.elmouallem@vcuhealth.org
Charmaine.A.Mckie@kp.org240-632-4285
research@kadlecmed.org509-783-4637
research@valleymed.org425-228-3440
cancertrialsinfo@hsc.wvu.edu304-293-7374
Christina.Cole@chhi.org304-399-6566
cancertrialsinfo@hsc.wvu.edu304-293-7374
cancertrialsinfo@hsc.wvu.edu304-293-7374
304-243-6442
Juli.Alford@aspirus.org715-623-9869
ResearchDept@thedacare.org920-364-3604
AWRI.inquiry@ascension.org
CancerTrials@EssentiaHealth.org218-786-3308
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
AWRI.inquiry@ascension.org
oncology.clinical.trials@marshfieldresearch.org800-782-8581
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
920-435-8326
WI_research_admin@hshs.org920-433-8889
wi_research_admin@hshs.org920-433-8889
ncorp@aurora.org414-302-2304
clinicaltrials@cancer.wisc.edu800-622-8922
ncorp@aurora.org414-302-2304
cancerctr@gundersenhealth.org608-775-2385
608-256-1901 ext. 17007
clinicaltrials@cancer.wisc.edu800-622-8922
clinicaltrials@cancer.wisc.edu800-622-8922
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
Beth.Knetter@aspirus.org715-847-2353
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
414-805-3666
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
research.institute@phci.org
ResearchDept@thedacare.org920-364-3605
mmcorc@healthpartners.com952-993-1517
262-928-7878
WI_research_admin@hshs.org920-433-8889
AWRI.inquiry@ascension.org
ncorp@aurora.org414-302-2304
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
Beth.Knetter@aspirus.org715-847-2353
oncology.clinical.trials@marshfieldresearch.org800-782-8581
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
wi_research_admin@hshs.org920-433-8889
ncorp@aurora.org414-302-2304
262-928-7632
Chanda.miller@phci.org262-928-5539
877-405-6866
AWRI.Inquiry@Ascension.org
ncorp@aurora.org414-302-2304
ncorp@aurora.org414-302-2304
oncology.clinical.trials@marshfieldresearch.org800-782-8581
715-422-7718