Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial
NCT ID: NCT06498635
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
306 participants
INTERVENTIONAL
2025-04-01
2039-07-15
Brief Summary
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Detailed Description
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I. To compare disease free survival (DFS) in stage II-IIIB non-small cell lung cancer participants who achieved a pathologic complete response (pCR) following standard of care neoadjuvant chemo-immunotherapy and are randomized to adjuvant durvalumab (MEDI4736) versus surveillance.
SECONDARY OBJECTIVES:
I. To compare the overall survival (OS) between the arms. II. To evaluate the frequency and severity of toxicities of adjuvant durvalumab (MEDI4736).
III. To compare the event free survival (EFS) between the arms.
TRANSLATIONAL MEDICINE OBJECTIVE:
I. To bank specimens and images for additional future translational medicine studies.
QUALITY OF LIFE (QOL) PRIMARY OBJECTIVE:
I. To compare patient-reported quality of life (QOL) status between treatment arms at 6 months from randomization using the Functional Assessment of Cancer Therapy-Lung (FACT-L) Trial Outcome Index (TOI).
QOL SECONDARY OBJECTIVES:
I. To compare patient-reported QOL between treatment arms at 24 weeks (6 months) from randomization using the Functional Assessment of Cancer Therapy-Biologic Response Modifier (FACT-BRM) physical and mental subscale scores.
II. To compare longitudinal changes in global health status between treatment arms from randomization to 48 week (12 months) using the FACT-L TOI.
PATIENT REPORTED OUTCOMES-COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (PRO-CTCAE) OBJECTIVE:
I. To compare participant-reported symptoms using selected PRO-CTCAE items between treatment arms such as rash, itching, skin dryness, numbness, and tingling.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) and blood sample collection throughout the trial.
ARM II: Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial.
After completion of study treatment, patients are followed up annually until 10 years from randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (durvalumab)
Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT and blood sample collection throughout the trial.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Durvalumab
Given IV
Questionnaire Administration
Ancillary studies
Arm II (active surveillance)
Patients undergo active surveillance for 12 months on study. Patients undergo CT and blood sample collection throughout the trial.
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Patient Observation
Undergo active surveillance
Questionnaire Administration
Ancillary studies
Interventions
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Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT
Durvalumab
Given IV
Patient Observation
Undergo active surveillance
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network \[NCCN\] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.
* Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease
* Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review
* Participants must have a PD-L1 status result (e.g. \[\< 1% versus \>= 1% or unknown\])
* Participants must not have known EGFR mutations, or ALK gene fusion
* Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines
* Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study
* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization
* Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy
* Participants must not have received post-operative radiation therapy (PORT) for NSCLC
* Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator
* Participant must be ≥ 18 years old at time of study entry
* Participants must have body weight \> 30 kg
* Participant must have Zubrod performance status of 0-2
* Participant must have a complete medical history and physical exam within 28 days prior to randomization
* Hemoglobin \> 9.0 g/dL (within 28 days prior to randomization)
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to randomization)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to randomization)
* Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)
* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)
* Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx
* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization
* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated
* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated
* Participants must not have had an organ transplant
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy
* Participants must not have received a live or live attenuated vaccine within 28 days prior randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed
* Participants must be offered the opportunity to participate in specimen banking
* Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree to participate in the patient-reported outcome study
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Jeremy P Cetnar
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Midstate Medical Center
Meriden, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, United States
Northwestern Medicine Huntley Hospital
Huntley, Illinois, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic - Ames
Ames, Iowa, United States
McFarland Clinic - Boone
Boone, Iowa, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, United States
HaysMed
Hays, Kansas, United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
UPMC Western Maryland
Cumberland, Maryland, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Lahey Medical Center-Peabody
Peabody, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Corewell Health Reed City Hospital
Reed City, Michigan, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
University of Michigan Health - West
Wyoming, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Fairview Southdale Hospital
Edina, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi, United States
Baptist Cancer Center-Grenada
Grenada, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
University Health Truman Medical Center
Kansas City, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Logan Health Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
James J Peters VA Medical Center
The Bronx, New York, United States
Duke Cancer Center Cary
Cary, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Duke Cancer Center Raleigh
Raleigh, North Carolina, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Hood River Memorial Hospital
Hood River, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, United States
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States
Riddle Memorial Hospital
Media, Pennsylvania, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Reading Hospital
West Reading, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, United States
Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Duluth Clinic Ashland
Ashland, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Aspirus Medford Hospital
Medford, Wisconsin, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, United States
Sheboygan Physicians Group
Sheboygan, Wisconsin, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, United States
Countries
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Facility Contacts
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Other Identifiers
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NCI-2024-05588
Identifier Type: REGISTRY
Identifier Source: secondary_id
S2414
Identifier Type: OTHER
Identifier Source: secondary_id
S2414
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2024-05588
Identifier Type: -
Identifier Source: org_study_id