Recruiting
Phase 2

Biomarker Selected Treatments

Sponsor:

SWOG Cancer Research Network

Code:

NCT06769126

Conditions

Extensive Stage Lung Small Cell Carcinoma

Lung Small Cell Carcinoma, A Subtype

Lung Small Cell Carcinoma, I Subtype

Lung Small Cell Carcinoma, N Subtype

Lung Small Cell Carcinoma, P Subtype

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Ceralasertib

Computed Tomography

Durvalumab

Etoposide

Study Details

Brief summary:

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Conditions

Extensive Stage Lung Small Cell Carcinoma

Lung Small Cell Carcinoma, A Subtype

Lung Small Cell Carcinoma, I Subtype

Lung Small Cell Carcinoma, N Subtype

Lung Small Cell Carcinoma, P Subtype

Study ID

NCT06769126

Start date

Nov 6, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: 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
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a history of limited stage small cell lung cancer
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must meet 1 of the following criteria prior to step 1:

  • Treatment naïve and planning to receive frontline induction treatment with platinum plus etoposide in combination with durvalumab, OR,
  • Have initiated frontline induction therapy and completed at least 1 (≥ 1) cycle and at most 3 (≤ 3) cycles of platinum and etoposide. At most 2 (≤ 2) of these cycles could have been given without durvalumab

  • NOTE: Participants must not have received immunotherapy other than durvalumab (e.g., atezolizumab) prior to enrollment
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any anti PD-1 or anti PD-L1 (including durvalumab \[MEDI4736\]) treatment for SCLC prior to starting frontline induction treatment for ES-SCLC
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received anti PD-1 or anti PD-L1 other than durvalumab (MEDI4736) as part of frontline induction treatment for ES-SCLC. Participants must have not received atezolizumab, pembrolizumab, or nivolumab as part of frontline induction treatment
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for SCLC treatment while receiving treatment on this study

  • NOTE: If participant has bone metastases, bisphosphonates are allowed
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be ≥ 18 years old at the time of step 1 registration
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be able to safely receive the frontline induction treatment with platinum plus etoposide in combination with durvalumab, per the current Food and Drug Administration (FDA)-approved package insert(s), institutional guidelines, and the treating investigator's discretion
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 1 registration
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator within 28 days prior to step 1 registration
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have had an allogenic organ transplantation
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants 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
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: 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
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have adequate tumor tissue available from SCLC and agree to have these tissue specimens submitted. Participants must agree to have any leftover tissue (tissue that remains after subtype and biomarker testing) retained for the use of future correlative studies.

  • NOTE: After a participant has been registered to step 1 registration, the tissue must be submitted to BostonGene. Sites will receive a notification from the Southwest Oncology Group (SWOG) Statistics and Data Management Center within 19 days after tissue submission. Patients must not be registered to step 2 prior to receiving notification of cohort assignment
  • NOTE: A histologic review will be performed to confirm adequate cellularity for the testing. If inadequate cellularity, additional archival unstained slides from the same participant may be submitted if it does not exceed the window of starting maintenance therapy
  • STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: 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
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) of the participant's SLFN11 testing results and have been determined to have subtype A, N, I, or P: confirmed by BostonGene and assigned to a cohort
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants may have measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and must have their disease assessed by CT of chest/abdomen/pelvis (with contrast unless contraindicated) within 28 days prior to step 2 for measurable disease or within 42 days prior to step 2 for non-measurable disease. All known sites of disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1). Any lesions assessed using a non-diagnostic PET/CT of chest/abdomen/pelvis will be considered non-measurable lesions
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to step 2 randomization. Participant must not have leptomeningeal disease, spinal cord compression, or symptomatic brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to step 2 randomization
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with untreated brain metastases must be asymptomatic and stable off steroids prior to step 2 randomization.

  • NOTE: Exceptions to corticosteroid criterion are: (1) intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), (2) systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent, or (3) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). Premedication with steroids for chemotherapy is acceptable
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced disease progression in the opinion of treating investigator during induction treatment and prior to step 2
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have completed frontline induction therapy. Induction therapy must have included 4-6 cycles of platinum plus etoposide and 4 cycles of durvalumab (MEDI4736); at most 2 (≤ 2) cycles of platinum plus etoposide may have been given without durvalumab (MEDI4736). Durvalumab (MEDI4736) must have been given in combination with platinum plus etoposide
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants who received consolidation thoracic radiation therapy must have completed all radiation therapy at least 14 days prior to step 2
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants not receiving consolidation thoracic radiation, step 2 registration must occur at least 3 weeks but not more than 6 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \[MEDI4736\])
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants receiving consolidation thoracic radiation after induction therapy, step 2 registration must occur at least 3 weeks but no more than 8 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \[MEDI4736\])
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received atezolizumab, pembrolizumab, or nivolumab as part of their frontline induction treatment. Participants must not have received prophylactic cranial irradiation (PCI)
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a complete medical history and physical within 28 days prior to step 2
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have body weight > 30 kg
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 2
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Hemoglobin > 9.0 g/dL (within 28 days prior to step 2)
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to step 2)
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Platelets ≥ 100 x 10\^3/uL (within 28 days prior to step 2)
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Total bilirubin ≤ 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 step 2)
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Aspartate aminotransferase (AST)/alanine transaminase (ALT) ≤ 5 × institutional ULN (within 28 days prior to step 2)
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have creatinine ≤ 1.5x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance ≥ 45 mL/min using the following Cockcroft-Gault Formula For creatinine clearance formula see the tools on the Cancer Research and Biostatistics (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: 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 step 2 registration
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE 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
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured or currently be receiving treatment for HVC. 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
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced the following during induction treatment: Any grade 3 or worse immune-mediated adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved grade 2 irAE, nor have experienced a toxicity that led to permanent discontinuation of prior durvalumab (MEDI4736). Toxicity of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: 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
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received a live or live attenuated vaccine within 30 days prior to step 2. 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 COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed
  • STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A, Arm 1 (durvalumab)

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 positive or patients with subtype P ES-SCLC.

INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated.

MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

experimental: Cohort A, Arm 2 (durvalumab, saruparib)

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 positive or patients with subtype P ES-SCLC.

INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated.

MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle and saruparib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

experimental: Cohort B, Arm 1 (durvalumab)

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 negative.

INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated.

MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

experimental: Cohort B, Arm 2 (durvalumab, ceralasertib)

Patients with ES-SCLC determined to be subtype A or N, and to be SLFN11 negative.

INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated.

MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 8 and ceralasertib PO BID on days 1-7 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

experimental: Cohort C, Arm 1 (durvalumab)

Patients with ES-SCLC determined to be subtype I.

INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated.

MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

experimental: Cohort C, Arm 2 (durvalumab, monalizumab)

Patients with ES-SCLC determined to be subtype I.

INDUCTION: Patients may receive a platinum compound plus etoposide per standard care as well as durvalumab IV over 60 minutes on day 1 of each cycle. Cycles repeat every 28 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients may undergo thoracic radiation as clinically indicated.

MAINTENANCE: Patients receive durvalumab IV over 60 minutes on day 1 and monalizumab IV over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or PET/CT scan and CT scan or MRI throughout the study. Patients also undergo tissue sample collection during screening and may undergo blood sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo tissue and blood sample collection

Ceralasertib

Given PO

Computed Tomography

Undergo CT scan

Durvalumab

Given IV

Etoposide

Given etoposide

Magnetic Resonance Imaging

Undergo MRI

Monalizumab

Given IV

Platinum Compound

Given platinum compound

Positron Emission Tomography

Undergo PET/CT scan

Saruparib

Given PO

Thoracic Radiation Therapy

Undergo thoracic radiation

Primary outcome measure

  • Screen success rate (Screening) [ Time Frame: Up to 3 years ]
  • Progression-free survival (PFS) (Cohort A) [ Time Frame: From date of randomization to treatment within a cohort to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years ]
  • PFS (Cohort B) [ Time Frame: From date of randomization to treatment within a cohort to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years ]
  • PFS (Cohort C) [ Time Frame: From date of randomization to treatment within a cohort to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years ]

Central Contacts and Locations

Locations

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Site Public Contact

909-558-4050

Principal Investigator:

Hamid R. Mirshahidi

Eisenhower Medical Center

Recruiting

Rancho Mirage, California, United States, 92270

Contacts

Site Public Contact

760-834-3798

Principal Investigator:

Davood Vafai

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Surbhi Singhal

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Kyle Concannon

UCHealth Memorial Hospital Central

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

Site Public Contact

719-365-2406

Principal Investigator:

Kyle Concannon

Memorial Hospital North

Recruiting

Colorado Springs, Colorado, United States, 80920

Contacts

Site Public Contact

719-364-6700

Principal Investigator:

Kyle Concannon

Poudre Valley Hospital

Recruiting

Fort Collins, Colorado, United States, 80524

Contacts

Site Public Contact

970-297-6150

Principal Investigator:

Kyle Concannon

Cancer Care and Hematology-Fort Collins

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Kyle Concannon

Lutheran Hospital - Cancer Centers of Colorado

Recruiting

Golden, Colorado, United States, 80401

Contacts

Site Public Contact

peaksresearch@imail.org

Principal Investigator:

Karng S. Log

UCHealth Greeley Hospital

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Kyle Concannon

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Site Public Contact

970-203-7083

Principal Investigator:

Kyle Concannon

Smilow Cancer Hospital-Derby Care Center

Recruiting

Derby, Connecticut, United States, 06418

Contacts

Principal Investigator:

Anne C. Chiang

Smilow Cancer Hospital Care Center-Fairfield

Recruiting

Fairfield, Connecticut, United States, 06824

Contacts

Principal Investigator:

Anne C. Chiang

Smilow Cancer Hospital Care Center - Guilford

Recruiting

Guilford, Connecticut, United States, 06437

Contacts

Principal Investigator:

Anne C. Chiang

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Anne C. Chiang

Yale-New Haven Hospital North Haven Medical Center

Recruiting

North Haven, Connecticut, United States, 06473

Contacts

Principal Investigator:

Anne C. Chiang

Smilow Cancer Hospital-Torrington Care Center

Recruiting

Torrington, Connecticut, United States, 06790

Contacts

Principal Investigator:

Anne C. Chiang

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, United States, 06611

Contacts

Principal Investigator:

Anne C. Chiang

Smilow Cancer Hospital-Waterbury Care Center

Recruiting

Waterbury, Connecticut, United States, 06708

Contacts

Principal Investigator:

Anne C. Chiang

Smilow Cancer Hospital Care Center - Waterford

Recruiting

Waterford, Connecticut, United States, 06385

Contacts

Principal Investigator:

Anne C. Chiang

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Principal Investigator:

Gregory A. Masters

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Principal Investigator:

Mark A. Taylor

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Principal Investigator:

John M. Schallenkamp

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Principal Investigator:

Elie G. Dib

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Principal Investigator:

John M. Schallenkamp

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Young Kwang Chae

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Site Public Contact

708-226-4357

Principal Investigator:

Nan Sethakorn

Northwestern Medicine Oak Brook

Recruiting

Oak Brook, Illinois, United States, 60523

Contacts

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Young Kwang Chae

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Young Kwang Chae

Mary Greeley Medical Center

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Principal Investigator:

Joseph J. Merchant

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Mercy Hospital

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-365-4673

Principal Investigator:

Deborah W. Wilbur

Oncology Associates at Mercy Medical Center

Recruiting

Cedar Rapids, Iowa, United States, 52403

Contacts

Site Public Contact

319-363-2690

Principal Investigator:

Deborah W. Wilbur

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

McFarland Clinic - Trinity Cancer Center

Recruiting

Fort Dodge, Iowa, United States, 50501

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Marshalltown

Recruiting

Marshalltown, Iowa, United States, 50158

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

The Iowa Clinic PC

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-875-9815

Principal Investigator:

Seema Harichand-Herdt

University of Kansas Clinical Research Center

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Principal Investigator:

Anusha Chidharla

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Anusha Chidharla

The University of Kansas Cancer Center - Olathe

Recruiting

Olathe, Kansas, United States, 66061

Contacts

Principal Investigator:

Anusha Chidharla

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Principal Investigator:

Anusha Chidharla

Salina Regional Health Center

Recruiting

Salina, Kansas, United States, 67401

Contacts

Principal Investigator:

Anusha Chidharla

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Principal Investigator:

Anusha Chidharla

Baptist Health Corbin

Recruiting

Corbin, Kentucky, United States, 40701

Contacts

Site Public Contact

859-523-1934

Principal Investigator:

Firas B. Badin

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Site Public Contact

859-260-6425

Principal Investigator:

Firas B. Badin

Baptist Health Hamburg

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Site Public Contact

866-213-3025

Principal Investigator:

Firas B. Badin

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Samuel Rosner

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Principal Investigator:

Jacob M. Elkon

Lahey Hospital and Medical Center

Recruiting

Burlington, Massachusetts, United States, 01805

Contacts

Principal Investigator:

Fei Song

Lahey Medical Center-Peabody

Recruiting

Peabody, Massachusetts, United States, 01960

Contacts

Principal Investigator:

Fei Song

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Health Saint John Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford River District Hospital

Recruiting

East China Township, Michigan, United States, 48054

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Academic

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Breast

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Van Elslander

Recruiting

Grosse Pointe Woods, Michigan, United States, 48236

Contacts

Principal Investigator:

Elie G. Dib

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Warren Hospital - Breast Macomb

Recruiting

Macomb, Michigan, United States, 48044

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Health Warren Hospital

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Madison Heights Hospital - Breast

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Elie G. Dib

Henry Ford Warren Hospital - GLCMS

Recruiting

Warren, Michigan, United States, 48093

Contacts

Principal Investigator:

Elie G. Dib

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Principal Investigator:

Elie G. Dib

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Principal Investigator:

Daniel Almquist

Essentia Health Saint Joseph's Medical Center

Recruiting

Brainerd, Minnesota, United States, 56401

Contacts

Principal Investigator:

Bret E. Friday

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Principal Investigator:

David M. King

Essentia Health - Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Principal Investigator:

Bret E. Friday

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

David M. King

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Site Public Contact

218-786-3308

Principal Investigator:

Bret E. Friday

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Principal Investigator:

David M. King

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

David M. King

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Principal Investigator:

David M. King

New Ulm Medical Center

Recruiting

New Ulm, Minnesota, United States, 56073

Contacts

Principal Investigator:

David M. King

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

David M. King

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Principal Investigator:

David M. King

United Hospital

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Principal Investigator:

David M. King

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Principal Investigator:

Bret E. Friday

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Principal Investigator:

Bret E. Friday

University of Kansas Cancer Center - Briarcliff

Recruiting

Kansas City, Missouri, United States, 64116

Contacts

Site Public Contact

913-588-3671

Principal Investigator:

Anusha Chidharla

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Principal Investigator:

Anusha Chidharla

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Principal Investigator:

Anusha Chidharla

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Principal Investigator:

Jay W. Carlson

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Principal Investigator:

John M. Schallenkamp

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Prantesh Jain

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Megan A. Baumgart

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Principal Investigator:

Megan A. Baumgart

FirstHealth of the Carolinas-Moore Regional Hospital

Recruiting

Pinehurst, North Carolina, United States, 28374

Contacts

Principal Investigator:

Charles S. Kuzma

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Principal Investigator:

Daniel Almquist

Essentia Health Cancer Center-South University Clinic

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

Principal Investigator:

Bret E. Friday

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Aultman Health Foundation

Recruiting

Canton, Ohio, United States, 44710

Contacts

Principal Investigator:

Raza A. Khan

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Principal Investigator:

Tarek M. Sabagh

Premier Blood and Cancer Center

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-276-8320

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital North

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Principal Investigator:

Tarek M. Sabagh

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005-1066

Contacts

Principal Investigator:

Tarek M. Sabagh

Miami Valley Cancer Care and Infusion

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Site Public Contact

937-569-7515

Principal Investigator:

Tarek M. Sabagh

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Principal Investigator:

Tarek M. Sabagh

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Nirmal Choradia

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Principal Investigator:

Charles W. Drescher

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Principal Investigator:

Charles W. Drescher

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Charles W. Drescher

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Principal Investigator:

Charles W. Drescher

Saint Joseph's/Candler - Bluffton Campus

Recruiting

Bluffton, South Carolina, United States, 29910

Contacts

Principal Investigator:

Mark A. Taylor

Prisma Health Cancer Institute - Spartanburg

Recruiting

Boiling Springs, South Carolina, United States, 29316

Contacts

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, United States, 29640

Contacts

Principal Investigator:

Ki Y. Chung

Tidelands Georgetown Memorial Hospital

Recruiting

Georgetown, South Carolina, United States, 29440

Contacts

Principal Investigator:

Mariam Alexander

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Greer

Recruiting

Greer, South Carolina, United States, 29650

Contacts

Principal Investigator:

Ki Y. Chung

Prisma Health Cancer Institute - Seneca

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

Principal Investigator:

Ki Y. Chung

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Principal Investigator:

Daniel Almquist

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Carl M. Gay

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

Jonathan D. Berkman

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Jonathan D. Berkman

VCU Community Memorial Health Center

Recruiting

South Hill, Virginia, United States, 23970

Contacts

Principal Investigator:

Jonathan D. Berkman

VCU Health Tappahannock Hospital

Recruiting

Tappahannock, Virginia, United States, 22560

Contacts

Site Public Contact

klcampbell@vcu.edu

Principal Investigator:

Jonathan D. Berkman

Duluth Clinic Ashland

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Principal Investigator:

Bret E. Friday

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Principal Investigator:

David E. Marinier

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

Mar 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-03-30.