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RecruitingNCT05058651Updated Oct 7, 2026

Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

A Phase 2/3 interventional study of Atezolizumab and Biospecimen Collection in Advanced Extrapulmonary Neuroendocrine Carcinoma, Metastatic Extrapulmonary Neuroendocrine Carcinoma and Recurrent Extrapulmonary Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI). Recruiting at 263 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by National Cancer Institute (NCI) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 3 months later.
Updated Oct 7, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.

Read the detailed description

PRIMARY OBJECTIVES:

I. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3).

II. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3).

III. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2).

SECONDARY OBJECTIVES:

I. To compare overall survival (OS), measured from start of observation/maintenance, across arms.

II. To compare progression free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms.

III. To compare objective response rate (ORR = confirmed and unconfirmed partial response [PR] + confirmed and unconfirmed complete response [CR]) across arms among patients with measurable disease at randomization.

IV. To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease [SD]) across arms among patients with measurable disease at randomization.

V. To compare duration of response (DOR) across arms. VI. To evaluate the safety and tolerability of each arm.

ADDITIONAL OBJECTIVE:

I. To bank tumor and blood samples for future biomarker correlative studies.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: During induction phase, patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 7/9/26): During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

ARM III: During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year.

Patients in all arms also undergo computed tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial and blood sample collection on study.

After completion of study treatment, patients are followed up for 5 years.

02

Conditions studied

  • Advanced Extrapulmonary Neuroendocrine Carcinoma
  • Metastatic Extrapulmonary Neuroendocrine Carcinoma
  • Recurrent Extrapulmonary Neuroendocrine Carcinoma
  • Unresectable Extrapulmonary Neuroendocrine Carcinoma
03

In context

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC)
  • Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator
  • Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and nonmeasurable lesions must be assessed by CT scan with IV contrast of the chest/abdomen/and pelvis (or CT chest without contrast and MRI abdomen/pelvis with gadolinium contrast, if contraindication to CT iodinated contrast) within 28 days prior to registration. While may be used for routine clinical evaluation, PET scans and bone scans alone are not acceptable for disease assessment while participating in this study. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form

  • Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) if clinically indicated within 28 days prior to registration. Note: Brain imaging is not required in participants without known and/or clinical concern for brain metastases. Participants with asymptomatic central nervous system (CNS) metastases are eligible if one or more of the following apply:

    • Participants who have received treatment for brain metastases must have:

      • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
      • Discontinued all corticosteroids at least 14 days prior to registration

    • Participants with treatment-naive brain lesions must have:

      • No lesion measuring > 2.0 cm in size in any axis
      • MRI brain or CT head with contrast (if there is contraindication to MRI brain) demonstrating no evidence for mass effect, edema, or other impending neurological compromise within 28 days prior to registration
      • No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration
      • No need for > 2 mg of dexamethasone (or equivalent of > 10 mg prednisone) per day at time of registration
  • Participants must not have symptomatic central nervous system (CNS) metastases
  • Participants must not have known or suspected leptomeningeal disease
  • Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated NEC may have had prior platinum-based therapy +/- radiation +/- surgery provided that all therapy was completed >= 6 months prior to registration
  • Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study
  • Participants must not have had prior treatment for advanced or metastatic NEC EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to registration. Other chemotherapy regimens are not allowed. For participants with prostate or urothelial NEC, prior chemotherapy for the non-NEC component (e.g. adenocarcinoma or urothelial) is allowed as long as such therapy was completed >= 24 weeks prior to registration and participants have recovered from all prior toxicities to =\< grade 1.
  • Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least 12 months prior to study registration
  • Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 [IL-2] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to registration
  • Participants must not have had history of known severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, including to Chinese hamster ovary cell products or to any component of the atezolizumab formulation, cisplatin, carboplatin, or etoposide
  • Participants must not be on active systemic therapy for another cancer with the exception of hormonal therapy including androgen deprivation therapy (e.g., gonadotropin-releasing hormone [GnRH] agonists or antagonists), which can be continued while participants are receiving protocol therapy. Use of enzalutamide or apalutamide is permitted after completion of chemotherapy and must be held during chemotherapy for participants receiving prior to enrollment. Use of darolutamide is permitted during chemotherapy. Glucocorticoid-containing regimens, including abiraterone, are not permitted.
  • Participants must be >= 18 years of age
  • Participants must have a Zubrod performance status of =\< 2 within 28 days prior to registration
  • Participants must have a complete medical history and physical exam within 28 days prior to registration
  • Absolute neutrophil count (ANC) >= 1.5 x 10\^9 /L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Hemoglobin >= 9.0 g/dl (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Platelet count >= 100 x 10\^9/L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Serum total bilirubin =\< 1.5 x ULN (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Adequate renal function as defined by any 1 of the following: 1) Measured creatinine clearance (CL) > 50 mL/min OR 2) Calculated creatinine CL > 50 mL/min by the Cockcroft-Gault formula OR by 24-hour urine collection for determination of creatinine clearance (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)
  • Participants must not have uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) within 14 days prior to registration. Participants who have asymptomatic hypercalcemia are eligible provided that medical therapy to treat the hypercalcemia is planned
  • Participants must not have a diagnosis of immunodeficiency nor be receiving systemic steroid therapy (equivalent of > 20 mg of hydrocortisone per day) or any other form of immunosuppressive therapy within 14 days prior to registration

  • Participants must not have active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:

    • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study
    • Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study

    • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

      • Rash must cover \< 10% of body surface area
      • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
      • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • Participants must not have history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • Participants must not have significant cardiovascular disease, such as New York Heart Association class II or greater cardiac disease, myocardial infarction within 3 months prior to registration, unstable arrythmias, or unstable angina
  • Participants must not have had a major surgical procedure other than for diagnosis within 28 days prior to registration. Participant must not plan to receive a major surgical procedure during the course of protocol treatment. NOTE: Patient port placement is not considered a major surgery
  • Participants must not have severe infections (i.e., Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) at time of registration, including but not limited to hospitalization for complications for infection, bacteremia, or severe pneumonia
  • Participants must not have known active tuberculosis
  • Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load, with testing performed as clinically indicated
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load, with testing performed as clinically indicated
  • Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months of registration
  • Participants must not have prior allogeneic bone marrow transplantation or solid organ transplant
  • Participants must not have received administration of a live, attenuated vaccine (e.g., FluMist [registered trademark]) within 28 days prior to initiation of study treatment, during treatment with atezolizumab, and not plan to receive for 5 months after the last dose of atezolizumab
  • Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method (with details provided as a part of the consent process) during the treatment period and for 5 months after the final dose of atezolizumab. 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 must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
189 participants (estimated)

Study arms

  • Experimental
    Arm I (atezolizumab, platinum drug, etoposide)

    During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.

    Biological: Atezolizumab · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Cisplatin · Procedure: Computed Tomography · Drug: Etoposide · Procedure: Magnetic Resonance Imaging

  • Experimental
    Arm II (atezolizumab, platinum drug, etoposide, observation)

    During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study. (CLOSED TO ACCRUAL 7/9/26)

    Biological: Atezolizumab · Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Cisplatin · Procedure: Computed Tomography · Drug: Etoposide · Procedure: Magnetic Resonance Imaging · Other: Patient Observation

  • Active comparator
    Arm III (platinum drug, etoposide, observation)

    During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.

    Procedure: Biospecimen Collection · Drug: Carboplatin · Drug: Cisplatin · Procedure: Computed Tomography · Drug: Etoposide · Procedure: Magnetic Resonance Imaging · Other: Patient Observation

Interventions

  • BiologicalAtezolizumab

    Given IV

    Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • DrugCarboplatin

    Given IV

    Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, JM8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

  • DrugCisplatin

    Given IV

    Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

  • ProcedureComputed Tomography

    Undergo CT scan

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • DrugEtoposide

    Given IV

    Also known as: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

  • OtherPatient Observation

    Undergo observation

    Also known as: Active Surveillance, deferred therapy, expectant management, Observation, Watchful Waiting

06

What researchers measure

Primary outcomes

  1. Overall survival

    Log-rank tests stratified by the randomization stratification factors will be used for null hypothesis (efficacy) tests. Cox regression models stratified by the randomization stratification factors will be used for alternative hypothesis (futility) tests.

    Time frame: From date of registration or from date of start of observation/maintenance therapy to date of death due to any cause, assessed up to 5 years

Secondary outcomes

  1. Progression-free survival

    Will be estimated using the Kaplan-Meier method and compared using log-rank tests.

    Time frame: From date of registration or start of observation/maintenance therapy to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years

  2. Duration of response

    Will be estimated non-parametrically using cumulative incidence curves.

    Time frame: Time from date of initial response to date of progression or death, assessed up to 5 years

  3. Objective response rate (confirmed complete response [CR] or partial response [PR])

    Will be tabulated and compared between arms using Fisher's exact test.

    Time frame: Up to 5 years from study enrollment

  4. Clinical benefit rate (confirmed CR or PR of any amount of time or stable disease for 6 months or longer)

    Will be tabulated and compared between arms using Fisher's exact test.

    Time frame: Up to 5 years from study enrollment

07

Study locations

240 of 263 sites recruiting
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
    Suspended
  • Cancer Center at Saint Joseph's
    Phoenix, Arizona 85004, United States
    Recruiting
  • Mayo Clinic Hospital in Arizona
    Phoenix, Arizona 85054, United States
    • Site Public Contact · Contact · 855-776-0015
    • Jacob Orme · Principal investigator
    Recruiting
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Sutter Auburn Faith Hospital
    Auburn, California 95602, United States
    Recruiting
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
    Auburn, California 95603, United States
    Recruiting
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
    Recruiting
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
    Cameron Park, California 95682, United States
    Recruiting
  • Mercy Cancer Center - Carmichael
    Carmichael, California 95608, United States
    Recruiting
  • Mercy San Juan Medical Center
    Carmichael, California 95608, United States
    Recruiting
  • Mercy Cancer Center - Elk Grove
    Elk Grove, California 95758, United States
    Recruiting
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Palo Alto Medical Foundation-Fremont
    Fremont, California 94538, United States
    Recruiting
  • Kaiser Permanente South Bay
    Harbor City, California 90710, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Memorial Medical Center
    Modesto, California 95355, United States
    Recruiting
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California 94040, United States
    Recruiting
  • Kaiser Permanente-Ontario
    Ontario, California 91761, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California 94301, United States
    Recruiting
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Mercy Cancer Center - Rocklin
    Rocklin, California 95765, United States
    Recruiting
  • Sutter Cancer Centers Radiation Oncology Services-Roseville
    Roseville, California 95661, United States
    Recruiting
  • Sutter Roseville Medical Center
    Roseville, California 95661, United States
    Recruiting
  • Mercy Cancer Center - Sacramento
    Sacramento, California 95816, United States
    Recruiting
  • Sutter Medical Center Sacramento
    Sacramento, California 95816, United States
    Recruiting
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94115, United States
    Recruiting
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • Palo Alto Medical Foundation-Santa Cruz
    Santa Cruz, California 95065, United States
    Recruiting
  • Sutter Pacific Medical Foundation
    Santa Rosa, California 95403, United States
    Recruiting
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California 94086, United States
    Recruiting
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California 94589, United States
    Recruiting
  • Woodland Memorial Hospital
    Woodland, California 95695, United States
    Recruiting
  • Kaiser Permanente-Woodland Hills
    Woodland Hills, California 91367, United States
    • Site Public Contact · Contact · clinical.trials@kp.org · 800-398-3996
    • Helen H. Moon · Principal investigator
    Recruiting
  • AdventHealth Porter
    Denver, Colorado 80210, United States
    Recruiting
  • AdventHealth Littleton
    Littleton, Colorado 80122, United States
    Recruiting
  • AdventHealth Parker
    Parker, Colorado 80138, United States
    Recruiting
  • Smilow Cancer Hospital-Derby Care Center
    Derby, Connecticut 06418, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center-Fairfield
    Fairfield, Connecticut 06824, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center at Glastonbury
    Glastonbury, Connecticut 06033, United States
    Suspended
  • Smilow Cancer Hospital Care Center at Greenwich
    Greenwich, Connecticut 06830, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center - Guilford
    Guilford, Connecticut 06437, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
    Suspended
  • Yale University
    New Haven, Connecticut 06520, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Yale-New Haven Hospital North Haven Medical Center
    North Haven, Connecticut 06473, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center at Long Ridge
    Stamford, Connecticut 06902, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital-Torrington Care Center
    Torrington, Connecticut 06790, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center-Trumbull
    Trumbull, Connecticut 06611, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital-Waterbury Care Center
    Waterbury, Connecticut 06708, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Smilow Cancer Hospital Care Center - Waterford
    Waterford, Connecticut 06385, United States
    • Site Public Contact · Contact · canceranswers@yale.edu · 203-785-5702
    • Matthew Austin · Principal investigator
    Recruiting
  • Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
    Recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
    • Site Public Contact · Contact · 855-776-0015
    • Jacob Orme · Principal investigator
    Recruiting
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
    Recruiting
  • Hawaii Cancer Care Inc - Waterfront Plaza
    Honolulu, Hawaii 96813, United States
    Recruiting
  • Queen's Cancer Cenrer - POB I
    Honolulu, Hawaii 96813, United States
    • Site Public Contact · Contact · 808-532-0315
    • Elizabeth S. Nakasone · Principal investigator
    Recruiting
  • Queen's Medical Center
    Honolulu, Hawaii 96813, United States
    • Site Public Contact · Contact · 808-545-8548
    • Elizabeth S. Nakasone · Principal investigator
    Recruiting
  • Straub Clinic and Hospital
    Honolulu, Hawaii 96813, United States
    • Site Public Contact · Contact · 808-522-4333
    • Elizabeth S. Nakasone · Principal investigator
    Recruiting
  • University of Hawaii Cancer Center
    Honolulu, Hawaii 96813, United States
    • Site Public Contact · Contact · 808-586-2979
    • Elizabeth S. Nakasone · Principal investigator
    Recruiting
  • Queen's Cancer Center - Kuakini
    Honolulu, Hawaii 96817, United States
    • Site Public Contact · Contact · 808-531-8521
    • Elizabeth S. Nakasone · Principal investigator
    Recruiting
  • Hawaii Cancer Care - Westridge
    ‘Aiea, Hawaii 96701, United States
    Recruiting
  • Pali Momi Medical Center
    ‘Aiea, Hawaii 96701, United States
    Suspended
  • The Queen's Medical Center - West Oahu
    ‘Ewa Beach, Hawaii 96706, United States
    • Site Public Contact · Contact · rohta@queens.org
    • Elizabeth S. Nakasone · Principal investigator
    Recruiting
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Saint Alphonsus Cancer Care Center-Nampa
    Nampa, Idaho 83687, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • Tareq Al baghdadi · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho 83864, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Rush-Copley Medical Center
    Aurora, Illinois 60504, United States
    Recruiting
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    Recruiting
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
    Recruiting
  • Carle at The Riverfront
    Danville, Illinois 61832, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Vamsi K. Vasireddy · Principal investigator
    Recruiting
  • Cancer Care Specialists of Illinois - Decatur
    Decatur, Illinois 62526, United States
    Recruiting
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee
    DeKalb, Illinois 60115, United States
    • Site Public Contact · Contact · Donald.Smith3@nm.org · 630-352-5360
    • Mary F. Mulcahy · Principal investigator
    Recruiting
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Vamsi K. Vasireddy · Principal investigator
    Recruiting
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
    Recruiting
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois 60134, United States
    • Site Public Contact · Contact · Donald.Smith3@nm.org · 630-352-5360
    • Mary F. Mulcahy · Principal investigator
    Recruiting
  • Northwestern Medicine Glenview Outpatient Center
    Glenview, Illinois 60026, United States
    • Site Public Contact · Contact · 312-695-1102
    • Mary F. Mulcahy · Principal investigator
    Recruiting
  • Northwestern Medicine Grayslake Outpatient Center
    Grayslake, Illinois 60030, United States
    • Site Public Contact · Contact · 312-695-1102
    • Mary F. Mulcahy · Principal investigator
    Recruiting
  • Ingalls Memorial Hospital
    Harvey, Illinois 60426, United States
    Recruiting
  • Northwestern Medicine Lake Forest Hospital
    Lake Forest, Illinois 60045, United States
    Recruiting
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Vamsi K. Vasireddy · Principal investigator
    Recruiting
  • SSM Health Good Samaritan
    Mount Vernon, Illinois 62864, United States
    Recruiting
  • UC Comprehensive Cancer Center at Silver Cross
    New Lenox, Illinois 60451, United States
    Recruiting
  • Carle BroMenn Medical Center
    Normal, Illinois 61761, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Vamsi K. Vasireddy · Principal investigator
    Recruiting
  • Carle Cancer Institute Normal
    Normal, Illinois 61761, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Vamsi K. Vasireddy · Principal investigator
    Recruiting
  • Cancer Care Center of O'Fallon
    O'Fallon, Illinois 62269, United States
    Recruiting
  • Northwestern Medicine Orland Park
    Orland Park, Illinois 60462, United States
    Recruiting
  • University of Chicago Medicine-Orland Park
    Orland Park, Illinois 60462, United States
    Recruiting
  • UW Health Carbone Cancer Center Rockford
    Rockford, Illinois 61114, United States
    • Site Public Contact · Contact · lkline@uwhealth.org · 779-696-9378
    • Fahrettin Covut · Principal investigator
    Recruiting
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 217-545-7929
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Clinic
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 800-444-7541
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Memorial Hospital
    Springfield, Illinois 62781, United States
    Recruiting
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Vamsi K. Vasireddy · Principal investigator
    Recruiting
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois 60555, United States
    • Site Public Contact · Contact · Donald.Smith3@nm.org · 630-352-5360
    • Mary F. Mulcahy · Principal investigator
    Recruiting

Showing the first 100 of 263 sites.

08

References and documents

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

No publications or documents are linked to this record.

09

Updates

3 registry updates since Sep 25, 2026
Status
Suspended→Recruiting Reason for stopping removed
changed Sep 30, 2026
Sites
8 sites added. 257 sites changed recruiting status
Show 8 added (8 United States)
  • Kootenai Health - Coeur d'Alene · Coeur d'Alene, United States
  • Kootenai Clinic Cancer Services - Post Falls · Post Falls, United States
  • Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, United States
  • SSM Health Good Samaritan · Mount Vernon, United States
  • Minnesota Oncology - Edina · Edina, United States
  • WellSpan Medical Oncology and Hematology · Hanover, United States
  • Billings Clinic Cancer Center · Billings, United States
  • Community Medical Center · Missoula, United States
across 3 updates, Sep 30, 2026 – Oct 7, 2026
Also revised
eligibility
Show all 3 updates
  1. Oct 7, 2026
    2 sites changed recruiting status
    + 1 other change: contact details
  2. Oct 5, 2026
    2 sites added
    Show 2 added (2 United States)
    • Billings Clinic Cancer Center · Billings, United States
    • Community Medical Center · Missoula, United States
  3. Sep 30, 2026
    Suspended→Recruiting
    Why stopped Reason for stopping removed
    6 sites added. 255 sites changed recruiting status
    Show 6 added (6 United States)
    • Kootenai Health - Coeur d'Alene · Coeur d'Alene, United States
    • Kootenai Clinic Cancer Services - Post Falls · Post Falls, United States
    • Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, United States
    • SSM Health Good Samaritan · Mount Vernon, United States
    • Minnesota Oncology - Edina · Edina, United States
    • WellSpan Medical Oncology and Hematology · Hanover, United States
    Eligibility Criteria revised
    + 5 other changes: identifiers, verification date, description, arm descriptions and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05058651
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 28, 2021
Start date
Jun 28, 2022
Primary completion
Oct 1, 2028 (estimated)
Completion
Oct 1, 2028 (estimated)
Last update
Oct 7, 2026

Study contacts

David B Zhen
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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