Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial

NCT ID: NCT06096844

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-19

Study Completion Date

2026-06-01

Brief Summary

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This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Detailed Description

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PRIMARY OBJECTIVE:

I. To evaluate whether there is an improvement in overall survival (OS) with chemotherapy combined with pembrolizumab compared to single agent pembrolizumab in this vulnerable older adult patient population.

SECONDARY OBJECTIVES:

I. To evaluate any difference in progression free survival (PFS) with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab.

II. To evaluate the difference in PFS rate at 3 months and at 6 months with chemotherapy combined with pembrolizumab as compared to single agent pembrolizumab.

III. To evaluate the difference in best objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria to assess whether chemotherapy combined with pembrolizumab results in improved response rates compared to treatment with single agent pembrolizumab.

IV. To evaluate toxicity in those treated with chemotherapy combined with pembrolizumab compared to those treated with single agent pembrolizumab.

V. To evaluate patient reported quality of life (QOL) evaluations between treatment arms.

EXPLORATORY OBJECTIVES:

I. To compare safety and tolerability between treatment arms. II. To explore factors within the pre-treatment geriatric assessment (GA) as predictors of toxicity and outcomes. To describe changes between the intended chemotherapy treatment planned versus treatment given and referrals placed by treating provider based on GA results.

III. To evaluate the assessment of a novel, composite fPFS score using disease progression/functional impairment assessment as a potential correlate to OS in this vulnerable population.

IV. To evaluate the correlation of 3-months PFS with OS as a potential surrogate of OS benefit.

V. To evaluate the correlation of 6-months PFS with OS as a potential surrogate of OS benefit.

VI. To assess elective dose intensity of chemotherapy of patients who receive doublet chemotherapy versus single agent chemotherapy.

EXPLORATORY CORRELATIVE OBJECTIVE:

I. To relate gut microbe abundances to treatment outcomes, toxicity, and geriatric assessments.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A:

INDUCTION: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity.

ARM B:

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Patients also receive investigator's choice of a chemotherapy regimen: 1) Pemetrexed IV over 10 minutes + carboplatin IV over 30-60 minutes on day 1 of each cycle; 2) Nab-paclitaxel IV over 30 on days 1, 8, and 15 of each cycle + carboplatin IV over 30-60 minutes on day 1 of each cycle; 3) Paclitaxel IV over 1 hour on day 1, 8, and 15 of each cycle or over 3 hours on day 1 of each cycle + carboplatin IV over 30-60 minutes on day 1 of each cycle; 4) Nab-paclitaxel IV over 30 minutes on days 1, 8 and 15 of each cycle; 5) Paclitaxel IV over 3 hours on day 1 of each cycle or over 1 hour on days 1, 8, and 15 of each cycle; or 6) Pemetrexed IV over 10 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity.

All patients undergo magnetic resonance imaging (MRI) at baseline and computed tomography (CT) and/or positron emission tomography (PET) on the trial at baseline and throughout the trial.

After completion of study treatment, patients are followed up every 3 months if \< 2 years from randomization and every 6 months if 2-5 years from Step 1 registration.

Conditions

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Advanced Lung Non-Small Cell Carcinoma Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (pembrolizumab)

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo MRI at baseline and CT and/or PET on the trial at baseline and throughout the trial.

Group Type ACTIVE_COMPARATOR

Computed Tomography

Intervention Type PROCEDURE

Undergo CT scan

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Pembrolizumab

Intervention Type BIOLOGICAL

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm B (pembrolizumab, chemotherapy)

See Detailed Description

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

Given IV

Computed Tomography

Intervention Type PROCEDURE

Undergo CT scan

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Nab-paclitaxel

Intervention Type DRUG

Given IV

Paclitaxel

Intervention Type DRUG

Given IV

Pembrolizumab

Intervention Type BIOLOGICAL

Given IV

Pemetrexed

Intervention Type DRUG

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Carboplatin

Given IV

Intervention Type DRUG

Computed Tomography

Undergo CT scan

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Nab-paclitaxel

Given IV

Intervention Type DRUG

Paclitaxel

Given IV

Intervention Type DRUG

Pembrolizumab

Given IV

Intervention Type BIOLOGICAL

Pemetrexed

Given IV

Intervention Type DRUG

Positron Emission Tomography

Undergo PET

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatinum Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 JM8 Nealorin Novoplatinum Paraplatin Paraplatin AQ Paraplatine Platinwas Ribocarbo 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 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 ABI 007 ABI-007 ABI007 Abraxane Albumin-bound Paclitaxel Albumin-Stabilized Nanoparticle Paclitaxel Nanoparticle Albumin-bound Paclitaxel Nanoparticle Paclitaxel Naveruclif Paclitaxel Albumin paclitaxel albumin-stabilized nanoparticle formulation Paclitaxel Nanoparticle Albumin-bound Paclitaxel Protein-Bound Protein-bound Paclitaxel Anzatax Asotax Bristaxol Praxel Taxol Taxol Konzentrat BCD-201 GME 751 GME751 Keytruda Lambrolizumab MK 3475 MK-3475 MK3475 Pembrolizumab Biosimilar BCD-201 Pembrolizumab Biosimilar GME751 Pembrolizumab Biosimilar QL2107 Pembrolizumab Biosimilar RPH-075 Pembrolizumab Biosimilar SB27 QL2107 RPH 075 RPH-075 RPH075 SB 27 SB-27 SB27 SCH 900475 SCH-900475 SCH900475 MTA Multitargeted Antifolate Pemfexy Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT

Eligibility Criteria

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Inclusion Criteria

* STEP 1 REGISTRATION
* Patient must be ≥ 70 years of age
* Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%
* Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed
* Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors
* Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2
* Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration)
* Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration)
* Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration)
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)
* Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)
* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patient must be English or Spanish speaking to be eligible for the QOL component of the study

* NOTE: Sites cannot translate the associated GA or QOL forms
* Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible
* Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration
* Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration
* Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease
* Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible
* Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration
* Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet)
* STEP 2 RANDOMIZATION
* Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Megan A Baumgart

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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SIH Cancer Institute

Carterville, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, United States

Site Status RECRUITING

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, United States

Site Status RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group - Rogers

Rogers, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status RECRUITING

Kaiser Permanente Dublin

Dublin, California, United States

Site Status RECRUITING

Kaiser Permanente-Fremont

Fremont, California, United States

Site Status RECRUITING

Kaiser Permanente Fresno Orchard Plaza

Fresno, California, United States

Site Status RECRUITING

Kaiser Permanente-Fresno

Fresno, California, United States

Site Status RECRUITING

Kaiser Permanente-Modesto

Modesto, California, United States

Site Status RECRUITING

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status RECRUITING

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status RECRUITING

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status RECRUITING

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente-South Sacramento

Sacramento, California, United States

Site Status RECRUITING

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status RECRUITING

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status RECRUITING

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Site Status RECRUITING

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status RECRUITING

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Site Status RECRUITING

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status RECRUITING

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status RECRUITING

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status RECRUITING

Stamford Hospital/Bennett Cancer Center

Stamford, Connecticut, United States

Site Status RECRUITING

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Malcom Randall Veterans Administration Medical Center

Gainesville, Florida, United States

Site Status RECRUITING

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Site Status RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

Site Status RECRUITING

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status SUSPENDED

Moffitt Cancer Center

Tampa, Florida, United States

Site Status SUSPENDED

Moffitt Cancer Center at Wesley Chapel

Wesley Chapel, Florida, United States

Site Status RECRUITING

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Site Status RECRUITING

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Site Status RECRUITING

Rush-Copley Medical Center

Aurora, Illinois, United States

Site Status RECRUITING

Advocate Good Shepherd Hospital

Barrington, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Advocate Sherman Hospital

Elgin, Illinois, United States

Site Status RECRUITING

Advocate South Suburban Hospital

Hazel Crest, Illinois, United States

Site Status RECRUITING

AMG Libertyville - Oncology

Libertyville, Illinois, United States

Site Status RECRUITING

Condell Memorial Hospital

Libertyville, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

Loyola University Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Site Status SUSPENDED

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Site Status RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status RECRUITING

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Site Status RECRUITING

Memorial Hospital East

Shiloh, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

Northwest Cancer Center - Main Campus

Crown Point, Indiana, United States

Site Status RECRUITING

Northwest Oncology LLC

Dyer, Indiana, United States

Site Status RECRUITING

Northwest Cancer Center - Hobart

Hobart, Indiana, United States

Site Status RECRUITING

Saint Mary Medical Center

Hobart, Indiana, United States

Site Status RECRUITING

Saint Catherine Hospital

Indianapolis, Indiana, United States

Site Status RECRUITING

The Community Hospital

Munster, Indiana, United States

Site Status RECRUITING

Women's Diagnostic Center - Munster

Munster, Indiana, United States

Site Status RECRUITING

Northwest Cancer Center - Valparaiso

Valparaiso, Indiana, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Site Status RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status RECRUITING

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

Clive, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Site Status RECRUITING

University of Kansas Clinical Research Center

Fairway, Kansas, United States

Site Status RECRUITING

HaysMed

Hays, Kansas, United States

Site Status RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, United States

Site Status RECRUITING

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status SUSPENDED

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, United States

Site Status RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

Site Status RECRUITING

Salina Regional Health Center

Salina, Kansas, United States

Site Status RECRUITING

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

Site Status RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status RECRUITING

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status RECRUITING

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Site Status RECRUITING

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

Site Status RECRUITING

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

William E Kahlert Regional Cancer Center/Sinai Hospital

Westminster, Maryland, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute at Boston Medical Center - Brighton

Brighton, Massachusetts, United States

Site Status RECRUITING

Dana-Farber Cancer Institute at Foxborough

Foxborough, Massachusetts, United States

Site Status RECRUITING

Dana Farber-Merrimack Valley

Methuen, Massachusetts, United States

Site Status RECRUITING

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

Milford, Massachusetts, United States

Site Status RECRUITING

Dana-Farber/Brigham and Women's Cancer Center at South Shore

South Weymouth, Massachusetts, United States

Site Status RECRUITING

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

Site Status SUSPENDED

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Site Status RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status SUSPENDED

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status RECRUITING

Hurley Medical Center

Flint, Michigan, United States

Site Status RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Site Status RECRUITING

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Site Status RECRUITING

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status RECRUITING

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Site Status RECRUITING

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Site Status RECRUITING

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status SUSPENDED

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status RECRUITING

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Site Status RECRUITING

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

Site Status RECRUITING

Munson Medical Center

Traverse City, Michigan, United States

Site Status RECRUITING

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status SUSPENDED

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status RECRUITING

Mayo Clinic Health Systems-Mankato

Mankato, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status RECRUITING

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

University Health Truman Medical Center

Kansas City, Missouri, United States

Site Status RECRUITING

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Site Status RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Mercy Hospital South

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status ACTIVE_NOT_RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Logan Health Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Community Medical Center

Missoula, Montana, United States

Site Status RECRUITING

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Site Status RECRUITING

The Dana-Farber Cancer Institute at Londonderry

Londonderry, New Hampshire, United States

Site Status RECRUITING

Jefferson Cherry Hill Hospital

Cherry Hill, New Jersey, United States

Site Status RECRUITING

Inspira Medical Center Mullica Hill

Mullica Hill, New Jersey, United States

Site Status SUSPENDED

Penn Medicine Princeton Health

Plainsboro, New Jersey, United States

Site Status RECRUITING

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, United States

Site Status RECRUITING

Glens Falls Hospital

Glens Falls, New York, United States

Site Status RECRUITING

Upstate Cancer Center at Oswego

Oswego, New York, United States

Site Status RECRUITING

University of Rochester

Rochester, New York, United States

Site Status RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, United States

Site Status RECRUITING

State University of New York Upstate Medical University

Syracuse, New York, United States

Site Status RECRUITING

SUNY Upstate Medical Center-Community Campus

Syracuse, New York, United States

Site Status RECRUITING

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status RECRUITING

Upstate Cancer Center at Verona

Verona, New York, United States

Site Status RECRUITING

Wilmot Cancer Institute at Webster

Webster, New York, United States

Site Status RECRUITING

Durham VA Medical Center

Durham, North Carolina, United States

Site Status RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status RECRUITING

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, United States

Site Status RECRUITING

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status RECRUITING

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Site Status RECRUITING

Aultman Health Foundation

Canton, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status RECRUITING

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status RECRUITING

Case Western Reserve University

Cleveland, Ohio, United States

Site Status RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital

Dayton, Ohio, United States

Site Status RECRUITING

Premier Blood and Cancer Center

Dayton, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status RECRUITING

Miami Valley Cancer Care and Infusion

Greenville, Ohio, United States

Site Status RECRUITING

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Site Status RECRUITING

Memorial Hospital

Marysville, Ohio, United States

Site Status RECRUITING

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, United States

Site Status RECRUITING

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status RECRUITING

Licking Memorial Hospital

Newark, Ohio, United States

Site Status RECRUITING

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Site Status RECRUITING

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status RECRUITING

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status RECRUITING

Upper Valley Medical Center

Troy, Ohio, United States

Site Status RECRUITING

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status RECRUITING

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Site Status RECRUITING

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Site Status RECRUITING

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status RECRUITING

Lancaster General Ann B Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

Site Status RECRUITING

Riddle Memorial Hospital

Media, Pennsylvania, United States

Site Status RECRUITING

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Site Status RECRUITING

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Reading Hospital McGlinn Cancer Institute at Phoenixville

Phoenixville, Pennsylvania, United States

Site Status RECRUITING

Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status RECRUITING

Reading Hospital

West Reading, Pennsylvania, United States

Site Status RECRUITING

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Site Status RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status RECRUITING

Ralph H Johnson VA Medical Center

Charleston, South Carolina, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status SUSPENDED

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status RECRUITING

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status RECRUITING

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States

Site Status RECRUITING

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States

Site Status RECRUITING

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, United States

Site Status RECRUITING

White River Junction Veteran Administration Medical Center

White River Junction, Vermont, United States

Site Status RECRUITING

University of Virginia Cancer Center

Charlottesville, Virginia, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

VCU Health Tappahannock Hospital

Tappahannock, Virginia, United States

Site Status RECRUITING

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Site Status RECRUITING

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Site Status RECRUITING

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status RECRUITING

Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

Site Status RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status RECRUITING

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

Site Status RECRUITING

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status RECRUITING

ThedaCare Cancer Care - Berlin

Berlin, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, United States

Site Status RECRUITING

Aurora Saint Luke's South Shore

Cudahy, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status RECRUITING

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

Site Status RECRUITING

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Site Status RECRUITING

Bellin Memorial Hospital

Green Bay, Wisconsin, United States

Site Status RECRUITING

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status RECRUITING

Mercyhealth Hospital and Cancer Center - Janesville

Janesville, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, United States

Site Status RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status RECRUITING

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Aspirus Medford Hospital

Medford, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Site Status RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status RECRUITING

ThedaCare Regional Medical Center - Neenah

Neenah, Wisconsin, United States

Site Status RECRUITING

ThedaCare Cancer Care - New London

New London, Wisconsin, United States

Site Status RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status RECRUITING

ThedaCare Cancer Care - Oshkosh

Oshkosh, Wisconsin, United States

Site Status RECRUITING

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Racine

Racine, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status RECRUITING

ThedaCare Cancer Care - Shawano

Shawano, Wisconsin, United States

Site Status RECRUITING

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Site Status RECRUITING

Vince Lombardi Cancer Clinic-Two Rivers

Two Rivers, Wisconsin, United States

Site Status RECRUITING

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status RECRUITING

ThedaCare Cancer Care - Waupaca

Waupaca, Wisconsin, United States

Site Status RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status RECRUITING

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Site Status RECRUITING

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2023-08628

Identifier Type: REGISTRY

Identifier Source: secondary_id

EA5221

Identifier Type: OTHER

Identifier Source: secondary_id

EA5221

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2023-08628

Identifier Type: -

Identifier Source: org_study_id