Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Last updated: October 22, 2025
Sponsor: Mirati Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Neoplasms

Neoplasm Metastasis

Lung Cancer

Treatment

Adagrasib

Clinical Study ID

NCT05853575
CA239-0012
CA239-0012
849-021
2023-503523-25
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Are at least 18 years old (or old enough to legally make their own treatmentdecisions, according to local laws).

  • Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and thenspread to other parts of the body) with the KRAS G12C mutation.

  • Have had previous treatment with 1) chemotherapy that included a drug calledcisplatin or a drug called carboplatin and 2) a type of drug called an immunecheckpoint inhibitor.

  • Have recovered from their prior treatment and blood tests are within a safe range.

Exclusion

Key Exclusion Criteria:

  • Have had previous treatment with a drug that targets KRAS G12C.

  • Have cancer that can potentially be removed with surgery.

  • Patients with brain lesions are not eligible if 1) any untreated brain lesions are > 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing >10 mgdaily prednisone (or equivalent) and 4) poorly controlled (> 1/week) generalized orcomplex partial seizures or neurologic progression/instability due to brain lesions.

  • Have certain medical conditions or need to take certain medications that, in theopinion of a trial doctor, could make it unsafe for them to participate or difficultto complete the trial assessments, or are pregnant.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Adagrasib
Phase: 2
Study Start date:
February 16, 2024
Estimated Completion Date:
July 30, 2026

Study Description

CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.

Connect with a study center

  • Ensino e Terapia de Inovação Clinica AMO-ÉTICA / Ética Pesquisa e Ensino

    Salvador, Bahia 41950-640
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    Cachoeiro Do Itapemirim, Espírito Santo 29308-065
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    Site Not Available

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    Cachoeiro Do Itapemirim, Espírito Santo 29308-065
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    Salvador 3450554, Estado de Bahia 3471168 41950-640
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    Belo Horizonte, Minas Gerais 30360680
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  • Oncocentro de Minas Gerais

    Belo Horizonte, Minas Gerais 30360680
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  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande Do Sul 90610-000
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    Porto Alegre, Rio Grande Do Sul 90610-000
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  • Uniao Brasileira de Educacao E Assistencia

    Porto Alegre, Rio Grande Do Sul 90610-000
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  • Uniao Brasileira de Educacao E Assistencia

    Porto Alegre 3452925, Rio Grande do Sul 3451133 90610-000
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  • Catarina Pesquisa Clinica

    Itajaí, Santa Catarina 88301-220
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    Itajaí, Santa Catarina 88301-220
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    Itajaí, Santa Catarina 88301-220
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    Itajaí 3460845, Santa Catarina 3450387 88301-220
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    São Paulo, 01509-900
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    Saint-Herblain Cedex, Loire-Atlantique 44800
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    Angers, Maine-et-Loire 49933
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    Saint-Mandé, 94163
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    Szolnok 715126, Jász-Nagykun-Szolnok 719637 H-5000
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    Jerusalem, Yerushalayim 9103102
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    Site Not Available

  • Ovidius Clinical Hospital

    Ovidiu 671584, Constanța County 680962 905900
    Romania

    Active - Recruiting

  • Centrul de Oncologie Sf Nectarie - Medical Oncology

    Craiova, Dolj 200746
    Romania

    Site Not Available

  • Centrul de Oncologie Sf. Nectarie

    Craiova, Dolj 200542
    Romania

    Active - Recruiting

  • Local Institution - 727

    Craiova, Dolj 200094
    Romania

    Site Not Available

  • Local Institution - 729

    Craiova, Dolj 200385
    Romania

    Site Not Available

  • Local Institution - 734

    Craiova, Dolj 200542
    Romania

    Site Not Available

  • Oncolab

    Craiova, Dolj 200385
    Romania

    Active - Recruiting

  • Oncolab - Medical Oncology

    Craiova, Dolj 200385
    Romania

    Active - Recruiting

  • Centrul de Oncologie Sf Nectarie - Medical Oncology

    Craiova 680332, Dolj 679134 200746
    Romania

    Active - Recruiting

  • Local Institution - 727

    Craiova 680332, Dolj 679134 200094
    Romania

    Site Not Available

  • Oncolab - Medical Oncology

    Craiova 680332, Dolj 679134 200385
    Romania

    Active - Recruiting

  • Local Institution - 730

    Timisoara, Timis 300166
    Romania

    Site Not Available

  • Oncocenter- Oncologie Clinica - Medical Oncology

    Timisoara, Timis 300166
    Romania

    Site Not Available

  • Oncocenter-Oncologie Clinica

    Timisoara, Timis 300166
    Romania

    Active - Recruiting

  • Oncocenter- Oncologie Clinica - Medical Oncology

    Timișoara 665087, Timiș County 665091 300166
    Romania

    Active - Recruiting

  • Local Institution - 726

    Bucharest 683506, 022328
    Romania

    Site Not Available

  • Local Institution - 726

    Bucuresti, 022328
    Romania

    Site Not Available

  • Centrul de Oncologie Euroclinic

    Iasi, 700106
    Romania

    Site Not Available

  • Local Institution - 733

    Iasi, 700106
    Romania

    Site Not Available

  • Centrul de Oncologie Euroclinic

    Iași 675810, 700106
    Romania

    Active - Recruiting

  • Local Institution - 725

    Sibiu, 550245
    Romania

    Site Not Available

  • Spitalul Clinic Judetean De Urgenta Sibiu

    Sibiu, 550245
    Romania

    Site Not Available

  • Spitalul Clinic Judetean De Urgenta Sibiu

    Sibiu 667268, 550245
    Romania

    Active - Recruiting

  • Local Institution - 127

    Suceava, 720214
    Romania

    Site Not Available

  • Local Institution - 728

    Suceava, 720214
    Romania

    Site Not Available

  • Sigmedical Services S.R.L.

    Suceava, 720214
    Romania

    Active - Recruiting

  • Sigmedical Services S.R.L.

    Suceava 665850, 720214
    Romania

    Active - Recruiting

  • Local Institution - 754

    Nis, Niaavski Okrug 18000
    Serbia

    Site Not Available

  • Local Institution - 403

    Nis, Vojvodina 11000
    Serbia

    Site Not Available

  • Local Institution - 750

    Sremska Kamenica, Vojvodina 21204
    Serbia

    Site Not Available

  • Local Institution - 750

    Kamenitz 3190104, Vojvodina 784272 21204
    Serbia

    Site Not Available

  • University Clinical Center of Nis, Clinic for Pediatrics-Department for Pulmonology

    Nis, Vojvodina 784272 11000
    Serbia

    Active - Recruiting

  • Local Institution - 752

    Kragujevac, Šumadijski Okrug 34000
    Serbia

    Site Not Available

  • University Clinical Center of Kragujevac, Center for Internal Oncology

    Kragujevac, Šumadijski Okrug 34000
    Serbia

    Site Not Available

  • University Clinical Center of Kragujevac, Center for Internal Oncology

    Kragujevac 789128, Šumadijski Okrug 34000
    Serbia

    Active - Recruiting

  • Local Institution - 751

    Belgrade, 11070
    Serbia

    Site Not Available

  • Local Institution - 753

    Belgrade, 11000
    Serbia

    Site Not Available

  • Local Institution - 751

    Belgrade 792680, 11070
    Serbia

    Site Not Available

  • Local Institution - 753

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • National Cancer Center

    Goyang-si 1842485, Gyeonggido [Kyonggi-do] 10408
    South Korea

    Active - Recruiting

  • Gangnam Severance Hospital - Oncology

    Seoul 1835848, Seoul Teugbyeolsi [Seoul-T'ukp 06273
    South Korea

    Active - Recruiting

  • Korea University Guro Hospital - Hematology-Oncology

    Seoul 1835848, Seoul Teugbyeolsi [Seoul-T'ukp 08308
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, Seoul Teugbyeolsi [Seoul-T'ukpyolshi] 6351
    South Korea

    Active - Recruiting

  • Complexo Hospitalario Universitario De Santiago

    Santiago De Compostela, A Coruña 15706
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario De Santiago - Oncología Médica

    Santiago de Compostela, A Coruña 15706
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario De Santiago - Oncología Médica

    Santiago de Compostela 3109642, A Coruña 15706
    Spain

    Active - Recruiting

  • Hospital Regional Universitario De Málaga

    Malaga, Andalucía 29010
    Spain

    Site Not Available

  • Local Institution - 678

    Malaga, Andalucía 29010
    Spain

    Site Not Available

  • Hospital Regional Universitario De Málaga

    Málaga 2514256, Andalusia 2593109 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Local Institution - 676

    Oviedo, Asturias 33011
    Spain

    Site Not Available

  • Hospital Universitario Son Espases

    Palma de Mallorca, Baleares 07120
    Spain

    Site Not Available

  • Local Institution - 685

    Palma de Mallorca, Baleares 7120
    Spain

    Site Not Available

  • Hospital Universitario Son Espases

    Palma de Mallorca 2512989, Balearic Islands 2521383 07120
    Spain

    Active - Recruiting

  • Local Institution - 686

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Local Institution - 686

    Santander 3109718, Cantabria 3336898 39008
    Spain

    Site Not Available

  • Hospital Universitario Central de Asturias

    Oviedo 3114711, Principality of Asturias 3114710 33011
    Spain

    Active - Recruiting

  • Local Institution - 684

    Valencia, Valenciana, Comunidad 46026
    Spain

    Site Not Available

  • Local Institution - 684

    Valencia 2509954, Valenciana, Comunidad 46026
    Spain

    Site Not Available

  • Hospital Universitari Dexeus Grupo Quironsalud

    Barcelona, 08028
    Spain

    Site Not Available

  • Hospital Universitari Vall D Hebron

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - Oncología Médica

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de La Santa Creu i Sant Pau

    Barcelona, 8041
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Local Institution - 681

    Barcelona, 8035
    Spain

    Site Not Available

  • Local Institution - 683

    Barcelona, 8041
    Spain

    Site Not Available

  • Local Institution - 687

    Barcelona, 8028
    Spain

    Site Not Available

  • Local Institution - 689

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Dexeus Grupo Quironsalud

    Barcelona 3128760, 08028
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron - Oncología Médica

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, 08025
    Spain

    Active - Recruiting

  • Local Institution - 689

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón - Oncología Médica

    Madrid, 28007
    Spain

    Site Not Available

  • Local Institution - 675

    Madrid, 28007
    Spain

    Site Not Available

  • Local Institution - 679

    Madrid, 28033
    Spain

    Site Not Available

  • Local Institution - 688

    Madrid, 28040
    Spain

    Site Not Available

  • M.D. Anderson Center Madrid

    Madrid, 28033
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid 3117735, 28007
    Spain

    Active - Recruiting

  • M.D. Anderson Center Madrid

    Madrid 3117735, 28033
    Spain

    Active - Recruiting

  • Hopital Universitario Virgen De La Macarena

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen De La Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Macarena - Oncología Médica

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Macarena - Oncología Médica

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario De Valencia - Oncologia Médica y Hematologia

    Valencia, 46010
    Spain

    Site Not Available

  • Local Institution - 677

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clinico Universitario De Valencia - Oncologia Médica y Hematologia

    Valencia 2509954, 46010
    Spain

    Active - Recruiting

  • Local Institution - 351

    Kaohsiung City, Kaohsiung 824005
    Taiwan

    Site Not Available

  • Local Institution - 352

    Kaohsuing City, Kaohsiung 83301
    Taiwan

    Site Not Available

  • Local Institution - 351

    Kaohsiung City 1673820, Kaohsiung 7280289 824005
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

    Kaohsuing City, Kaohsiung 7280289 833401
    Taiwan

    Active - Recruiting

  • China Medical University Hospital - Internal Medicine

    Taichung 1668399, Taichung 404327
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital - Internal Medicine

    Taichung 1668399, Taichung 402306
    Taiwan

    Active - Recruiting

  • Local Institution - 355

    Taichung 1668399, Taichung 407219
    Taiwan

    Site Not Available

  • China Medical University Hospital - Internal Medicine

    Taichung City, Taichung 404327
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital

    Taichung City, Taichung 40201
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital - Internal Medicine

    Taichung City, Taichung 402306
    Taiwan

    Site Not Available

  • Local Institution - 353

    Taichung City, Taichung 40201
    Taiwan

    Site Not Available

  • Local Institution - 355

    Taichung City, Taichung 407219
    Taiwan

    Site Not Available

  • Local Institution - 354

    Taipei City, Taipei 7280290 112201
    Taiwan

    Site Not Available

  • Local Institution - 376

    Muang, Chiang Mai 1153670 50200
    Thailand

    Site Not Available

  • Siriraj Hospital - Medical Oncology

    Bangkok, Krung Thep Maha Nakhon [Bangko 10700
    Thailand

    Site Not Available

  • Siriraj Hospital - Medical Oncology

    Bangkok 1609350, Krung Thep Maha Nakhon [Bangko 10700
    Thailand

    Active - Recruiting

  • Local Institution - 377

    Bangkok, Krung Thep Maha Nakhon [Bangkok] 10700
    Thailand

    Site Not Available

  • Siriraj Hospital

    Bangkok, Krung Thep Maha Nakhon [Bangkok] 10700
    Thailand

    Active - Recruiting

  • Local Institution - 376

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Local Institution - 375

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Srinagarind Hospital - ACADEMIC CLINICAL RESEARCH OFFICE

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Srinagarind Hospital - ACADEMIC CLINICAL RESEARCH OFFICE

    Khon Kaen 1609776, 40002
    Thailand

    Active - Recruiting

  • Holistic Center for Cancer Study and Care

    Songkhla, 90110
    Thailand

    Site Not Available

  • Local Institution - 378

    Songkhla, 90110
    Thailand

    Site Not Available

  • Holistic Center for Cancer Study and Care

    Songkhla 1606147, 90110
    Thailand

    Active - Recruiting

  • Memorial Ankara Hastanesi

    Ankara, Ankara/Cankaya 06520
    Turkey

    Site Not Available

  • Istanbul Oncology Hospital - Medical Oncology

    Istanbul, Samsun 34846
    Turkey

    Active - Recruiting

  • Local Institution - 703

    Istanbul, Samsun 34846
    Turkey

    Site Not Available

  • Medipol Mega Hospital

    Istanbul, Samsun 34214
    Turkey

    Active - Recruiting

  • Ankara Bilkent Sehir Hastanesi Tibbi Onkoloji Klinigi

    Ankara, 6800
    Turkey

    Active - Recruiting

  • Ankara City Hospital - Medical Oncology

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Ankara Liv Hospital

    Ankara, 06680
    Turkey

    Active - Recruiting

  • Ankara Liv Hospital Tibbi Onkoloji

    Ankara, 6680
    Turkey

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology

    Ankara, 06200
    Turkey

    Active - Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Ankara, 6200
    Turkey

    Active - Recruiting

  • Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi

    Ankara, 6010
    Turkey

    Active - Recruiting

  • Gulhane Egitim ve Arastirma Hastanesi tibbi Onkoloji Klinigi

    Ankara,
    Turkey

    Active - Recruiting

  • Gulhane Training and Research Hospital - Medical Oncology

    Ankara, 06010
    Turkey

    Active - Recruiting

  • Local Institution - 355

    Ankara, 06800
    Turkey

    Site Not Available

  • Local Institution - 706

    Ankara, 6800
    Turkey

    Site Not Available

  • Memorial Ankara Hastanesi Tibbi Onkoloji

    Ankara, 6520
    Turkey

    Active - Recruiting

  • Trakya Univ Hastanesi Ic Hastal

    Edirne, 22030
    Turkey

    Site Not Available

  • Trakya Universitesi Hastanesi Ic Hastaliklari Anabilim Dali Tibbi Onkoloji

    Edirne,
    Turkey

    Active - Recruiting

  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi Tibbi Onkoloji

    Istanbul,
    Turkey

    Active - Recruiting

  • Goztepe SuleymanYalcin Sehir Hast

    Istanbul, 34722
    Turkey

    Active - Recruiting

  • Istanbul Onkoloji Hastanesi Tibbi Onkoloji

    Istanbul, 34846
    Turkey

    Active - Recruiting

  • Local Institution - 709

    Istanbul, 34214
    Turkey

    Site Not Available

  • Medipol Mega Universite Hastanesi Tibbi Onkoloji

    Istanbul, 34214
    Turkey

    Active - Recruiting

  • Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722
    Turkey

    Active - Recruiting

  • Ege Universitesi Hastanesi Ic Hastaliklari Anabilim Dali Onkoloji Bilim Dali

    Izmir, 35100
    Turkey

    Active - Recruiting

  • Ege University Medical Faculty - Pulmonary

    Izmir, 35100
    Turkey

    Site Not Available

  • Local Institution - 708

    Izmir, 35100
    Turkey

    Site Not Available

  • Memorial Ankara Hastanesi

    Ankara 323786, Ankara/Cankaya 06520
    Turkey (Türkiye)

    Active - Recruiting

  • Gülhane Eğitim ve Araştırma Hastanesi

    Ankara 323786, Etlik/Ankara 06010
    Turkey (Türkiye)

    Active - Recruiting

  • Istanbul Oncology Hospital - Medical Oncology

    Istanbul, Samsun 740263 34846
    Turkey (Türkiye)

    Active - Recruiting

  • Local Institution - 703

    Istanbul, Samsun 740263 34846
    Turkey (Türkiye)

    Site Not Available

  • Medipol Mega Hospital

    Istanbul, Samsun 740263 34214
    Turkey (Türkiye)

    Active - Recruiting

  • Ankara City Hospital - Medical Oncology

    Ankara 323786, 06800
    Turkey (Türkiye)

    Active - Recruiting

  • Ankara Liv Hospital

    Ankara 323786, 06680
    Turkey (Türkiye)

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology

    Ankara 323786, 06200
    Turkey (Türkiye)

    Active - Recruiting

  • Trakya Univ Hastanesi Ic Hastal

    Edirne 747712, 22030
    Turkey (Türkiye)

    Active - Recruiting

  • Goztepe SuleymanYalcin Sehir Hast

    Istanbul 745044, 34722
    Turkey (Türkiye)

    Active - Recruiting

  • Ege University Medical Faculty - Pulmonary

    Izmir 311046, 35100
    Turkey (Türkiye)

    Active - Recruiting

  • Providence Medical Foundation

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Providence Medical Foundation - Research

    Santa Rosa, California 95403
    United States

    Site Not Available

  • Providence Medical Foundation - Research

    Santa Rosa 5393287, California 5332921 95403
    United States

    Active - Recruiting

  • Local Institution - 104

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Local Institution - 106

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Local Institution - 104

    Chicago 4887398, Illinois 4896861 60607
    United States

    Site Not Available

  • Local Institution - 103

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • Local Institution - 103

    Minneapolis 5037649, Minnesota 5037779 55417
    United States

    Site Not Available

  • Kansas City VA Hospital

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • Kansas City VA Medical Center

    Kansas City, Missouri 64128
    United States

    Active - Recruiting

  • Local Institution - 105

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • Kansas City VA Hospital

    Kansas City 4393217, Missouri 4398678 64128
    United States

    Active - Recruiting

  • Durham VA Medical Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Veterans Affairs Medical Center (VAMC) - Durham

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Veterans Affairs Medical Center (VAMC) - Durham - Oncology

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Veterans Affairs Medical Center (VAMC) - Durham - Oncology

    Durham 4464368, North Carolina 4482348 27705
    United States

    Active - Recruiting

  • VA North Texas Healthcare System/Dallas VA Medical Center

    Dallas, Texas 75216-7167
    United States

    Site Not Available

  • VA North Texas Healthcare System/Dallas VA Medical Center

    Dallas 4684888, Texas 4736286 75216-7167
    United States

    Active - Recruiting

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