Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

Trial Title: Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)

NCT ID: NCT06074588

Condition: Non-small Cell Lung Cancer (NSCLC)

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Docetaxel
Pemetrexed

Conditions: Keywords:
Anaplastic lymphoma kinase (ALK)
Antibody-drug conjugate (ADC)
Epidermal growth factor receptor (EGFR)
Trophoblast cell-surface antigen 2 (TROP2)

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Sacituzumab tirumotecan
Description: 4 mg/kg of MK-sacituzumab tirumotecan by IV infusion
Arm group label: Sacituzumab tirumotecan

Other name: SKB264, MK-2870

Intervention type: Drug
Intervention name: Docetaxel
Description: 75 mg/m^2 of docetaxel by IV Infusion
Arm group label: Chemotherapy

Other name: TAXOTERE®

Intervention type: Drug
Intervention name: Pemetrexed
Description: 500 mg/m^2 of pemetrexed by IV infusion
Arm group label: Chemotherapy

Other name: ALIMTA®

Summary: The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Criteria for eligibility:
Criteria:
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations. - Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1. - Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI. - Measurable disease per RECIST 1.1 as assessed by the local site investigator. - Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided - Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline. - Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization. - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. - Have an ECOG performance status of 0 or 1 within 3 days before randomization. Exclusion Criteria: - Has predominantly squamous cell histology NSCLC. - Has mixed tumor(s) with small cell elements. - Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease. - Has Grade ≥2 peripheral neuropathy. - Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing. - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. - Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib). - Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization. - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. - Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. - Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention. - Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC). - Received prior treatment with a topoisomerase I-containing ADC. - Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration. - Known additional malignancy that is progressing or has required active treatment within the past 3 years. - Active infection requiring systemic therapy. - History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD. - Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks, and are off steroids 3 days prior to dosing with study medication. - HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. - Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mid Florida Hematology and Oncology Center ( Site 0005)

Address:
City: Orange City
Zip: 32763
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 407-353-1915

Facility:
Name: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)

Address:
City: Marietta
Zip: 30060
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 770-281-5100

Facility:
Name: Karmanos Cancer Institute ( Site 0018)

Address:
City: Detroit
Zip: 48201
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 412-425-4221

Facility:
Name: Hattiesburg Clinic Hematology/Oncology ( Site 0010)

Address:
City: Hattiesburg
Zip: 39401
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 601-261-1700

Facility:
Name: University Of Nebraska Medical Center ( Site 0011)

Address:
City: Omaha
Zip: 68198
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 443-858-4860

Facility:
Name: Capital Health Medical Center - Hopewell ( Site 0006)

Address:
City: Pennington
Zip: 08534
Country: United States

Status: Completed

Facility:
Name: University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)

Address:
City: Cincinnati
Zip: 45219
Country: United States

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 513-558-2153

Facility:
Name: St. George Private Hospital ( Site 3004)

Address:
City: Kogarah
Zip: 2217
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 91131920

Facility:
Name: Westmead Hospital-Department of Medical Oncology ( Site 3000)

Address:
City: Westmead
Zip: 2145
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 61403170371

Facility:
Name: Monash Health-Oncology Research ( Site 3001)

Address:
City: Clayton
Zip: 3168
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0421450499

Facility:
Name: Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003)

Address:
City: Melbourne
Zip: 3021
Country: Australia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 041554497

Facility:
Name: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447)

Address:
City: Natal
Zip: 59075-740
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 558440095595

Facility:
Name: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440)

Address:
City: Porto Alegre
Zip: 91350-200
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +5551993590437

Facility:
Name: Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444)

Address:
City: Barretos
Zip: 14784-400
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 551733216637

Facility:
Name: Hospital Paulistano-Americas Oncologia ( Site 0441)

Address:
City: Sao Paulo
Zip: 01321-001
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +5511944716385

Facility:
Name: A. C. Camargo Cancer Center-CAPEC ( Site 0442)

Address:
City: Sao Paulo
Zip: 01509-010
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +5511993607754

Facility:
Name: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0446)

Address:
City: Sao Paulo
Zip: 04014-002
Country: Brazil

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 551144500360

Facility:
Name: William Osler Health System ( Site 0205)

Address:
City: Brampton
Zip: L6R 3J7
Country: Canada

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 9054942120

Facility:
Name: Princess Margaret Cancer Centre ( Site 0204)

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 4169464645

Facility:
Name: Centro Investigacion Cancer James Lind ( Site 0513)

Address:
City: Temuco
Zip: 4780000
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56994443272

Facility:
Name: Clinica Universidad Catolica del Maule-Oncology ( Site 0501)

Address:
City: Talca
Zip: 3465584
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56981340385

Facility:
Name: Orlandi Oncologia-Oncology ( Site 0504)

Address:
City: Santiago
Zip: 7500713
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56992214787

Facility:
Name: FALP-UIDO ( Site 0509)

Address:
City: Santiago
Zip: 7500921
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 56224457254

Facility:
Name: Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0502)

Address:
City: Santiago
Zip: 8330032
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56963413803

Facility:
Name: Bradfordhill-Clinical Area ( Site 0507)

Address:
City: Santiago
Zip: 8420383
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56998744662

Facility:
Name: ONCOCENTRO APYS-ACEREY ( Site 0500)

Address:
City: Viña del Mar
Zip: 2520598
Country: Chile

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +56992369820

Facility:
Name: Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2810)

Address:
City: Beijing
Zip: 100142
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613521469355

Facility:
Name: Beijing Peking Union Medical College Hospital-pneumology department ( Site 2815)

Address:
City: Beijing
Zip: 100730
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 13911235467

Facility:
Name: Chongqing University Cancer Hospital-Medical Oncology ( Site 2814)

Address:
City: Chongqing
Zip: 400030
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8615923245950

Facility:
Name: Fujian Cancer Hospital ( Site 2819)

Address:
City: Fuzhou
Zip: 350014
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613675007687

Facility:
Name: The First Affiliated hospital of Xiamen University ( Site 2820)

Address:
City: Xiamen
Zip: 361003
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613860458889

Facility:
Name: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

Address:
City: Guangzhou
Zip: 510515
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8602062787110

Facility:
Name: Guangxi Medical University Cancer Hospital-Respiratory Oncology ( Site 2816)

Address:
City: Nanning
Zip: 530200
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 86 13977183708

Facility:
Name: Harbin Medical University Cancer Hospital-oncology of department ( Site 2807)

Address:
City: Harbin
Zip: 150081
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 13904505825

Facility:
Name: Henan Cancer Hospital-henan cancer hospital ( Site 2813)

Address:
City: Zhengzhou
Zip: 450000
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613783590691

Facility:
Name: Tongji Hospital Tongji Medical,Science & Technology ( Site 2805)

Address:
City: Wuhan
Zip: 430000
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 86 13212760751

Facility:
Name: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2806)

Address:
City: Wuhan
Zip: 430022
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 13986252286

Facility:
Name: Hubei Cancer Hospital ( Site 2809)

Address:
City: Wuhan
Zip: 430079
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +86 13407192282

Facility:
Name: The Second Xiangya Hospital of Central South University ( Site 2827)

Address:
City: Changsha
Zip: 410011
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 13975806788

Facility:
Name: Hunan Cancer Hospital-thoracic oncology II ( Site 2808)

Address:
City: Changsha
Zip: 410013
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613170419973

Facility:
Name: Nanjing Drum Tower Hospital ( Site 2812)

Address:
City: Nangjing
Zip: 210008
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 13813920964

Facility:
Name: The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2821)

Address:
City: Nanchang
Zip: 330006
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613767120022

Facility:
Name: Jilin Province Tumor Hospital-clinical research ( Site 2803)

Address:
City: Changchun
Zip: 132000
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613943012851

Facility:
Name: The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2817)

Address:
City: Xi'an
Zip: 710061
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613572101611

Facility:
Name: Jinan Central Hospital-oncology department ( Site 2802)

Address:
City: Jinan
Zip: 250013
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +86 18953116532

Facility:
Name: LinYi Cancer Hospital ( Site 2804)

Address:
City: Linyi
Zip: 276001
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +86 15963998868

Facility:
Name: Shanghai Chest Hospital-Oncology department ( Site 2800)

Address:
City: Shanghai
Zip: 200030
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613601813062

Facility:
Name: Fudan University Shanghai Cancer Center-Oncology ( Site 2811)

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613501623469

Facility:
Name: Sichuan Cancer hospital ( Site 2822)

Address:
City: Chengdu
Zip: 610042
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +8613880276636

Facility:
Name: Yunnan Province Cancer Hospital ( Site 2824)

Address:
City: Kunming
Zip: 650118
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +8613888876721

Facility:
Name: Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 2828)

Address:
City: Hangzhou
Zip: 310016
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8613588491264

Facility:
Name: Zhejiang Cancer Hospital ( Site 2829)

Address:
City: Hangzhou
Zip: 310022
Country: China

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8657188122188

Facility:
Name: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1100)

Address:
City: Brno
Zip: 656 53
Country: Czechia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 420543134008

Facility:
Name: Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 1103)

Address:
City: Ostrava
Zip: 703 00
Country: Czechia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 00420 595 633 400

Facility:
Name: Fakultni nemocnice Plzen ( Site 1104)

Address:
City: Pilsen
Zip: 305 99
Country: Czechia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 420377402238

Facility:
Name: Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 1102)

Address:
City: Olomouc
Zip: 779 00
Country: Czechia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 420588445657

Facility:
Name: Vseobecna fakultni nemocnice v Praze-Onkologicka klinika ( Site 1105)

Address:
City: Praha 2
Zip: 122 00
Country: Czechia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 420224962143

Facility:
Name: Institut Bergonié - Centre Régional de Lutte Contre Le Cance-Medical Oncology ( Site 1303)

Address:
City: Bordeaux
Zip: 33076
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 33556333229

Facility:
Name: CENTRE LEON BERARD ( Site 1305)

Address:
City: Lyon Cedex08
Zip: 69373
Country: France

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 33426556761

Facility:
Name: Klinikum Chemnitz - Flemmingstraße ( Site 1401)

Address:
City: Chemnitz
Zip: 09116
Country: Germany

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 4937133343550

Facility:
Name: Errikos Dunant Hospital Center-Fourth Department of Oncology and Clinical Trials Unit ( Site 2705)

Address:
City: Athens
Zip: 115 26
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +306983519989

Facility:
Name: THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA"-3rd Dept of Internal Medicine and Laboratory, Oncol

Address:
City: Athens
Zip: 115 27
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 302107700220

Facility:
Name: ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 2704)

Address:
City: Chaidari, Athens
Zip: 124 62
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +302105831687

Facility:
Name: "Theagenio" Cancer Hospital of Thessaloniki ( Site 2703)

Address:
City: Thessaloniki
Zip: 540 07
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +30-2310-898606

Facility:
Name: Papageorgiou General Hospital of Thessaloniki ( Site 2701)

Address:
City: Thessaloniki
Zip: 564 29
Country: Greece

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 306942608228

Facility:
Name: Hong Kong Integrated Oncology Centre ( Site 3200)

Address:
City: Central
Zip: 0000
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 85237006888

Facility:
Name: Queen Mary Hospital ( Site 3203)

Address:
City: Hksar
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 39103339

Facility:
Name: Queen Elizabeth Hospital-Department of Clinical Oncology ( Site 3204)

Address:
City: Kowloon
Zip: 999077
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +85235066255

Facility:
Name: Princess Margaret Hospital-Department of Oncology ( Site 3201)

Address:
City: Lai Chi Kok
Zip: 55555
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 85229902803

Facility:
Name: Rambam Health Care Campus-Oncology Division ( Site 1702)

Address:
City: Haifa
Zip: 3109601
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 97247776700

Facility:
Name: Shaare Zedek Medical Center ( Site 1700)

Address:
City: Jerusalem
Zip: 9103102
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +972587040620

Facility:
Name: Rabin Medical Center ( Site 1703)

Address:
City: Petah Tikva
Zip: 4941492
Country: Israel

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 054-2531539

Facility:
Name: IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 18

Address:
City: Meldola
Zip: 47014
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +393487469100

Facility:
Name: Istituto Clinico Humanitas ( Site 1803)

Address:
City: Rozzano
Zip: 20089
Country: Italy

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +390282247730

Facility:
Name: Aichi Cancer Center Hospital ( Site 3400)

Address:
City: Nagoya
Zip: 464-8681
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-52-762-6111

Facility:
Name: National Cancer Center Hospital East ( Site 3406)

Address:
City: Kashiwa
Zip: 277-8577
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-4-7133-1111

Facility:
Name: National Hospital Organization Shikoku Cancer Center ( Site 3415)

Address:
City: Matsuyama
Zip: 791-0280
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-89-999-1111

Facility:
Name: Gunma Prefectural Cancer Center ( Site 3418)

Address:
City: Otashi
Zip: 373-8550
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-276-38-0771

Facility:
Name: Takarazuka City Hospital ( Site 3409)

Address:
City: Takarazuka
Zip: 665-0827
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-797-87-1161

Facility:
Name: Kanazawa University Hospital-Pulmonology ( Site 3414)

Address:
City: Kanazawa
Zip: 920-8641
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-76-265-2000

Facility:
Name: Kanagawa cancer center-Department of Thoracic Oncology ( Site 3404)

Address:
City: Yokohama
Zip: 241-8515
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-45-520-2222

Facility:
Name: Miyagi Cancer Center-Department of Respiratory Medicine ( Site 3416)

Address:
City: Natori
Zip: 981-1293
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-22-384-3151

Facility:
Name: Sendai Kousei Hospital ( Site 3401)

Address:
City: Sendai
Zip: 981-0914
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-22-728-8000

Facility:
Name: Kansai Medical University Hospital ( Site 3410)

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-72-804-0101

Facility:
Name: Shizuoka Cancer Center ( Site 3403)

Address:
City: Nagaizumi-cho,Sunto-gun
Zip: 411-8777
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-55-989-5222

Facility:
Name: The Cancer Institute Hospital of JFCR ( Site 3402)

Address:
City: Koto
Zip: 135-8550
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-3-3520-0111

Facility:
Name: National Hospital Organization Kyushu Medical Center ( Site 3412)

Address:
City: Fukuoka
Zip: 810-8563
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-92-852-0700

Facility:
Name: Kyushu University Hospital ( Site 3407)

Address:
City: Fukuoka
Zip: 812-8582
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-92-641-1151

Facility:
Name: Okayama University Hospital ( Site 3417)

Address:
City: Okayama
Zip: 700-8558
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-86-223-7151

Facility:
Name: Osaka International Cancer Institute ( Site 3413)

Address:
City: Osaka
Zip: 541-8567
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-6-6945-1181

Facility:
Name: Nippon Medical School Hospital ( Site 3408)

Address:
City: Tokyo
Zip: 113-8603
Country: Japan

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +81-3-3822-2131

Facility:
Name: Chungbuk National University Hospital-Internal medicine ( Site 3809)

Address:
City: Cheongju-si
Zip: 28644
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82432696015

Facility:
Name: Chonnam National University Hwasun Hospital-Pulmonology ( Site 3807)

Address:
City: Hwasun
Zip: 58128
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82 10 3635 2876

Facility:
Name: National Cancer Center-Lung Cancer Center ( Site 3810)

Address:
City: Goyang-si
Zip: 10408
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82319201694

Facility:
Name: Seoul National University Bundang Hospital ( Site 3806)

Address:
City: Seongnam
Zip: 13620
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +82-31-787-7041

Facility:
Name: The Catholic University Of Korea St. Vincent's Hospital-Medical Oncology ( Site 3803)

Address:
City: Suwon-si
Zip: 16247
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82312498153

Facility:
Name: Pusan National University Yangsan Hospital-Lung Cancer Clinic ( Site 3811)

Address:
City: Yangsan
Zip: 50612
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82-10-2870-9389

Facility:
Name: Pusan National University Hospital ( Site 3805)

Address:
City: Busan
Zip: 49241
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +82 51 240 7889

Facility:
Name: Chungnam national university hospital ( Site 3808)

Address:
City: Jung-gu
Zip: 35015
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82-42-280-8035

Facility:
Name: Kangbuk Samsung Hospital ( Site 3813)

Address:
City: Seoul
Zip: 03181
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 8222002082

Facility:
Name: Severance Hospital, Yonsei University Health System-Lung Cancer Center ( Site 3804)

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 821025203969

Facility:
Name: Konkuk University Medical Center ( Site 3812)

Address:
City: Seoul
Zip: 05030
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82-10-2676-0911

Facility:
Name: Asan Medical Center ( Site 3801)

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 821097929607

Facility:
Name: Samsung Medical Center-Division of Hematology/Oncology ( Site 3802)

Address:
City: Seoul
Zip: 06351
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 82234103438

Facility:
Name: Korea University Guro Hospital-Internal Medicine ( Site 3800)

Address:
City: Seoul
Zip: 08308
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 821022179216

Facility:
Name: Hospital Raja Perempuan Zainab II-Medical Department ( Site 3502)

Address:
City: Kota Bharu
Zip: 15586
Country: Malaysia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +019-9179838

Facility:
Name: National Cancer Institute-Radiotherapy and Oncology ( Site 3504)

Address:
City: Putrajaya
Zip: 62250
Country: Malaysia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 123304499

Facility:
Name: Sarawak General Hospital-Radiotherapy Unit ( Site 3500)

Address:
City: Kuching
Zip: 93586
Country: Malaysia

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +6010-9827539

Facility:
Name: CIO - Centro de Inmuno-Oncología de Occidente ( Site 0706)

Address:
City: Guadalajara
Zip: 44630
Country: Mexico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 3331721132

Facility:
Name: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Hematologia and Oncologia ( Site 0704)

Address:
City: Monterrey
Zip: 66460
Country: Mexico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5218180883663

Facility:
Name: Centro de Investigacion Clinica de Oaxaca ( Site 0701)

Address:
City: Oaxaca de Juarez
Zip: 68020
Country: Mexico

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 5525615891

Facility:
Name: Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 2009)

Address:
City: Torun
Zip: 87-100
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +48 56 679 33 90

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48225463066

Facility:
Name: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)

Address:
City: Przemysl
Zip: 37-700
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 661957237

Facility:
Name: Narodowy Instytut Onkologii - Oddzial w Gliwicach-II Klinika Radioterapi i Chemioterapii ( Site 2002

Address:
City: Gliwice
Zip: 44-102
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48322788819

Facility:
Name: Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 2005)

Address:
City: Kielce
Zip: 25-734
Country: Poland

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 48793755188

Facility:
Name: HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Sit

Address:
City: Barcelona
Zip: 08036
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 93 227 54 00

Facility:
Name: Hospital Insular de Gran Canaria-Oncology ( Site 2305)

Address:
City: Las Palmas de Gran Canaria
Zip: 35016
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +34 928441738

Facility:
Name: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2303)

Address:
City: Madrid
Zip: 28009
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +34915868115

Facility:
Name: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2301)

Address:
City: Pozuelo de Alarcon
Zip: 28223
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 34914521987

Facility:
Name: H.R.U Málaga - Hospital General-Oncology ( Site 2302)

Address:
City: Málaga
Zip: 29011
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 00349422033350000

Facility:
Name: Clinica Universidad de Navarra-Medical Oncology ( Site 2306)

Address:
City: Madrid
Zip: 28027
Country: Spain

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +34913531920

Facility:
Name: Faculty of Medicine Siriraj Hospital ( Site 4000)

Address:
City: Bangkok
Zip: 10700
Country: Thailand

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 6624194488

Facility:
Name: Songklanagarind hospital ( Site 4001)

Address:
City: HatYai
Zip: 90110
Country: Thailand

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 6674451469

Facility:
Name: Maharaj Nakorn Chiang Mai Hospital ( Site 4003)

Address:
City: Chiang Mai
Zip: 50200
Country: Thailand

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 6653935480

Facility:
Name: Faculty of Medicine - Khon Kaen University ( Site 4004)

Address:
City: Khon Kaen
Zip: 40002
Country: Thailand

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 66840292822

Facility:
Name: Medipol Mega Universite Hastanesi-oncology ( Site 2505)

Address:
City: Stanbul
Zip: 34214
Country: Turkey

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 905325280486

Facility:
Name: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)

Address:
City: Ankara
Zip: 06230
Country: Turkey

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: +905334318506

Facility:
Name: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 2501)

Address:
City: Ankara
Zip: 06800
Country: Turkey

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 905555306271

Facility:
Name: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)

Address:
City: Istanbul
Zip: 34722
Country: Turkey

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 00905063509061

Facility:
Name: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2606)

Address:
City: London
Zip: SW3 6JJ
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 442086613278

Facility:
Name: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2600)

Address:
City: London
Zip: EC1A 7BE
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 447854094052

Facility:
Name: Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 2603)

Address:
City: London
Zip: SE1 9RT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 02071882006

Facility:
Name: Royal Marsden Hospital (Sutton) ( Site 2605)

Address:
City: London
Zip: SM2 5PT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 442086613278

Facility:
Name: The Clatterbridge Cancer Centre ( Site 2602)

Address:
City: Wirral
Zip: CH63 4JY
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0151 556 5000

Facility:
Name: Hanoi Oncology Hospital ( Site 4102)

Address:
City: Hanoi
Zip: 100000
Country: Vietnam

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0913247525

Facility:
Name: K Hospital - National Cancer Hospital ( Site 4105)

Address:
City: Hanoi
Zip: 100000
Country: Vietnam

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 84989743185

Facility:
Name: National Lung Hospital-Oncology Department ( Site 4104)

Address:
City: Hanoi
Zip: 100000
Country: Vietnam

Status: Recruiting

Contact:
Last name: Study Coordinator

Phone: 0904791162

Start date: November 12, 2023

Completion date: March 11, 2030

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06074588
http://www.merckclinicaltrials.com
https://msd.trialsummaries.com/Study/StudyDetails?id=26168&tenant=MT_MSD_9011