Trial Title:
Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)
NCT ID:
NCT06305754
Condition:
Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Acetaminophen
Dexamethasone
Dexamethasone acetate
Carboplatin
Pemetrexed
BB 1101
Histamine Antagonists
Histamine H1 Antagonists
Histamine H2 Antagonists
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
Unblinded Open-label
Intervention:
Intervention type:
Biological
Intervention name:
Sacituzumab tirumotecan
Description:
4 mg/kg via IV infusion
Arm group label:
Sacituzumab tirumotecan
Other name:
SKB264
Other name:
MK-2870
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
500 mg/m^2 via IV infusion
Arm group label:
Pemetrexed Plus Carboplatin
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC 5 mg/mL*min via IV infusion
Arm group label:
Pemetrexed Plus Carboplatin
Intervention type:
Drug
Intervention name:
Antihistamine
Description:
Administered as rescue medication per approved product label
Arm group label:
Sacituzumab tirumotecan
Intervention type:
Drug
Intervention name:
H2 Receptor Antagonist
Description:
Administered as rescue medication per approved product label
Arm group label:
Sacituzumab tirumotecan
Intervention type:
Drug
Intervention name:
Acetaminophen (or equivalent)
Description:
Administered as rescue medication per approved product label
Arm group label:
Sacituzumab tirumotecan
Intervention type:
Drug
Intervention name:
Dexamethasone (or equivalent)
Description:
Administered as rescue medication per approved product label
Arm group label:
Sacituzumab tirumotecan
Intervention type:
Drug
Intervention name:
Steroid Mouthwash (dexamethasone or equivalent)
Description:
Administered as rescue medication per approved product label
Arm group label:
Sacituzumab tirumotecan
Summary:
The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in
combination with carboplatin for the treatment of epidermal growth factor receptor
(EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in
this study have NSCLC that has continued to progress on prior treatment with EGFR
tyrosine kinase inhibitors (TKIs).
The primary hypotheses of this study are that sacituzumab tirumotecan is better than
platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to
progression-free survival (PFS) and overall survival (OS).
Detailed description:
Participants will be randomized 1:1 into two arms:
- Sacituzumab tirumotecan
- Pemetrexed plus Carboplatin
Participants will receive treatment until any of the criteria for discontinuation of
study intervention are met.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous
non-small cell lung cancer (NSCLC).
- Participants who have adverse events (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 Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks
and have undetectable HBV viral load.
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on antiretroviral therapy.
- Life expectancy of at least 3 months.
Exclusion Criteria:
- Predominantly squamous cell histology NSCLC.
- History of second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 3 years.
- Grade >2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or
blepharitis, or corneal disease that prevents/delays corneal healing.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous
history of inflammatory bowel disease.
- Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
- Received prior radiotherapy within 2 weeks of start of study intervention, or
radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines is allowed.
- Received radiation therapy to the lung that is >30 Gray within 6 months of the first
dose of study intervention.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Active infection requiring systemic therapy.
- History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease.
- Concurrent active HBV and HCV infection.
- History of allogeneic tissue/solid organ transplant.
- Participants who have not adequately recovered from major surgery or have ongoing
surgical complications.
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:
Astera Cancer Care ( Site 0032)
Address:
City:
East Brunswick
Zip:
08816
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
732-672-6405
Facility:
Name:
Millennium Research & Clinical Development ( Site 0035)
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
281-440-5006
Facility:
Name:
Instituto Alexander Fleming ( Site 0307)
Address:
City:
Ciudad Autónoma de Buenos Aires
Zip:
C1426ANZ
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5491166936669
Facility:
Name:
Hospital Británico de Buenos Aires-Oncology ( Site 0304)
Address:
City:
Ciudad autónoma de Buenos Aires
Zip:
C1280AEB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
1121571056
Facility:
Name:
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)
Address:
City:
Río Cuarto
Zip:
X5800ALB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
03512446211
Facility:
Name:
Instituto de Oncología de Rosario ( Site 0301)
Address:
City:
Rosario
Zip:
S2000KZE
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
54 9 341 5778394
Facility:
Name:
Clinica Adventista Belgrano-Oncology ( Site 0315)
Address:
City:
Caba
Zip:
1430
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5491132682903
Facility:
Name:
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303)
Address:
City:
La Rioja
Zip:
F5300COE
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+54 9 443 6443
Facility:
Name:
McGill University Health Centre ( Site 0204)
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5144411738
Facility:
Name:
Beijing Cancer hospital ( Site 3100)
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613521469355
Facility:
Name:
Chongqing University Cancer Hospital-Medical Oncology ( Site 3128)
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 13101235612
Facility:
Name:
Fujian Cancer Hospital ( Site 3124)
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13805086391
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 Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103)
Address:
City:
Nanning
Zip:
530200
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
13878106696
Facility:
Name:
The Second Affiliated Hospital of Nanchang University ( Site 3119)
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
8613767120022
Facility:
Name:
Jinan Central Hospital ( Site 3113)
Address:
City:
Jinan
Zip:
250013
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+86 18953116532
Facility:
Name:
Sichuan Cancer hospital ( Site 3127)
Address:
City:
Chengdu
Zip:
610042
Country:
China
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+8613880276636
Facility:
Name:
Nouvel Hôpital Civil (NHC) ( Site 1302)
Address:
City:
Strasbourg
Zip:
67091
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33369550905
Facility:
Name:
Hôpital Privé Clairval-CENTRE DE RADIOTHERAPIE ( Site 1306)
Address:
City:
Marseille
Zip:
13273
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0033496196230
Facility:
Name:
Gustave Roussy ( Site 1303)
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33142114211
Facility:
Name:
Hopitaux Universitaires Paris Centre-Hopital Cochin-Unité d'Oncologie Thoracique ( Site 1304)
Address:
City:
Paris
Zip:
75014
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33158413091
Facility:
Name:
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 1803)
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+390257489482
Facility:
Name:
National Hospital Organization Kyushu Cancer Center ( Site 3401)
Address:
City:
Fukuoka,
Zip:
811-1395
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-92-541-3231
Facility:
Name:
Kyushu University Hospital ( Site 3400)
Address:
City:
Fukuoka
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-92-641-1151
Facility:
Name:
Chungbuk National University Hospital ( Site 3804)
Address:
City:
Cheongju-si
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82432696015
Facility:
Name:
National Cancer Center ( Site 3803)
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 3807)
Address:
City:
Seongnam
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82317877071
Facility:
Name:
The Catholic University Of Korea St. Vincent's Hospital ( Site 3800)
Address:
City:
Suwon-si
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82312498153
Facility:
Name:
Ajou University Hospital ( Site 3813)
Address:
City:
Suwon
Zip:
16499
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82312195142
Facility:
Name:
Pusan National University Yangsan Hospital ( Site 3802)
Address:
City:
Busan
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:
Keimyung University Dongsan Hospital CRC room 1 ( Site 3814)
Address:
City:
Daegu
Zip:
42601
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82532586671
Facility:
Name:
Chungnam national university hospital ( Site 3806)
Address:
City:
Jung-gu
Zip:
35015
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82-42-280-8035
Facility:
Name:
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3812)
Address:
City:
Seoul
Zip:
03312
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82-2-2030-4360
Facility:
Name:
Asan Medical Center ( Site 3810)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82230103214
Facility:
Name:
Samsung Medical Center ( Site 3811)
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
82234103438
Facility:
Name:
Korea University Guro Hospital ( Site 3808)
Address:
City:
Seoul
Zip:
08308
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
821022179216
Facility:
Name:
University Malaya Medical Centre ( Site 3507)
Address:
City:
Lembah Pantai
Zip:
59100
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+6012-4553116
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:
Hospital Tengku Ampuan Afzan ( Site 3506)
Address:
City:
Kuantan
Zip:
25100
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6095706400
Facility:
Name:
Hospital Pulau Pinang-Oncology, radiotherapy and palliat ( Site 3501)
Address:
City:
George Town
Zip:
10450
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+60124931319
Facility:
Name:
Sarawak General Hospital-Radiotherapy Unit ( Site 3508)
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
6082276666
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48501446778
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:
Bialostockie Centrum Onkologii ( Site 2010)
Address:
City:
Bialystok
Zip:
15-027
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+48856784153
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:
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2322)
Address:
City:
Santiago de compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+34981950915
Facility:
Name:
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2323)
Address:
City:
Huelva
Zip:
21005
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34959016737
Facility:
Name:
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2324)
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
34955008932
Facility:
Name:
Karolinska Universitetssjukhuset Solna ( Site 2401)
Address:
City:
Stockholm
Zip:
171 64
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
46851770244
Start date:
June 11, 2024
Completion date:
June 14, 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/NCT06305754
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=2870-009&&kw=2870-009
