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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06170788




Registration number
NCT06170788
Ethics application status
Date submitted
3/12/2023
Date registered
14/12/2023
Date last updated
18/10/2024

Titles & IDs
Public title
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) = 50% (MK-2870-007)
Scientific title
A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50%
Secondary ID [1] 0 0
MK-2870-007
Secondary ID [2] 0 0
2870-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Sacituzumab tirumotecan
Treatment: Other - Pembrolizumab

Experimental: Pembrolizumab + Sacituzumab tirumotecan - Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.

Active comparator: Pembrolizumab - Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles


Treatment: Other: Sacituzumab tirumotecan
IV infusion

Treatment: Other: Pembrolizumab
IV infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to approximately 48 months
Secondary outcome [1] 0 0
Progression free survival (PFS)
Timepoint [1] 0 0
Up to approximately 48 months
Secondary outcome [2] 0 0
Objective Response (OR)
Timepoint [2] 0 0
Up to approximately 48 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to approximately 48 months
Secondary outcome [4] 0 0
Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score
Timepoint [4] 0 0
Baseline and up to approximately 24 months
Secondary outcome [5] 0 0
Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
Timepoint [5] 0 0
Baseline and up to approximately 24 months
Secondary outcome [6] 0 0
Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score
Timepoint [6] 0 0
Baseline and up to approximately 24 months
Secondary outcome [7] 0 0
Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score
Timepoint [7] 0 0
Baseline and up to approximately 24 months
Secondary outcome [8] 0 0
Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30)
Timepoint [8] 0 0
Up to approximately 24 months
Secondary outcome [9] 0 0
Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
Timepoint [9] 0 0
Up to approximately 24 months
Secondary outcome [10] 0 0
Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31).
Timepoint [10] 0 0
Up to approximately 24 months
Secondary outcome [11] 0 0
Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)
Timepoint [11] 0 0
Up to approximately 24 months
Secondary outcome [12] 0 0
Percentage of Participants That Experience at Least 1 Adverse Event
Timepoint [12] 0 0
Up to approximately 27 months
Secondary outcome [13] 0 0
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Timepoint [13] 0 0
Up to approximately 24 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC

* Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
* Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in =50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
* A life expectancy of at least 3 months.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Has 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.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
* 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 are allowed.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (=Grade 3) is exclusionary.
* Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
* Active infection requiring systemic therapy
* Concurrent active Hepatitis B and Hepatitis C virus infection.
* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* History of allogeneic tissue/solid organ transplant.
* Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/05/2030
Actual
Sample size
Target
614
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002) - Port Macquarie
Recruitment hospital [2] 0 0
Westmead Hospital-Department of Medical Oncology ( Site 3000) - Westmead
Recruitment hospital [3] 0 0
Grampians Health-Medical Oncology ( Site 3001) - Ballarat Central
Recruitment hospital [4] 0 0
Northern Hospital ( Site 3003) - Epping
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3350 - Ballarat Central
Recruitment postcode(s) [4] 0 0
3076 - Epping
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
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United States of America
State/province [4] 0 0
Maine
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United States of America
State/province [5] 0 0
Massachusetts
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United States of America
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Minnesota
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United States of America
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Mississippi
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United States of America
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Nevada
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Ohio
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Oregon
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Texas
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Cordoba
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Argentina
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Santa Fe
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Rio de Janeiro
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Canada
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Ontario
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Canada
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Quebec
Country [21] 0 0
Chile
State/province [21] 0 0
Maule
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Chile
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Region M. De Santiago
Country [23] 0 0
China
State/province [23] 0 0
Anhui
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China
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Beijing
Country [25] 0 0
China
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Fujian
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China
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Guangdong
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China
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Hebei
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jiangxi
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China
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Shandong
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China
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Shanghai
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China
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Sichuan
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China
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Yunnan
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China
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Zhejiang
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Colombia
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Cordoba
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Distrito Capital De Bogota
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Bayern
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Thuringen
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Friuli-Venezia Giulia
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Puglia
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Italy
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Taegu-Kwangyokshi
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Korea, Republic of
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Seoul
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Netherlands
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Noord-Brabant
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Netherlands
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Overijssel
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Ariqipa
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Muni Metro De Lima
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Lima
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Kujawsko-pomorskie
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Malopolskie
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Mazowieckie
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Podkarpackie
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Portugal
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Lisboa
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Cadiz
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La Coruna
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Madrid
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Spain
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Malaga
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Spain
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Valenciana, Comunitat
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Spain
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Barcelona
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Spain
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Sevilla
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Thailand
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Krung Thep Maha Nakhon
Country [86] 0 0
Thailand
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Chiang Mai
Country [87] 0 0
Turkey
State/province [87] 0 0
Istanbul
Country [88] 0 0
Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Denizli
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Turkey
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Samsun
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United Kingdom
State/province [94] 0 0
Hampshire
Country [95] 0 0
United Kingdom
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Kent
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London, City Of
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.

All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.
Trial website
https://clinicaltrials.gov/study/NCT06170788
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06170788