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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06170788
Registration number
NCT06170788
Ethics application status
Date submitted
3/12/2023
Date registered
14/12/2023
Date last updated
10/06/2024
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)
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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%
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Secondary ID [1]
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MK-2870-007
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Secondary ID [2]
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2870-007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC)
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
0
0
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0
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Lung - Non small cell
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Cancer
0
0
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0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Sacituzumab tirumotecan
Other interventions - 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
Other interventions: Sacituzumab tirumotecan
IV infusion
Other interventions: Pembrolizumab
IV infusion
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to death from any cause.
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Timepoint [1]
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Up to approximately 48 months
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Secondary outcome [1]
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Progression free survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first
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Timepoint [1]
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Up to approximately 48 months
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Secondary outcome [2]
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Objective Response (OR)
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Assessment method [2]
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The OR is defined as a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.
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Timepoint [2]
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Up to approximately 48 months
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
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Timepoint [3]
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Up to approximately 48 months
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Secondary outcome [4]
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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
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Assessment method [4]
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Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.
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Timepoint [4]
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Baseline and up to approximately 24 months
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Secondary outcome [5]
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Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score
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Assessment method [5]
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Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.
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Timepoint [5]
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Baseline and up to approximately 24 months
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Secondary outcome [6]
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Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score
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Assessment method [6]
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Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.
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Timepoint [6]
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Baseline and up to approximately 24 months
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Secondary outcome [7]
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Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score
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Assessment method [7]
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The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.
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Timepoint [7]
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Baseline and up to approximately 24 months
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Secondary outcome [8]
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Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30)
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Assessment method [8]
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The TTD in GHS/QOL score (EORTC QLQ-C30 Items 29 and 30) will be presented. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD as assessed based on a negative change (decrease in score) from Baseline in GHS/QOL score. A longer TTD indicates a better outcome.
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Timepoint [8]
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Up to approximately 24 months
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Secondary outcome [9]
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Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8)
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Assessment method [9]
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The TTD in Dyspnea score (EORTC QLQ-C30 Item 8) will be presented. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
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Timepoint [9]
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Up to approximately 24 months
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Secondary outcome [10]
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Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31).
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Assessment method [10]
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The TTD in Cough score (EORTC QLQ-LC13 Item 31) will be presented. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
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Timepoint [10]
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Up to approximately 24 months
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Secondary outcome [11]
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Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40)
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Assessment method [11]
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The TTD in Chest Pain score (EORTC QLQ-LC13 Item 40) will be presented. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.
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Timepoint [11]
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Up to approximately 24 months
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Secondary outcome [12]
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Percentage of Participants That Experience at Least 1 Adverse Event
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Assessment method [12]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be presented.
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Timepoint [12]
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Up to approximately 27 months
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Secondary outcome [13]
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Percentage of Participants Who Discontinue Study Treatment Due to an AE
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Assessment method [13]
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The percentage of participants who discontinue study treatment due to an AE will be presented.
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Timepoint [13]
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Up to approximately 24 months
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/05/2030
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Actual
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Sample size
Target
614
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002) - Port Macquarie
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Recruitment hospital [2]
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Westmead Hospital-Department of Medical Oncology ( Site 3000) - Westmead
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Recruitment hospital [3]
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Grampians Health-Medical Oncology ( Site 3001) - Ballarat Central
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Recruitment hospital [4]
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Northern Hospital ( Site 3003) - Epping
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Recruitment postcode(s) [1]
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2444 - Port Macquarie
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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3350 - Ballarat Central
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Recruitment postcode(s) [4]
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3076 - Epping
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Georgia
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United States of America
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Kentucky
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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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Nevada
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United States of America
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Oregon
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United States of America
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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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Chile
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Maule
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Chile
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Region M. De Santiago
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China
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Beijing
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China
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Guangdong
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China
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Jiangsu
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China
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Sichuan
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China
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Zhejiang
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Denmark
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Midtjylland
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Nordjylland
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France
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Bouches-du-Rhone
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France
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Herault
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France
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Limousin
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France
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Meurthe-et-Moselle
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France
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Pyrenees-Atlantiques
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France
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Rhone
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France
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Somme
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Italy
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Roma
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Korea, Republic of
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Chungbuk
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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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Spain
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Cadiz
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Spain
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Madrid
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Spain
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Barcelona
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Taiwan
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Kaohsiung
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Tainan
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Taiwan
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Taipei
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Taiwan
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Hsinchu
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Taichung
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Thailand
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Chiang Mai
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Turkey
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Istanbul
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Turkey
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Kayseri
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Turkey
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Adana
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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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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06170788
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
0
0
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Phone
0
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06170788
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