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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06345729
Registration number
NCT06345729
Ethics application status
Date submitted
28/03/2024
Date registered
3/04/2024
Date last updated
8/07/2025
Titles & IDs
Public title
A Study of MK-1084 Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) =50% (MK-1084-004)
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Scientific title
A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS =50%
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Secondary ID [1]
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MK-1084-004
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Secondary ID [2]
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1084-004
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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
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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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
Treatment: Drugs - MK-1084
Other interventions - Placebo
Treatment: Other - Pembrolizumab
Experimental: MK-1084 with Pembrolizumab - Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and MK-1084 by oral tablets once daily until discontinuation criterion is met.
Active comparator: Placebo with Pembrolizumab - Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.
Treatment: Drugs: MK-1084
Oral tablets
Other interventions: Placebo
Oral tablets
Treatment: Other: Pembrolizumab
IV infusion
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Intervention code [3]
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Treatment: Other
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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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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.
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Timepoint [1]
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Up to approximately 42 months
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [2]
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Up to approximately 56 months
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
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Timepoint [1]
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Up to approximately 42 months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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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 [2]
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Up to approximately 42 months
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Secondary outcome [3]
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Number of Participants Who Experience One or More Adverse Event (AEs)
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Assessment method [3]
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An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.
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Timepoint [3]
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Up to approximately 56 months
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Secondary outcome [4]
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Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
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Assessment method [4]
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An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.
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Timepoint [4]
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Up to approximately 56 months
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Secondary outcome [5]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
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Assessment method [5]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. Higher scores indicate a better overall health status.
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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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
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Assessment method [6]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. Higher scores indicate a better level of functioning.
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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 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score
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Assessment method [7]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. Higher scores indicate a better level of functioning.
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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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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score
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Assessment method [8]
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The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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). The change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. A higher score indicates a worse level of dyspnea.
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Timepoint [8]
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Baseline and Up to approximately 24 months
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Secondary outcome [9]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score
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Assessment method [9]
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The EORTC QLQ-C13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. A higher score indicates more frequent coughing.
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Timepoint [9]
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Baseline and Up to approximately 24 months
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Secondary outcome [10]
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Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score
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Assessment method [10]
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The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. 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). The change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. A higher score indicates a worse level of chest pain.
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Timepoint [10]
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Baseline and Up to approximately 24 months
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Secondary outcome [11]
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Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
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Assessment method [11]
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TTD is defined as the time from baseline to the first onset of a =10-point negative change (decrease) from baseline in global health status (GHS) and quality of life (QoL) (EORTC QLQ-C30 Items 29 and 30) score. Participant responses to the questions "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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10 point negative change (decrease) from baseline in GHS and QoL, will be presented. A longer TTD indicates a better outcome.
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Timepoint [11]
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Baseline and Up to approximately 24 months
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Secondary outcome [12]
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Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score
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Assessment method [12]
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TTD is defined as the time from baseline to the first onset of a =10-point negative change (decrease) from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning 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 TTD, as assessed based on a =10 point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.
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Timepoint [12]
0
0
Baseline and Up to approximately 24 months
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Secondary outcome [13]
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Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score
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Assessment method [13]
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TTD is defined as the time from baseline to the first onset of a =10-point negative change (decrease) from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning 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 TTD, as assessed based on a =10 point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.
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Timepoint [13]
0
0
Baseline and Up to approximately 24 months
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Secondary outcome [14]
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Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score
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Assessment method [14]
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TTD is defined as the time from baseline to the first onset of a =10-point negative change (decrease) from baseline in dyspnea (EORTC QLQ-C30 Item 8) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10 point negative change (decrease) from baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.
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Timepoint [14]
0
0
Baseline and Up to approximately 24 months
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Secondary outcome [15]
0
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Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score
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Assessment method [15]
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TTD is defined as the time from baseline to the first onset of a =10-point negative change (decrease) from baseline in cough (EORTC QLQ-C13 Item 31) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question "Have you coughed?" is 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 TTD, as assessed based on a =10 point negative change (decrease) from baseline in cough score, will be presented. A longer TTD indicates a better outcome.
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Timepoint [15]
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0
Baseline and Up to approximately 24 months
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Secondary outcome [16]
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Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score
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Assessment method [16]
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TTD is defined as the time from baseline to the first onset of a =10-point negative change (decrease) from baseline in chest pain (EORTC QLQ-C13 Item 40) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a =10 point negative change (decrease) from baseline chest pain score, will be presented. A longer TTD indicates a better outcome.
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Timepoint [16]
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Baseline and Up to approximately 24 months
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Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:
* Has a histologically or cytologically confirmed diagnosis of NSCLC
* Has newly diagnosed Stage IV NSCLC by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8
* Has measurable disease based on RECIST 1.1
* Has provided tumor tissue that demonstrates PD-L1 expression in =50% of tumor cells
* Has provided tumor tissue that demonstrates presence of KRAS G12C mutation
* Has life expectancy of at least 3 months
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
* For participant assigned male sex at birth: If capable of producing sperm, participant must agree to the following during the study treatment period and for at least 10 days after the last dose of oral intervention: Either be abstinent or must agree to use male condom plus additional contraceptive method.
* For participant assigned female sex at birth: Either be a person of nonchildbearing potential (PONCBP) or must agree to follow contraceptive guidance during the study treatment period and for at least 10 days after the last dose of oral intervention and 120 days after the last dose of pembrolizumab. Must abstain from breastfeeding during the study intervention period and for at least 120 days after study intervention.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
* 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 before randomization
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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
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
* Has a known history of, or active, neurologic paraneoplastic syndrome
* Has an active infection requiring systemic therapy
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention
* Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
* Has one or more of the following ophthalmological findings/conditions: intraocular diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease pressure >21 mm Hg and/or any diagnosis of glaucoma
* Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, or malabsorption)
* Received prior systemic anticancer therapy for their metastatic NSCLC
* Received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor within 12 months before diagnosis of metastatic NSCLC
* Has received radiotherapy within 2 weeks of start of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Active autoimmune disease that has required systemic treatment in the past 2 years
* 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
* History of allogeneic tissue/solid organ transplant
* Has not fully recovered from any effects of major surgical procedure. Surgical procedures that required general anesthesia must be completed at least 2 weeks before first study intervention administration.
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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 receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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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
24/05/2024
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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
18/02/2031
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse ( Site 3000) - Camperdown
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Recruitment hospital [2]
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Frankston Hospital ( Site 3002) - Frankston
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Recruitment hospital [3]
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One Clinical Research ( Site 3001) - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Florida
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Illinois
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Missouri
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Montana
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New Jersey
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New York
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Ohio
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Texas
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Austria
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Steiermark
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Austria
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Wien
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Brazil
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Minas Gerais
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Brazil
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Pernambuco
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Brazil
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Piaui
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Brazil
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Rio Grande Do Norte
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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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Brazil
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Rio de Janeiro
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Bulgaria
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Pazardzhik
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Bulgaria
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Pleven
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Quebec
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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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Anhui
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China
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Beijing
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Fujian
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China
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Guangdong
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China
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Heilongjiang
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China
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Henan
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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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Jilin
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China
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Shaanxi
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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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Shanxi
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China
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Sichuan
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China
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Xinjiang
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China
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Yunnan
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China
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Zhejiang
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France
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Bourgogne
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France
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Ile-de-France
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France
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Nord
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France
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Puy-de-Dome
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France
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Vaucluse
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Georgia
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Ajaria
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Georgia
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Tbilisi
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Germany
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Baden-Wurttemberg
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Germany
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Nordrhein-Westfalen
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Greece
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Achaia
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Greece
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Attiki
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Greece
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Kentriki Makedonia
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Greece
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Thessalia
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Greece
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Thessaloniki
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Italy
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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Roma
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Italy
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Toscana
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Mie
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Chiba
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Japan
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Hiroshima
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Japan
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Kumamoto
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Korea, Republic of
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Incheon
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Jeonranamdo
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Kyonggi-do
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Korea, Republic of
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Kyongsangnam-do
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Korea, Republic of
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Taejon-Kwangyokshi
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Oaxaca
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Netherlands
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Overijssel
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Utrecht
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Malopolskie
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Mazowieckie
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Romania
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Dolj
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Romania
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Timis
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Romania
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Brasov
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Romania
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Cluj
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Romania
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Suceava
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Las Palmas
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Madrid, Comunidad De
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Madrid
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Sevilla
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Turkey
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Adana
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Turkey
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Ankara
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Istanbul
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Ukraine
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Cherkaska Oblast
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Ukraine
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Chernivetska Oblast
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Ukraine
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Dnipropetrovska Oblast
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Ukraine
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Ivano-Frankivska Oblast
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Ukraine
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Kirovohradska Oblast
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Ukraine
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Kyivska Oblast
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Ukraine
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Lvivska Oblast
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Ukraine
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Ukraine
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Vinnytska Oblast
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Ukraine
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Volynska Oblast
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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
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Summary
Brief summary
This is a study evaluating the efficacy and safety of MK-1084 with pembrolizumab as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) =50%. There are two primary study hypotheses: Hypothesis 1: Combination of MK-1084 and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). Hypothesis 2: Combination of MK-1084 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).
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Trial website
https://clinicaltrials.gov/study/NCT06345729
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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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Contact person for public queries
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Toll Free Number
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Phone
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0
1-888-577-8839
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Email
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0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06345729
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