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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

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)
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%
Secondary ID [1] 0 0
MK-1084-004
Secondary ID [2] 0 0
1084-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 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: 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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 42 months
Primary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Up to approximately 56 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 42 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 42 months
Secondary outcome [3] 0 0
Number of Participants Who Experience One or More Adverse Event (AEs)
Timepoint [3] 0 0
Up to approximately 56 months
Secondary outcome [4] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [4] 0 0
Up to approximately 56 months
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
Baseline and Up to approximately 24 months
Secondary outcome [16] 0 0
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
Timepoint [16] 0 0
Baseline and Up to approximately 24 months

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
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
* 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.

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 receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
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
24/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/02/2031
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Montana
Country [2] 0 0
United States of America
State/province [2] 0 0
Ohio
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Brazil
State/province [4] 0 0
Piaui
Country [5] 0 0
Brazil
State/province [5] 0 0
Rio Grande Do Norte
Country [6] 0 0
Chile
State/province [6] 0 0
Maule
Country [7] 0 0
Chile
State/province [7] 0 0
Region M. De Santiago
Country [8] 0 0
Japan
State/province [8] 0 0
Mie
Country [9] 0 0
Japan
State/province [9] 0 0
Tokyo
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Incheon
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Jeonranamdo
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Kyonggi-do
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Kyongsangnam-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland
Country [16] 0 0
Ukraine
State/province [16] 0 0
Cherkaska Oblast
Country [17] 0 0
Ukraine
State/province [17] 0 0
Chernivetska Oblast
Country [18] 0 0
Ukraine
State/province [18] 0 0
Dnipropetrovska Oblast
Country [19] 0 0
Ukraine
State/province [19] 0 0
Ivano-Frankivska Oblast
Country [20] 0 0
Ukraine
State/province [20] 0 0
Kirovohradska Oblast
Country [21] 0 0
Ukraine
State/province [21] 0 0
Kyivska Oblast
Country [22] 0 0
Ukraine
State/province [22] 0 0
Lvivska Oblast
Country [23] 0 0
Ukraine
State/province [23] 0 0
Rivnenska Oblast
Country [24] 0 0
Ukraine
State/province [24] 0 0
Vinnytska Oblast
Country [25] 0 0
Ukraine
State/province [25] 0 0
Volynska Oblast

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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