| CTRI Number |
CTRI/2025/05/087296 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
MK-1084 with pembrolizumab and pembrolizumab with placebo in newly diagnosed Stage IV NSCLC with KRAS G12Cmutation and PD-L1 TPS50 |
|
Scientific Title of Study
|
MK1084-004-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 more than or equal to 50%. |
| Trial Acronym |
MK1084-004 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MK1084 Version 004-00 Dated 15 Dec 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Monisha Sharma |
| Designation |
Senior Director- Clinical Research |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd |
| Address |
MSD Pharmaceuticals Pvt Ltd, 6th Floor, Tower B, Vatika Towers, Sector 54
Gurgaon
HARYANA
122002
India |
| Phone |
911244647300 |
| Fax |
|
| Email |
monisha_sharma@merck.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monisha Sharma |
| Designation |
Senior Director- Clinical Research |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd |
| Address |
MSD Pharmaceuticals Pvt Ltd, 6th Floor, Tower B, Vatika Towers, Sector 54
HARYANA
122002
India |
| Phone |
911244647300 |
| Fax |
|
| Email |
monisha_sharma@merck.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monisha Sharma |
| Designation |
Senior Director- Clinical Research |
| Affiliation |
MSD Pharmaceuticals Pvt Ltd |
| Address |
MSD Pharmaceuticals Pvt Ltd, 6th Floor, Tower B, Vatika Towers, Sector 54
HARYANA
122002
India |
| Phone |
911244647300 |
| Fax |
|
| Email |
monisha_sharma@merck.com |
|
|
Source of Monetary or Material Support
|
| “M/s MSD Pharmaceuticals Private Limited, 6th Floor, Tower-B, Vatika Tower, Sector 54, Haryana (India) – 122001.” |
|
|
Primary Sponsor
|
| Name |
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc |
| Address |
126 East Lincoln Ave. P.O. Box 2000 Rahway, NJ 07065 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
China
India
Japan
Australia
Argentina
Austria
Brazil
Canada
Chile
Georgia
Germany
Greece
Italy
Mexico
Netherlands
New Zealand
Philippines
Poland
Republic of Korea
Romania
Spain
Turkey
Ukraine
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankit Jain |
Indraprastha Apollo Hospital |
Indraprastha Apollo Hospital,
Sarita Vihar
Delhi-Mathura Road, New Delhi-110076, India
South
DELHI |
7859065070
drankit_j@apollohospitals.com |
| Dr Bhuvan Chugh |
Max Super Speciality Hospital |
Max Super Speciality Hospital, Saket East Block (A Unit of Devki Devi Foundation) 2, Press Enclave Road, Saket, New Delhi-110017
South
DELHI |
011-26515050
Bhuvan.Chugh@maxhealthcare.com |
| Dr Sewanti Limaye |
SIR H. N. Reliance Foundation Hospital and Research Centre |
SIR H. N. Reliance Foundation Hospital and Research Centre Raja Rammohan Roy Road, Prarthana Samaj, Mumbai, Maharashtra 400004
Mumbai
MAHARASHTRA |
9619607339
Sewanti.Limaye@rfhospital.org |
| Dr Nandini Menon |
Tata Memorial Centre, Tata Memorial Hospital |
Room No. I I 09, I I th Floor, Homi Bhabha Block, Tata Memorial Hospital, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel (E), Mumbai - 400012, Maharashtra, India
Mumbai
MAHARASHTRA |
022-24177000
nandini.menon1412@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Tata Memorial Hospital, Parel |
Submittted/Under Review |
| Institutional Ethics Committee of Sir H N Reliance Foundation Hospital and Research Centre |
Approved |
| Institutional Ethics Committee, Devki Devi Foundation |
Approved |
| Intuitional Ethics Committee-Clinical Studies Indraprastha Apollo Hospitals, Sarita Vihar, Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MK-1084 (100 mg) |
Dose: oral dose, qd, (MK-1084 dose is 100mg. The tablet strengths available are 25mg and 50mg). |
| Intervention |
Pembrolizumab (200 mg) |
Dose: intravenous (IV), weeks q3w for up to 35 Administration |
| Comparator Agent |
Placebo |
Dose: oral dose, qd |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Demographics
Is an individual of any sex gender, from at least 18 years of age at the time of providing
the informed consent.
Has a histologically or cytologically confirmed diagnosis of NSCLC.
Has newly diagnosed Stage IV (M1a, M1b, or M1c) by AJCC Staging Manual, Version 8
Has provided tumor tissue that demonstrates PD-L1 expression in more than or equal to 50 percent of tumor cells(TPS more than or equal to 50 percent) as assessed by IHC 22C3 at a central laboratory.
Has life expectancy of at least 3 months.
Has ECOG performance status of 0 or 1 assessed within 7 days before randomization.
Has adequate organ function
Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
|
|
| ExclusionCriteria |
| Details |
An individual must be excluded from the study if the individual meets any of the following
criteria
Diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present
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 an active infection requiring systemic therapy.
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease
Received prior systemic anticancer therapy for their metastatic NSCLC
Has received previous treatment with an agent targeting KRAS mutations
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
Has experienced an early recurrence (less than 6 months after completing adjuvant or neoadjuvant chemotherapy) and therefore is eligible to receive second line (2L) treatment
Has known active CNS metastases and or carcinomatous meningitis
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
History or current evidence of any condition, therapy, laboratory abnormality
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Progression-Free Survival (PFS) ( MK-1084 plus pembrolizumab with placebo plus pembrolizumab )
Overall Survival (OS) |
From baseline to 07 years 0r PFS(whichever achieved first). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective response: CR or PR |
Baseline and Up to 72 Months |
| Duration of Response (DOR) |
Upto 72 Months |
AE and Disscontinuation from the study due to
an AE
|
Upto 72 Months |
| Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 item 29 and 30 |
Baseline and Upto 72 Months |
Change from baseline in physical functioning score, on the EORTC QLQ-C30, item 1-5
|
Baseline and Upto 72 Months |
Role functioning score, on the EORTC QLQ-C30, item 6-7
Dyspnea score, on the EORTC QLQ-C30, item 8
Cough on the EORTC QLQ-LC 13 item 31
Chest pain on the EORTC QLQ- LC 13 item 40
Time to first Deterioration (TTD) in global health status/quality of life scores, on the EORTC item 29 and 30
TTD in physical functioning score, on the EORTC QLQ-C30 item 1-5
TTD in Role functioning score, on the EORTC QLQ-C30, item 6-7
TTD in Dyspnea score, on the EORTC QLQ-C30, item 8
TTD in Cough on the EORTC QLQ-LC 13 item 31
TTD in Chest pain on the EORTC QLQ- LC 13 item 40
|
Upto 72 Months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="9"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="7"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
|