| CTRI Number |
CTRI/2024/12/078693 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Phase 3 study of MK-2870 Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) |
|
Scientific Title of Study
|
A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors |
| Trial Acronym |
MK2870-009 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MK2870-009 Version 00 Dated 24 Jan 2024 |
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
Gurgaon
HARYANA
122002
India |
| Phone |
|
| 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 Sector 54
Gurgaon
HARYANA
122002
India
Gurgaon
HARYANA
122002
India |
| Phone |
1244647300 |
| 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 Sector 54
Gurgaon
HARYANA
122002
India
Gurgaon
HARYANA
122002
India |
| Phone |
1244647300 |
| Fax |
|
| Email |
monisha_sharma@merck.com |
|
|
Source of Monetary or Material Support
|
| Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc 126 East Lincoln Ave. P.O. Box 2000
Rahway, NJ 07065 USA |
|
|
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 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Argentina
Canada
China
Colombia
France
India
Italy
Japan
Malaysia
Mexico
Poland
Spain
Sweden
Taiwan
Thailand
Turkey
United States of America
Viet Nam
Republic of Korea |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sachin Khurana |
AIIMS, New Delhi |
Room No.160D, I st Floor, Dr. B.R. Arnbedkar Institute of Rotary Cancer Hospital, All India Institute of Medical Sciences, Department of Medical Oncology, Ansari Nagar, New Delhi- 110029, India
New Delhi
DELHI |
919769030180
dr.sachinkhurana@gmail.com |
| Dr Hari Goyal |
Artemis Hospitals |
Artemis Hospitals, Sector 51, Gurgaon, Haryana-122001, India
Gurgaon
HARYANA |
9958715678
harigoyal@artemishospitals.com |
| Dr PK Das |
Indraprastha Apollo Hospitals |
Indraprastha Apollo Hospitals, Sarita Vihar, Mathura Road, New Delhi- 110076, India
New Delhi
DELHI |
919810444600
drpratapdas@gmail.com |
| Dr Sandeep Goyle |
Kokilaben Dhirubhai Ambani Hospital |
Kokilaben Dhirubhai Ambani Hospital &
Medical Research Institute, 2nd Floor, Centre for Cancer, Rao Saheb Achutrao Patwardhan Marg, Four Bungalows, Andheri - West, Mumbai -
400053 Maharashtra, India.
Mumbai
MAHARASHTRA |
9322527910
sandeep.goyle@kokilabenhospitals.com |
| Dr Ullas Batra |
Rajiv Gandhi Cancer Institute And Research Centre |
Room No 3153,Department Of Medical Oncology, Rajiv Gandhi, Cancer Institute and Research Centre, Sector 5, Rohini, New Delhi -110085
New Delhi
DELHI |
911147022264
ubclinicaltrial@gmail.com |
| Dr Kumar Prabhash |
Tata Memorial Centre |
Room No. 1109, 11 th Floor, Homi Bhabha Block, Tata Memorial Hospital, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel (E), Mumbai - 400012, Maharashtra, India
Mumbai
MAHARASHTRA |
91-9167760576
kprabhash1@gmail.com |
| Dr Kaushal Kalra |
VMMC and Safdarjung Hospital |
VMMC and Safdarjung Hospital Medical Oncology Block Old SIC Building New Delhi 110029
New Delhi
DELHI |
91-9968663394
kaushalkalra@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Kokilaben Dhirubhai Ambani Hospital Rao saheb Achutrao Patwardhan Marg, Four Bunglows Andheri West Mumbai, Mumbai City Maharashtra - 400053 |
Approved |
| Artemis Health Sciences Institutional Ethics Committee 2nd Floor, B-Wing (ICU), Artemis Hospital, Sector 51, Gurugram, Haryana- 122001 |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences, Old OT Block, Room No. 102, AIIMS Hospital, Ansari Nagar, New-Delhi, Delhi-110029 |
Approved |
| Institutional Ethics Committee Indraprastha Apollo Hospital, Sarita Vihar Delhi-Mathura Road, New Delhi-110076, India |
Approved |
| Institutional Ethics Committee VMMC and Safdarjung Hospital New Delhi 110029 |
Approved |
| Institutional Ethics Committee, 3rd Floor, Main Building, Parel, Mumbai-400012, Maharashtra, India |
Approved |
| Institutional Review Board Rajiv Gandhi Cancer Institute and Research Centre Rohini Sector V Rohini west Metro station Delhi South West Delhi Delhi - 110085 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C390||Malignant neoplasm of upper respiratory tract, part unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Carboplatin 5 mg/mL |
Dose : Adults Carboplatin AUC 5 mg/mL min via intravenous IV infusion Days 1 and 22 of every 6-week cycle for 4 doses |
| Intervention |
MK2870 |
Dose: MK-2870 200 mg/vial via intravenous (IV) infusion every 2 weeks (Days 1, 15, and 29 of every 6-week cycle) until discontinuation criteria is met. |
| Comparator Agent |
Pemetrexed 500 mg/m2 |
Dose: Adults: Pemetrexed 500 mg/m2 via intravenous (IV) infusion Days 1 and 22 of every 6-week cycle |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Is an individual of any sex gender of at least 18 years of age at the time of providing the informed consent.
Have histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous NSCLC. Advanced stage is defined as Stage IV or Stage III not eligible for curative resection or curative chemoradiation AJCC Version 8 or current version as applicable
Have documentation of tumor activating EGFR mutation, exon 19del, L858R, G719X,S768I, or L861Q.
Have provided tissue sample core, incisional, or excisional biopsy of a tumor lesion not previously irradiated as soon as possible. FFPE tissue blocks are preferred to slides.
Tissue is required for determination of TROP2 status by central vendor before randomization.
Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer NSCLC
Measurable disease per RECIST 1.1 as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
Participants who have adverse events AEs due to previous anticancer therapies must have recovered to Grade 1 or baseline.
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.
Participants with history of Hepatitis C virus HCV infection are eligible if HCV viral load is undetectable
Human immunodeficiency virus HIV infected participants must have well controlled HIV on antiretroviral therapy.
Life expectancy of at least 3 months.
|
|
| ExclusionCriteria |
| Details |
Predominantly squamous cell histology NSCLC.
History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
Grade more than 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.
Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
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 is allowed.
Received radiation therapy to the lung that is 30 Gray within 6 months of the first dose of study intervention
Known active central nervous system metastases and or carcinomatous meningitis.
Active infection requiring systemic therapy.
History of noninfectious pneumonitis interstitial lung disease that required steroids or has current pneumonitis interstitial lung disease
HIV infected participants with a history of Kaposis sarcoma and or Multicentric Castlemans Disease.
Concurrent active HBV and HCV infection
History of allogeneic tissue solid organ transplant.
Participants who have not adequately recovered from major surgery or have ongoing surgical complications
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare MK-2870 to platinum-based
doublet chemotherapy with respect to PFS
per RECIST 1.1 as assessed by BICR
Hypothesis (H1): MK-2870 is superior to
platinum-based doublet chemotherapy with
respect to PFS per RECIST 1.1 as assessed
by BICR
|
The time from randomization to the
first documented disease progression or
death due to any cause, whichever occurs
first |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective Response Rate (ORR) |
Up to approximately 51 months |
| Duration of Response (DOR) |
Up to approximately 51 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 (EORTC QLQ-C30) |
Baseline and up to approximately 6 years |
| Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 |
Baseline and up to approximately 6 years |
| Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13) |
Baseline and up to approximately 6 years |
| Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 |
Baseline and up to approximately 6 years |
| Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30 |
Baseline and up to approximately 6 years |
| TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30 |
Baseline and up to approximately 6 years |
| TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13 |
Baseline and up to approximately 6 years |
| TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13 |
Baseline and up to approximately 6 years |
| Number of Participants Who Experience One or More Adverse Events (AEs) |
up to approximately 6 years |
| Number of Participants Who Discontinue Study Treatment Due to an AE |
up to approximately 6 years |
|
|
Target Sample Size
|
Total Sample Size="520"
Sample Size from India="40"
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)
Modification(s)
|
23/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
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
|
NSCLC remains a public health problem and the leading cause of cancer mortality worldwide. EGFR mutations are commonly found in NSCLC, and patients with these mutations eventually progress on current 1L treatment regimens using TKIs. New therapeutic options need to be investigated for this population to improve both PFS and OS, especially in patients who have progressed after current SOC practice. |