Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung
Conditions
Interventions
Intervention1: MK-1084 (100 mg): Dose: oral dose, qd, (MK-1084 dose is 100mg. The tablet strengths available are 25mg and 50mg).
Intervention2: Pembrolizumab (200 mg): Dose: intravenous (IV), weeks q3
Sponsors
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) ( MK-1084 plus pembrolizumab with placebo plus pembrolizumab ) Overall Survival (OS)Timepoint: From baseline to 07 years 0r PFS(whichever achieved first). | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response: CR or PRTimepoint: Baseline and Up to 72 Months;Duration of Response (DOR)Timepoint: Upto 72 Months;AE and Disscontinuation from the study due to an AE Timepoint: 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 30Timepoint: Baseline and Upto 72 Months;Change from baseline in physical functioning score, on the EORTC QLQ-C30, item 1-5 Timepoint: 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 Timepoint: Upto 72 Months | — |
Countries
Argentina, Australia, Austria, Brazil, Canada, Chile, China, Georgia, Germany, Greece, India, Italy, Japan, Mexico, Netherlands, New Zealand, Philippines, Poland, Republic of Korea, Romania, Spain, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed