Health Condition 1: C390- Malignant neoplasm of upper respiratory tract, part unspecified
Conditions
Interventions
Intervention1: 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.
Control Intervention1: Pe
Sponsors
Merck Sharp Dohme LLC a subsidiary of Merck and Co Inc
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Timepoint: The time from randomization to the first documented disease progression or death due to any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR)Timepoint: Up to approximately 51 months;Duration of Response (DOR)Timepoint: 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)Timepoint: Baseline and up to approximately 6 years;Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30Timepoint: 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)Timepoint: Baseline and up to approximately 6 years;Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13Timepoint: 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-C30Timepoint: Baseline and up to approximately 6 years;TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30Timepoint: Baseline and up to approximately 6 years;TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13Timepoint: Baseline and up to approximately 6 years;TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13Timepoint: Baseline and up to approximately 6 years;Number of Participants Who Experience One or More Adverse Events (AEs)Timepoint: up to approximately 6 years;Number of Participants Who Discontinue Study Treatment Due to an AETimepoint: up to approximately 6 years | — |
Countries
Argentina, Canada, China, Colombia, France, India, Italy, Japan, Malaysia, Mexico, Poland, Republic of Korea, Spain, Sweden, Taiwan, Thailand, Turkey, United States of America, Viet Nam
Contacts
Public ContactDr Monisha Sharma
MSD Pharmaceuticals Pvt Ltd
Outcome results
None listed