KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
Merck Sharp & Dohme LLC
Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Description
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC * Participants with nonsquamous NSCLC who are not eligible for an approved targeted therapy * Is able to provide archival tumor tissue sample collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initia…
Interventions
- BiologicalPembrolizumab
IV infusion
- DrugCarboplatin
IV infusion
- DrugPaclitaxel
IV infusion
- DrugPemetrexed
IV infusion
- BiologicalVibostolimab
IV infusion
- BiologicalBoserolimab
IV infusion
- BiologicalMK-4830
IV infusion
Locations (46)
- Banner MD Anderson Cancer Center ( Site 0001)Gilbert, Arizona
- City of Hope ( Site 0014)Duarte, California
- UCSF Medical Center at Mission Bay ( Site 0007)San Francisco, California
- Georgetown University ( Site 0036)Washington D.C., District of Columbia
- University of Kentucky Markey Cancer Center ( Site 0019)Lexington, Kentucky
- MedStar Franklin Square Medical Center ( Site 0033)Baltimore, Maryland