KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Wi
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 o
| Condition(s) | Carcinoma, Non-Small-Cell Lung |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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). |
| Who can participate | 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 initiation * Has not received prior systemic treatment for their metastatic NSCLC * Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for P |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Locations | Gilbert, Arizona, United States; Duarte, California, United States; San Francisco, California, United States; Washington D.C., District of Columbia, United States; Lexington, Kentucky, United States; Baltimore, Maryland, United States (+40 more sites) |
| Start date | 2019-12-19 |
| NCT ID | NCT04165070 |
| Official listing | https://clinicaltrials.gov/study/NCT04165070 |