RecruitingCarcinoma, Non-Small-Cell Lung

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

Eligible age

18+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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).

Sponsor: Merck Sharp & Dohme LLC

You may qualify if…

✓ 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 Part B

You may not qualify if…

✕ The main exclusion criteria include but are not limited to the following:
✕ Has a diagnosis of small cell lung cancer
✕ Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
✕ Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
✕ Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
✕ Has an active autoimmune disease that has required systemic treatment in the past 2 years
✕ Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
✕ Has an active infection requiring systemic therapy