KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)

Official Summary

This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 1,065 participants

Interventions

• DIAGNOSTIC_TEST: Tumor Imaging — Participants will undergo tumor imaging using either a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan.
• PROCEDURE: Tumor Tissue Collection — Participants without archival tumor tissue samples will undergo tumor tissue collection for newly obtained tumor tissue.
• PROCEDURE: Blood Sample Collection — Participants will have blood samples drawn for analysis of: * genetics * ribonucleic acid (RNA) * serum biomarker * plasma biomarker * circulating tumor DNA (ctDNA)

Primary Outcomes

• Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% (Up to approximately 1 month)
• Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC (Up to approximately 1 month)

Eligibility Criteria

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
* Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy

Trial Locations

• Banner MD Anderson Cancer Center ( Site 0001), Gilbert, Arizona, United States
• City of Hope ( Site 0014), Duarte, California, United States
• UCSF Medical Center at Mission Bay ( Site 0007), San Francisco, California, United States
• Georgetown University ( Site 0036), Washington D.C., District of Columbia, United States
• University of Kentucky Markey Cancer Center ( Site 0019), Lexington, Kentucky, United States
• MedStar Franklin Square Medical Center ( Site 0033), Baltimore, Maryland, United States
• Massachusetts General Hospital ( Site 0003), Boston, Massachusetts, United States
• Dana Farber Cancer Institute ( Site 0002), Boston, Massachusetts, United States
• Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031), Omaha, Nebraska, United States
• Dartmouth Hitchcock Medical Center ( Site 0016), Lebanon, New Hampshire, United States
• ...and 10 more locations

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