KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

ConditionCarcinoma, Non-Small-Cell Lung

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Male and female participants with histologically-confirmed diagnosis of squamous or nonsquamous NSCLC

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

1,065 Participants

are divided into 1 treatment group

Group A: Prospective NSCLC Participants3 interventions

Trial outcomes

Primary outcomes

Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1%

Participants' tumors will be evaluated for their PD-L1 tumor expression level using archival tumor tissue samples or newly obtained tumor tissue. The percentage of participants who have a Tumor Proportion Score (TPS) \<1% vs. a TPS =1% will be presented.

Time frame

Up to approximately 1 month

Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC

Participants' tumors will be evaluated for their tumor histology status as being either squamous vs. nonsquamous NSCLC using archival or newly obtained tumor tissue samples. The percentage of participants who have squamous vs. nonsquamous NSCLC will be presented.

Time frame

Up to approximately 1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator

Source ClinicalTrials.gov

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