A Phase 2 Umbrella Study with Rolling Arms of Investigational Agents with either Pembrolizumab in Combination with Chemotherapy or with Pembrolizumab Alone in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Brief description of study

The purpose of the study is to determine how well different drugs work in a single type of cancer for patients with advanced NSCLC. This research study, called an “umbrella” study, has several different study treatment groups (called study treatment arms) within one study. In umbrella studies, subjects are assigned to a specific group and study treatment based on factors such as prior treatments received for cancer and the type of cancer. This study will test investigational drugs (not approved for sale) together with pembrolizumab (MK-3475), also known as KEYTRUDA® and standard chemotherapy or with pembrolizumab alone. Additional investigational drugs may be added to a sub-study on a rolling basis but only after testing of the investigational drug in other studies is completed and a recommended dose has been chosen for use in this study. The combination of the investigational drug(s) and pembrolizumab with chemotherapy or pembrolizumab alone is considered investigational, which means that they have not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.


Clinical Study Identifier: s19-01683
ClinicalTrials.gov Identifier: NCT04165798
Principal Investigator: Vamsidhar Velcheti.


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