Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. It is the most common form of lung cancer, accounting for around 85% of lung cancers. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of venetoclax in combination with pembrolizumab in participants with NSCLC. Venetoclax is a drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. Pembrolizumab is approved drug for the treatment of NSCLC. It works with your immune system to help fight certain cancers. The study is split into two portions - dose escalation and randomization. Participants are assigned one of the three treatment groups to receive pembrolizumab alone or in combination with venetoclax. Each group receives a different treatment. Participants who are at least 18 years of age with a diagnosis of NSCLC will be enrolled. Around 100 participants will be enrolled in the study in approximately 44 sites across United States. Participants will receive intravenous (IV) infusion of pembrolizumab alone or in combination with oral venetoclax tablets. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Tablet: Oral
Intravenous (IV) Infusion
Univ of Alabama at Birmingham /ID# 214180
Birmingham, Alabama, United States
Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 216984
Tucson, Arizona, United States
St Jude Hospital dba St Joseph /ID# 212360
Santa Rosa, California, United States
Icri /Id# 217071
Whittier, California, United States
AdventHealth Cancer Institute - Orlando /ID# 214444
Orlando, Florida, United States
Number of Participants with Dose-Limiting Toxicities (DLTs)
DLTs are adverse events that are considered to have a reasonable possibility of relationship to the administration of venetoclax and pembrolizumab and cannot be attributed by the investigator to a clearly identifiable cause such as disease progression, concurrent illness or concomitant medication.
Time frame: Up to 28 Days
Change in the Sum of the Longest Diameter (SLD)
Change in the SLD is assessed by exposure-response modeling
Time frame: Up to 35 Cycles (Each Cycle is 21 Days)
Maximum Plasma Concentration (Cmax) of Venetoclax
Maximum plasma concentration (Cmax) of venetoclax
Time frame: Up to Cycle 1 (Each Cycle is 21 Days)
Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
Time to maximum observed plasma concentration (Tmax) of venetoclax
Time frame: Up to Cycle 1 (Each Cycle is 21 Days)
Area Under the Plasma Concentration-Time Curve Over Time from 0 to 24 (AUC0-24) of Venetoclax in Plasma
Area Under the Plasma Concentration-time Curve (AUC) from 0-24 (AUC0-24)
Time frame: Up to Cycle 1 (Each Cycle is 21 Days)
Objective Response Rate (ORR)
ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR).
Time frame: Up to 35 Cycles (Each Cycle is 21 Days)
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Georgia Regents University /ID# 217109
Augusta, Georgia, United States
Rush University Medical Center /ID# 212448
Chicago, Illinois, United States
University of Chicago DCAM /ID# 214319
Chicago, Illinois, United States
Ingalls Memorial Hosp /ID# 214952
Harvey, Illinois, United States
Fort Wayne Medical Oncology /ID# 214954
Fort Wayne, Indiana, United States
...and 29 more locations