Study Stopped
Company Decision
A Safety Study of Oral Venetoclax in Combination With Intravenous Pembrolizumab in Adult Participants With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) With High Programmed Cell Death Ligand-1 (PD-L1) Expression
A Phase 1b Study of Venetoclax in Combination With Pembrolizumab in Subjects With Previously Untreated NSCLC Whose Tumors Have High PD-L1 Expression
1 other identifier
interventional
2
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2020
Shorter than P25 for phase_1
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2021
CompletedFebruary 11, 2021
February 1, 2021
7 months
February 17, 2020
February 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Up to 28 Days
Change in the Sum of the Longest Diameter (SLD)
Change in the SLD is assessed by exposure-response modeling
Up to 35 Cycles (Each Cycle is 21 Days)
Secondary Outcomes (4)
Maximum Plasma Concentration (Cmax) of Venetoclax
Up to Cycle 1 (Each Cycle is 21 Days)
Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax
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
Up to Cycle 1 (Each Cycle is 21 Days)
Objective Response Rate (ORR)
Up to 35 Cycles (Each Cycle is 21 Days)
Study Arms (3)
Dose Escalation Phase: Venetoclax + Pembrolizumab
EXPERIMENTALParticipants will receive escalating doses of venetoclax in combination with pembrolizumab Dose A.
Randomization Phase: Venetoclax + Pembrolizumab
EXPERIMENTALParticipants will receive venetoclax at dose levels determined in the dose escalation phase in combination with pembrolizumab Dose A.
Randomization Phase: Pembrolizumab Monotherapy
ACTIVE COMPARATORParticipants will receive pembrolizumab Dose A
Interventions
Tablet: Oral
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- Histologically documented advanced or metastatic NSCLC with no known epidermal growth factor receptor (EGFR) sensitizing (activating) mutation or anaplastic lymphoma kinase (ALK) translocation.
- At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
- High PD-L1 tumor expression (tumor proportion score \>= 50%) as determined by a Food and Drug Administration (FDA)-approved test.
- Willing to provide tissue biopsy sample prior to start of study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You may not qualify if:
- Received prior systemic treatment for their advanced or metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
- History of or ongoing interstitial lung disease or pneumonitis that required oral or intravenous (IV) steroids.
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a participant has signs/symptoms suggestive of SARS-CoV-2 infection, they should undergo molecular (e.g., polymerase chain reaction \[PCR\]) testing to rule out SARS-CoV-2 infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (39)
Univ of Alabama at Birmingham /ID# 214180
Birmingham, Alabama, 35233, United States
Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 216984
Tucson, Arizona, 85704, United States
St Jude Hospital dba St Joseph /ID# 212360
Santa Rosa, California, 95403, United States
Icri /Id# 217071
Whittier, California, 90603, United States
AdventHealth Cancer Institute - Orlando /ID# 214444
Orlando, Florida, 32804, United States
Georgia Regents University /ID# 217109
Augusta, Georgia, 30912, United States
Rush University Medical Center /ID# 212448
Chicago, Illinois, 60612, United States
University of Chicago DCAM /ID# 214319
Chicago, Illinois, 60637-1443, United States
Ingalls Memorial Hosp /ID# 214952
Harvey, Illinois, 60426, United States
Fort Wayne Medical Oncology /ID# 214954
Fort Wayne, Indiana, 46804, United States
Ashland-Bellefonte Cancer Ctr /ID# 218511
Ashland, Kentucky, 41101, United States
University of Louisville /ID# 215195
Louisville, Kentucky, 40202, United States
Central Maine Medical Center /ID# 216107
Lewiston, Maine, 04240, United States
Maryland Oncology Hematology /ID# 214131
Columbia, Maryland, 21044-3128, United States
University of Massachusetts Ca /ID# 218744
Worcester, Massachusetts, 01655, United States
Karmanos Cancer Institute /ID# 216986
Detroit, Michigan, 48201, United States
Henry Ford Health System /ID# 216385
Detroit, Michigan, 48202, United States
Univ of Mississippi Med Ctr /ID# 216429
Jackson, Mississippi, 39216-4500, United States
Washington University-School of Medicine /ID# 212355
St Louis, Missouri, 63110, United States
Methodist Estabrook Cancer Center /ID# 216910
Omaha, Nebraska, 68114-4108, United States
University of Nebraska Medical Center /ID# 216754
Omaha, Nebraska, 68198-6840, United States
Hackensack Univ Med Ctr /ID# 216484
Hackensack, New Jersey, 07601, United States
Atlantic Health System /ID# 217067
Morristown, New Jersey, 07960-6136, United States
Overlook Medical Center /ID# 219108
Summit, New Jersey, 07901-3533, United States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 218077
New York, New York, 10016-4744, United States
Weill Cornell Medical Center /ID# 216911
New York, New York, 10065, United States
University of Cincinnati Cancer Institute /ID# 216800
Cincinnati, Ohio, 45219-2364, United States
University Hospitals Cleveland /ID# 212241
Cleveland, Ohio, 44106, United States
The Ohio State University - The James /ID# 212298
Columbus, Ohio, 43210-1240, United States
Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 215497
Portland, Oregon, 97225, United States
Allegheny General Hospital /ID# 214363
Pittsburgh, Pennsylvania, 15212, United States
Prisma Health Cancer Institute - Faris /ID# 217946
Greenville, South Carolina, 29605-4255, United States
Thompson Cancer Survival Ctr /ID# 217076
Knoxville, Tennessee, 37916, United States
Houston Methodist Hospital - Scurlock Tower /ID# 215481
Houston, Texas, 77030, United States
Utah Cancer Specialists /ID# 215496
Salt Lake City, Utah, 84106, United States
Virginia Cancer Specialists /ID# 214328
Fairfax, Virginia, 22031, United States
Massey Cancer Centre /ID# 212527
Richmond, Virginia, 23298, United States
Multicare Institute for Research and Innovation /ID# 217913
Tacoma, Washington, 98405, United States
Northwest Medical Specialties /ID# 218484
Tacoma, Washington, 98405, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2020
First Posted
February 18, 2020
Study Start
June 30, 2020
Primary Completion
February 2, 2021
Study Completion
February 2, 2021
Last Updated
February 11, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share