Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

2

Study ID:

NCT04274907

Recruitment Status:

Terminated

Sponsor:

AbbVie

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There are 38 Locations for this study

See Locations Near You

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, 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, 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, United States
Washington University-School of Medicine /ID# 212355
Saint Louis Missouri, 63110, United States
Methodist Estabrook Cancer Center /ID# 216910
Omaha Nebraska, 68114, United States
University of Nebraska Medical Center /ID# 216754
Omaha Nebraska, 68198, United States
Hackensack Univ Med Ctr /ID# 216484
Hackensack New Jersey, 07601, United States
Atlantic Health System /ID# 217067
Morristown New Jersey, 07960, United States
Overlook Medical Center /ID# 219108
Summit New Jersey, 07901, United States
NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 218077
New York New York, 10016, 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, United States
University Hospitals Cleveland /ID# 212241
Cleveland Ohio, 44106, United States
The Ohio State University - The James /ID# 212298
Columbus Ohio, 43210, 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, 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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

2

Study ID:

NCT04274907

Recruitment Status:

Terminated

Sponsor:


AbbVie

How clear is this clinincal trial information?

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