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
Public ClinicalTrials.gov record NCT04274907. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1b Study of Venetoclax in Combination With Pembrolizumab in Subjects With Previously Untreated NSCLC Whose Tumors Have High PD-L1 Expression
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04274907
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 2 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2020 (Actual)
- Primary completion
- Feb 2, 2021 (Actual)
- Completion
- Feb 2, 2021 (Actual)
- Last update posted
- Feb 11, 2021
2020 – 2021
United States locations
- U.S. sites
- 39
- U.S. states
- 26
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama at Birmingham /ID# 214180 | Birmingham | Alabama | 35233 | — |
| Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 216984 | Tucson | Arizona | 85704 | — |
| St Jude Hospital dba St Joseph /ID# 212360 | Santa Rosa | California | 95403 | — |
| Icri /Id# 217071 | Whittier | California | 90603 | — |
| AdventHealth Cancer Institute - Orlando /ID# 214444 | Orlando | Florida | 32804 | — |
| Georgia Regents University /ID# 217109 | Augusta | Georgia | 30912 | — |
| Rush University Medical Center /ID# 212448 | Chicago | Illinois | 60612 | — |
| University of Chicago DCAM /ID# 214319 | Chicago | Illinois | 60637-1443 | — |
| Ingalls Memorial Hosp /ID# 214952 | Harvey | Illinois | 60426 | — |
| Fort Wayne Medical Oncology /ID# 214954 | Fort Wayne | Indiana | 46804 | — |
| Ashland-Bellefonte Cancer Ctr /ID# 218511 | Ashland | Kentucky | 41101 | — |
| University of Louisville /ID# 215195 | Louisville | Kentucky | 40202 | — |
| Central Maine Medical Center /ID# 216107 | Lewiston | Maine | 04240 | — |
| Maryland Oncology Hematology /ID# 214131 | Columbia | Maryland | 21044-3128 | — |
| University of Massachusetts Ca /ID# 218744 | Worcester | Massachusetts | 01655 | — |
| Karmanos Cancer Institute /ID# 216986 | Detroit | Michigan | 48201 | — |
| Henry Ford Health System /ID# 216385 | Detroit | Michigan | 48202 | — |
| Univ of Mississippi Med Ctr /ID# 216429 | Jackson | Mississippi | 39216-4500 | — |
| Washington University-School of Medicine /ID# 212355 | St Louis | Missouri | 63110 | — |
| Methodist Estabrook Cancer Center /ID# 216910 | Omaha | Nebraska | 68114-4108 | — |
| University of Nebraska Medical Center /ID# 216754 | Omaha | Nebraska | 68198-6840 | — |
| Hackensack Univ Med Ctr /ID# 216484 | Hackensack | New Jersey | 07601 | — |
| Atlantic Health System /ID# 217067 | Morristown | New Jersey | 07960-6136 | — |
| Overlook Medical Center /ID# 219108 | Summit | New Jersey | 07901-3533 | — |
| NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 218077 | New York | New York | 10016-4744 | — |
| Weill Cornell Medical Center /ID# 216911 | New York | New York | 10065 | — |
| University of Cincinnati Cancer Institute /ID# 216800 | Cincinnati | Ohio | 45219-2364 | — |
| University Hospitals Cleveland /ID# 212241 | Cleveland | Ohio | 44106 | — |
| The Ohio State University - The James /ID# 212298 | Columbus | Ohio | 43210-1240 | — |
| Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 215497 | Portland | Oregon | 97225 | — |
| Allegheny General Hospital /ID# 214363 | Pittsburgh | Pennsylvania | 15212 | — |
| Prisma Health Cancer Institute - Faris /ID# 217946 | Greenville | South Carolina | 29605-4255 | — |
| Thompson Cancer Survival Ctr /ID# 217076 | Knoxville | Tennessee | 37916 | — |
| Houston Methodist Hospital - Scurlock Tower /ID# 215481 | Houston | Texas | 77030 | — |
| Utah Cancer Specialists /ID# 215496 | Salt Lake City | Utah | 84106 | — |
| Virginia Cancer Specialists /ID# 214328 | Fairfax | Virginia | 22031 | — |
| Massey Cancer Centre /ID# 212527 | Richmond | Virginia | 23298 | — |
| Multicare Institute for Research and Innovation /ID# 217913 | Tacoma | Washington | 98405 | — |
| Northwest Medical Specialties /ID# 218484 | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04274907, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 11, 2021 · Synced Oct 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04274907 live on ClinicalTrials.gov.