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NCT04274907 · ClinicalTrials.gov registry record · Phase 1
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 1 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04274907 is a Phase 1 study that was terminated before completion, run by AbbVie. The registered enrollment target is 2 participants.
The verdict
NCT04274907, a Phase 1 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- DRUG Venetoclax
- DRUG Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2021-02-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04274907
The ClinicalTrials.gov registry entry for NCT04274907 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Venetoclax is the first listed.
NCT04274907 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04274907 about?
NCT04274907 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04274907?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2020-06-30. Estimated completion is 2021-02-02.
What interventions are being tested in trial NCT04274907?
The interventions under investigation include: Venetoclax (DRUG), Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT04274907?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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