Status:
TERMINATED
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
Lead Sponsor:
AbbVie
Conditions:
Non Small Cell Lung Cancer
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 cance...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04274907
Start Date
June 30 2020
End Date
February 2 2021
Last Update
February 11 2021
Active Locations (39)
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1
Univ of Alabama at Birmingham /ID# 214180
Birmingham, Alabama, United States, 35233
2
Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 216984
Tucson, Arizona, United States, 85704
3
St Jude Hospital dba St Joseph /ID# 212360
Santa Rosa, California, United States, 95403
4
Icri /Id# 217071
Whittier, California, United States, 90603