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Non Small Cell Lung CancerPhase 1NCT04274907

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 testing Venetoclax and Pembrolizumab in people with Non Small Cell Lung Cancer and Cancer, run by AbbVie at 39 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer, Cancer
What is being tested?
Venetoclax and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
39 sitesUnited States
Study dates
30 Jun 2020to 2 Feb 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Ashland-Bellefonte Cancer Ctr /ID# 218511

    Ashland, Kentucky, 41101

  • Georgia Regents University /ID# 217109

    Augusta, Georgia, 30912

  • Univ of Alabama at Birmingham /ID# 214180

    Birmingham, Alabama, 35233

  • Rush University Medical Center /ID# 212448

    Chicago, Illinois, 60612

  • University of Chicago DCAM /ID# 214319

    Chicago, Illinois, 60637-1443

  • University of Cincinnati Cancer Institute /ID# 216800

    Cincinnati, Ohio, 45219-2364

  • University Hospitals Cleveland /ID# 212241

    Cleveland, Ohio, 44106

  • Maryland Oncology Hematology /ID# 214131

    Columbia, Maryland, 21044-3128

  • The Ohio State University - The James /ID# 212298

    Columbus, Ohio, 43210-1240

  • Karmanos Cancer Institute /ID# 216986

    Detroit, Michigan, 48201

  • Henry Ford Health System /ID# 216385

    Detroit, Michigan, 48202

  • Virginia Cancer Specialists /ID# 214328

    Fairfax, Virginia, 22031

  • Fort Wayne Medical Oncology /ID# 214954

    Fort Wayne, Indiana, 46804

  • Prisma Health Cancer Institute - Faris /ID# 217946

    Greenville, South Carolina, 29605-4255

  • Hackensack Univ Med Ctr /ID# 216484

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hosp /ID# 214952

    Harvey, Illinois, 60426

  • Houston Methodist Hospital - Scurlock Tower /ID# 215481

    Houston, Texas, 77030

  • Univ of Mississippi Med Ctr /ID# 216429

    Jackson, Mississippi, 39216-4500

  • Thompson Cancer Survival Ctr /ID# 217076

    Knoxville, Tennessee, 37916

  • Central Maine Medical Center /ID# 216107

    Lewiston, Maine, 04240

  • University of Louisville /ID# 215195

    Louisville, Kentucky, 40202

  • Atlantic Health System /ID# 217067

    Morristown, New Jersey, 07960-6136

  • 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

  • Methodist Estabrook Cancer Center /ID# 216910

    Omaha, Nebraska, 68114-4108

  • University of Nebraska Medical Center /ID# 216754

    Omaha, Nebraska, 68198-6840

  • AdventHealth Cancer Institute - Orlando /ID# 214444

    Orlando, Florida, 32804

  • Allegheny General Hospital /ID# 214363

    Pittsburgh, Pennsylvania, 15212

  • Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 215497

    Portland, Oregon, 97225

  • Massey Cancer Centre /ID# 212527

    Richmond, Virginia, 23298

  • Utah Cancer Specialists /ID# 215496

    Salt Lake City, Utah, 84106

  • St Jude Hospital dba St Joseph /ID# 212360

    Santa Rosa, California, 95403

  • Washington University-School of Medicine /ID# 212355

    St Louis, Missouri, 63110

  • Overlook Medical Center /ID# 219108

    Summit, New Jersey, 07901-3533

  • Multicare Institute for Research and Innovation /ID# 217913

    Tacoma, Washington, 98405

  • Northwest Medical Specialties /ID# 218484

    Tacoma, Washington, 98405

  • Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 216984

    Tucson, Arizona, 85704

  • Icri /Id# 217071

    Whittier, California, 90603

  • University of Massachusetts Ca /ID# 218744

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

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.

Read more

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.

Keywords
Non Small Cell Lung Cancer (NSCLC), Cancer, Venetoclax, Pembrolizumab, PD-L1 Expression, ABT-199
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called Venclexta, ABT-199

    Tablet: Oral

  • PembrolizumabDrug

    Also called Keytruda

    Intravenous (IV) Infusion

Study groups in NCT04274907
Study groupRoleWhat they receive
Dose Escalation Phase: Venetoclax + PembrolizumabExperimentalParticipants will receive escalating doses of venetoclax in combination with pembrolizumab Dose A.
Receives: Drug: Venetoclax; Drug: Pembrolizumab
Randomization Phase: Venetoclax + PembrolizumabExperimentalParticipants will receive venetoclax at dose levels determined in the dose escalation phase in combination with pembrolizumab Dose A.
Receives: Drug: Venetoclax; Drug: Pembrolizumab
Randomization Phase: Pembrolizumab MonotherapyActive comparatorParticipants will receive pembrolizumab Dose A
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 Days

  2. Change in the Sum of the Longest Diameter (SLD)

    Change in the SLD is assessed by exposure-response modeling

    Measured: Up to 35 Cycles (Each Cycle is 21 Days)

Secondary outcomes (4)

  1. Maximum Plasma Concentration (Cmax) of Venetoclax

    Maximum plasma concentration (Cmax) of venetoclax

    Measured: Up to Cycle 1 (Each Cycle is 21 Days)

  2. Time to Maximum Observed Plasma Concentration (Tmax) of Venetoclax

    Time to maximum observed plasma concentration (Tmax) of venetoclax

    Measured: Up to Cycle 1 (Each Cycle is 21 Days)

  3. Area Under the Plasma Concentration-Time Curve Over Time from 0 to 24 (AUC0-24) of Venetoclax in Plasma

    Area Under the Plasma Concentration-time Curve (AUC) from 0-24 (AUC0-24)

    Measured: Up to Cycle 1 (Each Cycle is 21 Days)

  4. Objective Response Rate (ORR)

    ORR will be defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR).

    Measured: Up to 35 Cycles (Each Cycle is 21 Days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2020
  2. Study start30 Jun 2020
  3. Primary completion2 Feb 2021
  4. Study completion2 Feb 2021

Why it stopped: Company Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274907
Sponsor's protocol ID
M19-700
Status last verified
Feb 2021
First submitted
17 Feb 2020
Last updated
11 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Venetoclax and Pembrolizumab in people with Non Small Cell Lung Cancer and Cancer, run by AbbVie at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Company Decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Up to 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04274907.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

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