- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03425006
Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer
August 31, 2023 updated by: University of Pennsylvania
Phase II Study of Pembrolizumab and Itacitinib (INCB039110) for First Line Treatment of Metastatic Non-Small Cell Lung Cancer Expressing PD-L1
This is a single center, single arm phase 2 study to establish the safety and efficacy of itacitinib (also known as INCB039110) administered in combination with pembrolizumab in patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1. Stage IV or metastatic non-small cell lung cancer (NSCLC)
- 2. Provide written informed consent for the trial.
- 3. Patients ≥ 18 years of age
- 4. Tumor PD-L1≥ 50% as assessed by the PD-L1 IHC 22C3 pharmDx assay (Dako North America).
- 5. Subject must have adequate tumor burden at a safely accessible site for biopsy. NOTE: If sites chosen for biopsy were previously irradiated, there must be evidence of tumor growth/viable tumor as assessed by the investigator.
- 6. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- 7. ECOG performance status 0 or 1
- 8. Adequate Organ Function Laboratory Values: Absolute neutrophil count (ANC) ≥1,250/mcL; Platelets ≥100,000/mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L; Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥50 mL/min for subject with creatinine levels > 1.5 X institutional ULN; Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
- 9. Subjects of reproductive potential must agree to use acceptable birth control methods.
Exclusion Criteria:
- 1. Sensitizing mutations in Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) or ROS1 proto-oncogene receptor tyrosine kinase (ROS1) translocations
- 2. Currently participating in or has participated in a study of an investigational agent or anticipated use of an investigational device within 4 weeks of the first dose of study treatment.
- 3. Untreated symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
- 4. Received prior systemic cytotoxic chemotherapy, biologic therapy, targeted therapy or immunotherapy for incurable (metastatic) NSCLC.
- 5. Diagnosis of immunodeficiencywithin 7 days prior to eligibility confirmation by the physician-investigator.
- 6. Prior monoclonal antibodies used for the treatment of NSCLC within 4 weeks prior to eligibility confirmation by the physician-investigator, or individuals who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- 7. Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-invasive bladder tumors, or in situ cervical cancer
- 8. 8. Active autoimmune disease requiring systemic immunosuppressive treatment within the past 3 months prior to eligibility confirmation by the physician-investigator. Subjects that require intermittent use of steroid-containing bronchodilators or local steroid injections or topical steroid medications are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome are not excluded from the study.
- 9. Interstitial lung disease or history of pneumonitis that has required oral or IV steroids
- 10. Active infection requiring systemic therapy with IV antibiotics
- 11. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- 12. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 13. Pregnant or breastfeeding women
- 14. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4).
- 15. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- 16. Known active Hepatitis B (e.g., HBsAg positive or HBV DNA detectable) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- 17. Anticipated receipt of any live vaccine within 30 days prior to the first dose of trial treatment.
Note: For the purposes of determining eligibility above, enrollment is defined as the date of subject consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Itacitinib and Pembrolizumab
|
a JAK 1 selective small molecule inhibitor
Other Names:
a highly selective humanized monoclonal antibody (mAb)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With a Response at 12 Weeks According to RECIST 1.1 for the Combination of Pembrolizumab and Itacitinib Among Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC.
Time Frame: 12 weeks
|
Responses will be compared subject's baseline assessment and historical controls using pembrolizumab monotherapy.
|
12 weeks
|
Number of Subjects With Toxicities (CTCAE v5.0 Scoring) of Pembrolizumab and Itacitinib in Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC
Time Frame: 16 weeks
|
Number of subjects treated with the combination.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.
Time Frame: 12 weeks
|
Number of participants who remained progression free at week 12
|
12 weeks
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Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.
Time Frame: 12 weeks
|
12 weeks
|
|
Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.
Time Frame: 16 weeks
|
Number of subjects treated with pembrolizumab and itacitinib that survived to week 16.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Corey Langer, MD, University of Pennsylvania
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 18, 2018
Primary Completion (Actual)
June 17, 2021
Study Completion (Actual)
October 11, 2021
Study Registration Dates
First Submitted
January 22, 2018
First Submitted That Met QC Criteria
February 5, 2018
First Posted (Actual)
February 7, 2018
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
August 31, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- UPCC# 09517; IRB# 828910
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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