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Pembrolizumab and Itacitinib (INCB039110) for NSCLC

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ClinicalTrials.gov Identifier: NCT03425006
Recruitment Status : Active, not recruiting
First Posted : February 7, 2018
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Itacitinib Biological: Pembrolizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pembrolizumab and Itacitinib (INCB039110) for First Line Treatment of Metastatic Non-Small Cell Lung Cancer Expressing PD-L1
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Itacitinib and Pembrolizumab Drug: Itacitinib
a JAK 1 selective small molecule inhibitor
Other Name: INCB039110

Biological: Pembrolizumab
a highly selective humanized monoclonal antibody (mAb)




Primary Outcome Measures :
  1. Response Rate 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.

  2. Evaluate toxicities (CTCAE v5.0 scoring) of pembrolizumab and itacitinib in patients with previously untreated, PD-L1 positive metastatic NSCLC [ Time Frame: 36 Months ]

Secondary Outcome Measures :
  1. Median progression free survival (PFS) for subjects treated with pembrolizumab and itacitinib. [ Time Frame: 36 Months ]
  2. Duration of response (DOR) for subjects treated with pembrolizumab and itacitinib. [ Time Frame: 36 Months ]
  3. Overall survival (OS) for subjects treated with pembrolizumab and itacitinib. [ Time Frame: 36 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425006


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Joshua Bauml, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03425006    
Other Study ID Numbers: UPCC# 09517; IRB# 828910
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents