Non Small Cell Lung CancerPhase 2NCT03425006
Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer
A Phase 2 study testing Itacitinib and Pembrolizumab in people with Non Small Cell Lung Cancer, run by University of Pennsylvania at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Itacitinib and Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 11 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Itacitinib, Pembrolizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
a JAK 1 selective small molecule inhibitor
PembrolizumabBiological
a highly selective humanized monoclonal antibody (mAb)
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib and Pembrolizumab | Experimental | Not described Receives: Drug: Itacitinib; Biological: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Responses will be compared subject's baseline assessment and historical controls using pembrolizumab monotherapy.
Measured: 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
Number of subjects treated with the combination.
Measured: 16 weeks
Secondary outcomes (3)
Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.
Number of participants who remained progression free at week 12
Measured: 12 weeks
Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.
Measured: 12 weeks
Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.
Number of subjects treated with pembrolizumab and itacitinib that survived to week 16.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start18 Jun 2018
- Primary completion17 Jun 2021
- Study completion11 Oct 2021
Why it stopped: Administrative reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corey Langer, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425006
- Sponsor's protocol ID
- UPCC# 09517; IRB# 828910
- Status last verified
- Aug 2023
- First submitted
- 22 Jan 2018
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pembrolizumab and Itacitinib (INCB039110) for First Line Treatment of Metastatic Non-Small Cell Lung Cancer Expressing PD-L1
- ClinicalTrials.gov ID
- NCT03425006
- Acronym / sponsor ID
- UPCC# 09517; IRB# 828910
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Posted 13 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Itacitinib and Pembrolizumab | Experimental | Drug: Itacitinib, Biological: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ItacitinibAlso: INCB039110a JAK 1 selective small molecule inhibitor | Drug | Itacitinib and Pembrolizumab |
| Pembrolizumaba highly selective humanized monoclonal antibody (mAb) | Biological | Itacitinib and Pembrolizumab |
Primary outcome
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.
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.
3 secondary outcomes
Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.
Time frame: 12 weeks
Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.
Time frame: 12 weeks
Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey Langer, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Itacitinib and Pembrolizumab in people with Non Small Cell Lung Cancer, run by University of Pennsylvania at 1 site 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 9 inclusion and 18 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 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). 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?
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 13 Sep 2023.