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Janus Kinase (JAK) Inhibitor

Itacitinib + Osimertinib for Lung Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC.
Be older than 18 years old
Must not have
Past history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
Clinically significant or uncontrolled cardiac disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening and 8-week intervals throughout the study, approximately 2 years.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety of using two drugs, itacitinib and osimertinib, together. The study focuses on patients with advanced lung cancer that has spread. Itacitinib helps the immune system fight cancer, while osimertinib targets and kills specific cancer cells. Osimertinib is approved for treating a specific type of lung cancer, even in cases where the cancer has become resistant to other treatments.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) who have a specific EGFR mutation and have progressed after treatment with an EGFR tyrosine kinase inhibitor. They must not have untreated brain metastases, significant heart disease, or a history of certain lung conditions. Only one prior line of therapy for NSCLC is allowed in Phase 2.
What is being tested?
The study tests the safety and effectiveness of combining Itacitinib with Osimertinib in treating NSCLC. Participants will receive both drugs to see how well they work together against lung cancer that has worsened despite previous treatments.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, increased risk of infections due to immune system effects, liver issues, nausea, fatigue, and possibly other organ-related inflammations as seen with similar medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is at an advanced stage and cannot be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had lung conditions like ILD or radiation pneumonitis that needed steroids.
Select...
I do not have any major or unmanaged heart conditions.
Select...
My brain scans show no new or growing cancer spots.
Select...
I have used JAK inhibitors or EGFR-targeted therapies for my lung cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening and 8-week intervals throughout the study, approximately 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening and 8-week intervals throughout the study, approximately 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 2: Objective response rate (ORR) based on RECIST v1.1
Secondary study objectives
Phase 2: Depth of response (DpR) based on RECIST v1.1

Side effects data

From 2020 Phase 3 trial • 439 Patients • NCT03139604
34%
Thrombocytopenia
29%
Anaemia
25%
Oedema peripheral
22%
Hyperglycaemia
21%
Hypertension
20%
Diarrhoea
19%
Hypokalaemia
18%
Platelet count decreased
18%
Nausea
17%
Neutropenia
16%
Cytomegalovirus viraemia
16%
Pyrexia
15%
Cough
14%
Alanine aminotransferase increased
14%
Hypertriglyceridaemia
13%
Dyspnoea
13%
Fatigue
13%
Hypomagnesaemia
13%
Tremor
12%
Cytomegalovirus infection reactivation
12%
Abdominal pain
12%
Blood creatinine increased
12%
Constipation
11%
Decreased appetite
11%
Arthralgia
11%
Aspartate aminotransferase increased
11%
Dizziness
11%
Muscular weakness
11%
Vomiting
10%
Insomnia
9%
Fall
9%
Headache
8%
Upper respiratory tract infection
8%
Dry eye
8%
Dysuria
8%
Anxiety
8%
Back pain
7%
Hypotension
7%
Blood cholesterol increased
7%
Hyponatraemia
7%
Hypophosphataemia
7%
Pain in extremity
7%
Urinary tract infection
7%
Hypocalcaemia
7%
Neutrophil count decreased
7%
Dry mouth
7%
Cytomegalovirus infection
6%
Hypoalbuminaemia
6%
Pruritus
6%
White blood cell count decreased
6%
Asthenia
6%
Blood alkaline phosphatase increased
5%
Acute kidney injury
5%
Pneumonia
5%
Gamma-glutamyltransferase increased
5%
Oral candidiasis
5%
Rash
5%
Weight decreased
5%
Pancytopenia
5%
Dysgeusia
5%
Dyspepsia
5%
Epstein-Barr virus infection reactivation
4%
Hyperkalaemia
4%
Epistaxis
3%
Febrile neutropenia
3%
Oedema
3%
Rhinorrhoea
3%
Dry skin
3%
Leukopenia
3%
Nasopharyngitis
3%
Neuropathy peripheral
3%
Vision blurred
2%
Cystitis haemorrhagic
2%
Syncope
2%
Sepsis
1%
Graft versus host disease in gastrointestinal tract
1%
Thrombotic microangiopathy
1%
Viral haemorrhagic cystitis
1%
Bronchopulmonary aspergillosis
1%
Adenovirus infection
1%
Escherichia sepsis
1%
Failure to thrive
1%
Malignant neoplasm progression
1%
Ophthalmic herpes zoster
1%
Oral herpes
1%
Pulmonary embolism
1%
Septic shock
1%
Pneumonia influenzal
1%
Myopathy
1%
Steroid diabetes
1%
Pseudomonal sepsis
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Itacitinib Plus Corticosteroids
Placebo Plus Corticosteroids
Total

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Itacitinib + osimertinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itacitinib
2020
Completed Phase 3
~980
Osimertinib
2017
Completed Phase 4
~1120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Itacitinib, a JAK1 inhibitor, works by blocking the Janus kinase 1 pathway, which can reduce inflammation and inhibit cancer cell growth. Osimertinib, an EGFR inhibitor, targets mutations in the epidermal growth factor receptor common in non-small cell lung cancer (NSCLC), blocking signals that promote cancer cell proliferation. These mechanisms are crucial for lung cancer patients as they allow for targeted therapy, potentially leading to more effective and personalized treatment options, improving outcomes and reducing side effects compared to traditional chemotherapy.
An overview of osimertinib as a treatment of non-small cell lung cancer (NSCLC): an update.Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Mutation: First Line Treatment and Beyond.

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,403 Previous Clinical Trials
289,125,021 Total Patients Enrolled
Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,776 Total Patients Enrolled
Peter LangmuirStudy DirectorIncyte Corporation
2 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

Itacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02917993 — Phase 1 & 2
Lung Cancer Research Study Groups: Itacitinib + osimertinib
Lung Cancer Clinical Trial 2023: Itacitinib Highlights & Side Effects. Trial Name: NCT02917993 — Phase 1 & 2
Itacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02917993 — Phase 1 & 2
~7 spots leftby Dec 2025