Your session is about to expire
← Back to Search
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening and 8-week intervals throughout the study, approximately 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening and 8-week intervals throughout the study, approximately 2 years.
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 • NCT0313960434%
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on a stable or decreasing dose of corticosteroids for at least 4 weeks.I haven't had any cancer except for certain skin, bladder, prostate, cervical, or other noninvasive cancers in the last 2 years.I am not currently undergoing any cancer treatments.You have important irregularities in your heart's electrical activity as shown on an ECG.I have had lung conditions like ILD or radiation pneumonitis that needed steroids.I do not have any major or unmanaged heart conditions.I am at least 18 years old, or older if required by my country's laws.My cancer has a specific EGFR mutation confirmed by a test.My lung cancer worsened after treatment with an EGFR inhibitor.My cancer progressed after EGFR TKI treatment, and I have a T790M mutation.I've had only one treatment for advanced lung cancer, which included an EGFR inhibitor.My brain metastases are stable and not causing symptoms.My brain scans show no new or growing cancer spots.Your disease can be measured or evaluated using specific radiographic criteria.My lung cancer is at an advanced stage and cannot be surgically removed.Your lab test results are not within the specified range set by the study.I have used JAK inhibitors or EGFR-targeted therapies for my lung cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Itacitinib + osimertinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger