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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening and 8-week intervals throughout the study, approximately 2 years.
Awards & highlights
Study Summary
This trial will test if a new combination therapy of itacitinib and osimertinib is safe and tolerable for patients with locally advanced or metastatic NSCLC.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Frequency, severity, and duration of adverse events (AEs)
Phase 1: Number of subjects with dose-limiting toxicities (DLTs)
Phase 2: Objective response rate (ORR) based on RECIST v1.1
Secondary outcome measures
Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC) of Itacitinib and osimertinib when administered in combination
Phase 1 and Phase 2: Maximum plasma concentration (Cmax) of itacitinib and osimertinib when administered in combination
Phase 2: Depth of response (DpR) based on RECIST v1.1
+3 moreSide 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%
Blood cholesterol increased
7%
Hypotension
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%
Thrombotic microangiopathy
1%
Graft versus host disease in gastrointestinal tract
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
Placebo Plus Corticosteroids
Itacitinib Plus Corticosteroids
Total
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
~910
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,257 Previous Clinical Trials
288,593,727 Total Patients Enrolled
Incyte CorporationLead Sponsor
364 Previous Clinical Trials
55,106 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients still being accepted for this clinical trial?
"Currently, this study is not looking for any more participants. However, it's important to note that the clinical trial was originally posted on December 20th 2016 and was most recently updated on October 17th 2022. If you're interested in other studies, there are 2101 trials for lung cancer and 127 for Itacitinib currently enrolling patients."
Answered by AI
Is this trial limited to a few clinics in the city, or is it more widespread?
"There are a total of 23 running clinical trials for this medication, they are located at the University of Texas - MD Anderson Cancer Center in Houston, the University of California San Diego in La Jolla, and Cleveland Clinic in Cleveland. Along with these three locations, there are 20 other sites where the trial is taking place."
Answered by AI
Does the medical literature support Itacitinib's efficacy?
"Itacitinib was first researched in 2013 atResearch Site. As of now, 41 studies have completed and 127 are still ongoing with numerous clinical sites based in Houston, Texas."
Answered by AI
What is the total pool of research participants for this project?
"Unfortunately, this study is not enrolling patients at the moment. The listing was created on December 20th, 2016 but was last updated on October 17th, 2022. Although this trial isn't currently searching for participants, there are 2101 other trials related to lung cancer and 127 studies involving Itacitinib that are still recruiting patients."
Answered by AI
Have researchers conducted similar trials in the past?
"Clinical trials for Itacitinib began in 2013 and was first sponsored by AstraZeneca. After the 603-person Phase 1 & 2 study, it received drug approval. As of now, 127 studies are active across 1064 cities and 51 countries."
Answered by AI
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