What side effects are associated with this type of intervention?

Common treatments for lung cancer, particularly those involving JAK1 and EGFR inhibitors like Itacitinib and Osimertinib, often have side effects such as fatigue, nausea, diarrhea, and increased liver function tests. Osimertinib, an EGFR inhibitor, can also cause rash, dry skin, and more severe effects like interstitial lung disease. JAK1 inhibitors like Itacitinib may lead to immunosuppression, increasing the risk of infections. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Osimertinib, an EGFR inhibitor, is FDA-approved for the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations. Other EGFR inhibitors approved for NSCLC include gefitinib and erlotinib. Additionally, sotorasib, a KRAS G12C inhibitor, is approved for KRAS-mutated NSCLC. Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, is also approved for NSCLC with PD-L1 expression. These treatments represent the targeted and immunotherapy approaches in lung cancer management.

What other types of research exist?

Promising novel alternatives for lung cancer treatment in 2024 include: 1) Amivantamab, a bispecific antibody targeting EGFR and MET, which has shown efficacy in EGFR-mutant NSCLC. 2) Mobocertinib, an oral EGFR inhibitor specifically targeting EGFR exon 20 insertion mutations. 3) KRAS G12C inhibitors such as Sotorasib and Adagrasib, which target a common mutation in NSCLC. 4) Immune checkpoint inhibitors like Pembrolizumab and Nivolumab, which continue to show promise in various combinations and settings.

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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

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 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.

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

Fall

Headache

Upper respiratory tract infection

Dry eye

Dysuria

Anxiety

Back pain

Blood cholesterol increased

Hypotension

Hyponatraemia

Hypophosphataemia

Pain in extremity

Urinary tract infection

Hypocalcaemia

Neutrophil count decreased

Dry mouth

Cytomegalovirus infection

Hypoalbuminaemia

Pruritus

White blood cell count decreased

Asthenia

Blood alkaline phosphatase increased

Acute kidney injury

Pneumonia

Gamma-glutamyltransferase increased

Oral candidiasis

Rash

Weight decreased

Pancytopenia

Dysgeusia

Dyspepsia

Epstein-Barr virus infection reactivation

Hyperkalaemia

Epistaxis

Febrile neutropenia

Oedema

Rhinorrhoea

Dry skin

Leukopenia

Nasopharyngitis

Neuropathy peripheral

Vision blurred

Cystitis haemorrhagic

Syncope

Sepsis

Graft versus host disease in gastrointestinal tract

Thrombotic microangiopathy

Viral haemorrhagic cystitis

Bronchopulmonary aspergillosis

Adenovirus infection

Escherichia sepsis

Failure to thrive

Malignant neoplasm progression

Ophthalmic herpes zoster

Oral herpes

Pulmonary embolism

Septic shock

Pneumonia influenzal

Myopathy

Steroid diabetes

Pseudomonal sepsis

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Itacitinib Plus Corticosteroids

Placebo 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

~960

Osimertinib

2017

Completed Phase 4

~1100

0 / 5Eligibility criteria met

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.