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Tyrosine Kinase Inhibitor

Osimertinib for Lung Cancer

Phase 2
Recruiting
Led By Pasi A Jänne, MD, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients must be willing to use adequate contraception at least 2 weeks before receiving any study medication, while on treatment with study drug, and for 6 weeks after finishing treatment. Female patients must not be pregnant or breastfeeding
Participants must have measurable disease at baseline, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam
Must not have
Significant medical history or unstable medical comorbidities, including heart disease, clinically important abnormalities in rhythm, conduction or morphology of resting ECG, factors that increase the risk of QTc prolongation or risk of arrhythmic events, past medical history of interstitial lung disease, active bleeding diatheses, known active infection or ongoing antiviral medication for viral infections, cardiac ejection fraction of < 45%, evidence of severe or uncontrolled systemic diseases, known to be T790M+ (on pre-treatment tumor or plasma) or known germline T790M
Any cytotoxic chemotherapy, investigational agents, immunotherapy or anticancer drugs for the treatment of metastatic NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a targeted therapy against lung cancer.

Who is the study for?
Adults with stage IV Non-Small Cell Lung Cancer (NSCLC) and specific EGFR mutations can join this trial. They must have good organ function, not be pregnant or breastfeeding, use contraception, and agree to biopsies. Excluded are those who've had certain cancer treatments or uncontrolled brain metastases.
What is being tested?
The trial is testing Osimertinib (Tagrisso), a targeted therapy for NSCLC with an EGFR mutation. Participants will take the drug and may have started treatment within three months before joining the study if they meet all criteria.
What are the potential side effects?
Osimertinib may cause diarrhea, rash, dry skin, nail changes, mouth sores, reduced appetite, coughing up blood; heart rhythm problems; eye inflammation; low white blood cell count increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or breastfeeding and agree to use contraception during and after the study.
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I have a tumor that can be measured with imaging or physical exam.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My lung cancer is stage IV with specific EGFR mutations.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart issues, lung disease, bleeding disorders, severe infections, or specific genetic mutations.
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I have not taken any drugs for metastatic NSCLC.
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I have severe, ongoing nausea or issues with my digestive system that affect my ability to take pills.
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I am not pregnant, breastfeeding, and I use effective birth control.
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I don't have severe side effects from previous treatments.
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I am taking and can't stop medications or supplements that strongly affect liver enzymes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
Mechanisms of resistance to Osimertinib
Secondary study objectives
Best objective response
Overall Response Rate
Overall survival
+1 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
Blood creatine phosphokinase increased
10%
Fatigue
8%
Decreased appetite
8%
Diarrhoea
8%
Cough
7%
Mucosal inflammation
7%
Rash
7%
Pain in extremity
7%
Constipation
7%
Thrombocytopenia
7%
Paronychia
3%
Dyspnoea
2%
Dengue fever
2%
Disease progression
2%
Cardio-respiratory arrest
2%
Cataract
2%
Mouth Ulceration
2%
Deep Vein Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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: OsimertinibExperimental Treatment1 Intervention
Osimertinib: Oral, once a day, dosage determined per protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,207 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,400 Previous Clinical Trials
289,122,702 Total Patients Enrolled
Pasi A Jänne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
844 Total Patients Enrolled

Media Library

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03586453 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Osimertinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03586453 — Phase 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03586453 — Phase 2
~1 spots leftby Feb 2025
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