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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mechanisms of resistance to Osimertinib
Secondary outcome measures
Best objective response
Overall Response Rate
Overall survival
+1 moreSide effects data
From 2020 Phase 4 trial • 60 Patients • NCT0385355110%
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
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
~1010
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,950 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,271 Previous Clinical Trials
288,612,829 Total Patients Enrolled
Pasi A Jänne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
844 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any radiation therapy, including for the brain, in the last 2 weeks.I am a male willing to use contraception during the trial and for 4 months after, and will not donate sperm during this time.I do not have serious heart issues, lung disease, bleeding disorders, severe infections, or specific genetic mutations.I have a tissue sample from my diagnosis available for testing, or I've already had NGS testing before starting osimertinib.I am not pregnant or breastfeeding and agree to use contraception during and after the study.I have a tumor that can be measured with imaging or physical exam.I am 18 years old or older.My blood counts and liver/kidney functions are within normal ranges.I have biopsy tissue from my diagnosis that can be used for advanced genetic testing.I have not been treated with EGFR or ERBB family targeted therapies, except possibly osimertinib in the first 3 months.I have not taken any drugs for metastatic NSCLC.I started osimertinib treatment less than 3 months ago and my cancer hasn't worsened.I have brain or spinal cord issues but am stable and haven't needed steroids for 2 weeks.I haven't had cancer in the last 3 years, except for certain skin cancers.I am fully active or can carry out light work.You have had allergic reactions to drugs similar to osimertinib in the past.My lung cancer is stage IV with specific EGFR mutations.My stage IV cancer has returned but I meet the prior treatment criteria.I have severe, ongoing nausea or issues with my digestive system that affect my ability to take pills.I am not pregnant, breastfeeding, and I use effective birth control.It has been over 2 weeks since I had any major surgery.I am willing to have more than one tumor biopsy if it's safe.I don't have severe side effects from previous treatments.I am taking and can't stop medications or supplements that strongly affect liver enzymes.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
Can you provide an assessment of the potential risks related to Osimertinib treatment?
"According to our assessment, the safety of Osimertinib is rated at 2 due to evidence from Phase 2 trials that suggest some safety but lack data regarding efficacy."
Answered by AI
How many participants are taking part in the clinical investigation?
"Affirmative. Data from clinicaltrials.gov shows that this medical experiment, initially published on August 13th 2018, is actively selecting patients. The project seeks to enlist 30 test subjects over two respective sites."
Answered by AI
Has Osimertinib been evaluated in any other research studies previously?
"Currently, 101 clinical trials for Osimertinib are underway with 17 of them in the third phase. Most studies originate from Uniondale, NY but there are 4699 sites conducting research on this medication globally."
Answered by AI
Is this an unprecedented medical experiment?
"As of now, there are 101 active Osimertinib trials occurring in cities and nations throughout the globe. The first research study for this medication was sponsored by AstraZeneca and initiated back in 2013 with a sample size of 603 patients; reaching Phase 1 & 2 approval stages. Since then, 30 more studies have been conducted."
Answered by AI
Is the trial currently opening its doors to new participants?
"Correct. Clinicaltrials.gov confirms that this study, posted on August 13th 2018, is currently searching for 30 volunteers across 2 sites."
Answered by AI
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