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Tyrosine Kinase Inhibitor
Osimertinib for Early-Stage Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Collin Blakely, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented activating EGFR mutation on tumor samples by CLIA-approved test
Hemoglobin >= 9 g/dL with no blood transfusions in the 28 days prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing osimertinib to treat early-stage lung cancer. Osimertinib may stop the growth of cancer cells by blocking a protein called EGFR that is found in cancer cells.
Who is the study for?
Adults over 18 with stage I-IIIA non-small cell lung cancer that has a specific EGFR mutation. They must be fit for surgery, have an ECOG Performance Status of 0-1, and meet certain blood test criteria. Excluded are those with advanced cancer stages, active second cancers, certain heart conditions, uncontrolled diseases or infections, pregnancy or breastfeeding women.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Osimertinib before surgery in patients with early-stage lung cancer that has a particular genetic change (EGFR mutation). The goal is to see if this drug can halt tumor growth by blocking the mutant proteins.See study design
What are the potential side effects?
Osimertinib may cause side effects like diarrhea, rash, dry skin, nail changes and mouth sores. More serious but less common side effects include lung problems (like shortness of breath), heart issues (like abnormal heartbeat), and eye problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor has an EGFR mutation confirmed by a certified test.
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My hemoglobin is at least 9 g/dL and I haven't had a blood transfusion in the last 28 days.
Select...
My kidney function is good, with a filtration rate over 50 mL/min.
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I am fully active or can carry out light work.
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A certified surgeon has approved me for lung cancer surgery.
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My PET-CT scan within the last 2 months shows stage I to IIIa lung cancer.
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My tumor is at least 1 cm big.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants With a Major Pathological Response (MPR)
Secondary outcome measures
Disease-free Survival Rate (DFS)
Mean Disease-free Survival (DFS)
Median Percentage Change in Tumor Burden (Depth of Response)
+6 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: Treatment (osimertinib)Experimental Treatment2 Interventions
Participants receive 80mg osimertinib orally, once a day (PO QD) on days 1-28. Treatment repeats every 28 days for a minimum of 1 cycle prior to surgery in the absence of disease progression or unacceptable toxicity. Investigators will have the option to give a second cycle of study drug prior to surgery if clinically indicated. Depending on the timing of the final scans, patients may ultimately receive up to two weeks additional therapy with study drug beyond end of cycle 1 (or cycle 2) while awaiting surgery. Patients then undergo surgical resection of their cancer. No treatment with the study drug will be given after surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,503 Previous Clinical Trials
15,236,628 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,875 Total Patients Enrolled
Collin Blakely, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
35 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer, but it's completely treated.I don't have severe side effects from previous treatments.My hemoglobin is at least 9 g/dL and I haven't had a blood transfusion in the last 28 days.My kidney function is good, with a filtration rate over 50 mL/min.I can take pills by mouth.Your bilirubin levels are normal, unless you have Gilbert's syndrome.I have heart issues like heart failure, artery disease, or low heart pump function.You have unmanaged health, emotional, family, social, or location-related issues.I am not pregnant or breastfeeding.My tumor has an EGFR mutation confirmed by a certified test.Your white blood cell count is more than 3,000 per microliter.I have a history of lung scarring or inflammation not caused by an infection.My cancer is at stage IIIB or has spread to distant areas.I haven't taken antibiotics for treatment in the last 2 weeks.I have a digestive system condition that affects how my body absorbs food.I haven't taken any prohibited medications in the last 14 days.I have heart problems that are not being treated or controlled.I've been treated with an EGFR inhibitor for less than 28 days without major side effects.My cancer has spread to the brain or spinal cord.I am not on medications that affect heart rhythm or strongly change drug breakdown.I am fully active or can carry out light work.A certified surgeon has approved me for lung cancer surgery.My lung cancer diagnosis was confirmed with a biopsy in the last 3 months.You have had a bad reaction to osimertinib or similar medications in the past.Your white blood cell count is lower than 1,500 per microliter.You have tested positive for HIV in a blood test.You have a platelet count higher than 100,000 per microliter.I have a history of heart problems.I do not have severe diseases, active infections, or tuberculosis.I am 18 years old or older.My PET-CT scan within the last 2 months shows stage I to IIIa lung cancer.You had a brain scan in the last 60 days that did not show signs of cancer spread.My tumor is at least 1 cm big.Your potassium and magnesium levels are normal.Your AST and ALT levels should be no more than 2.5 times the upper limit of normal.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
What are the possible risks associated with Osimertinib use?
"The safety of Osimertinib is estimated to be a 2 on the scale, as only limited data exists that confirms its efficacy and more research needs to be conducted."
Answered by AI
What is the participant capacity of this clinical trial?
"Unfortunately, there are no more spots available in this clinical trial. It was initially posted on July 31st 2018 and last updated on October 13th 2022. However, 1908 trials for non-small cell lung carcinoma and 101 studies pertaining to Osimertinib are still recruiting individuals at the current time."
Answered by AI
What is the breadth of facilities that are presently conducting this trial?
"Currently, 4 sites are facilitating this clinical trial. These locations span from Davis to San Francisco and Aurora with a few other centres in between; it is advisable for potential participants to choose the closest site available so as to limit their required travel distance."
Answered by AI
Are investigators currently enrolling volunteers into this experiment?
"As per the clinicaltrials.gov listing, this medical study is no longer recruiting patients - having been initially posted on July 31st 2018 and last updated October 13th 2022. However, there are an additional 2,009 other trials that currently require participants."
Answered by AI
Is this research pioneering in its field?
"Since 2013, AstraZeneca has sponsored a series of clinical trials to study Osimertinib, with the first trial involving 603 patients. This drug received Phase 1 and 2 approval following those initial experiments and today 101 studies are running across 1059 cities in 51 countries."
Answered by AI
Has Osimertinib been investigated for other purposes in the past?
"Since 2013, Osimertinib has been studied at Research Site with 63 completed trials and 101 active ones. Of the ongoing studies, many are located in Davis, California."
Answered by AI
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