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Kinase Inhibitor
Osimertinib + Selumetinib for Lung Cancer
Phase 2
Waitlist Available
Led By Pasi A Janne, 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 not be pregnant or breast-feeding. Women of child-bearing potential must have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential by fulfilling specific criteria
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying how well the combination of these two drugs works in treating patients with NSCLC that has an EGFR mutation.
Who is the study for?
This trial is for adults with stage IV Non-Small Cell Lung Cancer (NSCLC) who have specific EGFR mutations and are new to treatment. They must be in good physical condition, not pregnant or breastfeeding, willing to use contraception, and have no history of severe allergic reactions to similar drugs. Prior cancer treatments should not include EGFR-targeted therapy or chemotherapy for metastatic disease.Check my eligibility
What is being tested?
The study tests a combination of Osimertinib (Tagrisso) and Selumetinib as potential treatments for NSCLC with an EGFR mutation. It aims to see how well these two targeted therapies work together compared to current standard care.See study design
What are the potential side effects?
Possible side effects may include heart issues, uncontrolled bleeding, infections like hepatitis B/C or HIV, lung problems such as interstitial lung disease, nausea/vomiting, difficulty swallowing/absorbing oral meds due to gastrointestinal conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant or breastfeeding and have confirmed this with a test or meet criteria proving I cannot become pregnant.
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I have at least one tumor that can be measured.
Select...
I am 18 years old or older.
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My stage IV lung cancer has a specific EGFR mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My organ and bone marrow functions are normal.
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I have not received any treatments targeting EGFR, chemotherapy, or immunotherapy for my metastatic disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best Objective Response
Secondary outcome measures
Overall Survival
Progression Free Survival
Tolerability Proportion
+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: Osimertinib + SelumetinibExperimental Treatment2 Interventions
Selumetinib are to be administered orally intermittently (4 days on, 3 days off)
Osimertinib are to be administered orally on a daily basis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2050
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,080 Previous Clinical Trials
341,208 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
116 Previous Clinical Trials
7,767 Total Patients Enrolled
Pasi A Janne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
756 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to medications similar to osimertinib or selumetinib.I don't have severe side effects from previous treatments.I haven't had any cancer except for certain skin cancers or cervical cancer in situ in the last 3 years.I have issues that affect my ability to swallow or absorb pills.I have had lung conditions that needed steroid treatment.I have been treated with drugs targeting EGFR or ERBB for my cancer.I have a tissue sample from my diagnosis available for advanced genetic testing.I am not pregnant or breastfeeding and have confirmed this with a test or meet criteria proving I cannot become pregnant.I had radiotherapy less than 2 weeks before starting the study treatment.Your heart's pumping ability is too low or you have a fast heart rate due to atrial fibrillation.You have certain eye conditions as listed.I do not have uncontrolled brain or spinal cord disease.I am taking and cannot stop medications that strongly affect CYP3A4 enzyme activity.I am willing to use contraception or abstain from sex during and for 3 months after treatment.I do not have active bleeding, infections, or am on antiviral meds for hepatitis B/C or HIV.I have at least one tumor that can be measured.I am 18 years old or older.It has been more than 2 weeks since my last major surgery.I have not taken any chemotherapy or experimental drugs for advanced lung cancer.My cancer has a specific mutation known as T790M.My stage IV lung cancer has a specific EGFR mutation.I am fully active or restricted in physically strenuous activity but can do light work.I will use effective birth control or abstain from sex during and for 3 months after the study.It has been over 2 weeks since my last radiation treatment.I do not have serious heart problems or other unstable health issues.I am not using effective birth control, or I am pregnant or breastfeeding.I am taking high doses of vitamin E and cannot stop.My organ and bone marrow functions are normal.I have not received any treatments targeting EGFR, chemotherapy, or immunotherapy for my metastatic disease.
Research Study Groups:
This trial has the following groups:- Group 1: Osimertinib + Selumetinib
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.
Has Osimertinib been cleared by the Federal Drug Administration?
"Osimertinib has received a Phase 2 rating, meaning that while there is data showing that it is safe, none of the trials have yet been able to confirm its efficacy."
Answered by AI
Is Osimertinib a common medication in clinical trials?
"Osimertinib is currently being trialled in 137 different medical studies, 22 of which are in Phase 3. The largest number of these trials are taking place in Uniondale, New york; however, there are 5683 clinical trial sites for Osimertinib around the world."
Answered by AI
Does this medical research break new ground?
"Osimertinib has a long clinical history, with the first study being sponsored by AstraZeneca all the way back in 2007. After this initial Phase 1 trial involving 58 patients, it received drug approval and 137 studies have been conducted in its wake across 1081 cities and 51 countries."
Answered by AI
Are there still opportunities to join this trial?
"No, this specific trial is not looking for more candidates at the moment. The original posting was on January 31st 2018 and the listing was last updated on August 1st 2022. There are however 2139 other trials that are currently recruiting patients."
Answered by AI
How many test subjects are currently enrolled in this trial?
"As of right now, this study is not taking on any more patients. The trial was originally posted on January 31st, 2018 and was last edited on August 1st, 2022. 2002 other trials involving carcinoma, non-small-cell lung are currently looking for participants and 137 trials for Osimertinib are actively enrolling patients."
Answered by AI
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