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Tyrosine Kinase Inhibitor
Osimertinib + Gefitinib for Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Pasi 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
Participants must be aged ≥ 18 years
Participants must have histologically confirmed stage IV NSCLC with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is studying a combination of two drugs to see if it can effectively treat NSCLC that has an EGFR mutation.
Who is the study for?
Adults over 18 with advanced Non-Small Cell Lung Cancer and specific EGFR mutations, who haven't had prior treatments for lung cancer or recent major surgery. They must not be pregnant, agree to use contraception, have a life expectancy over 12 weeks, and good organ function. Those with unstable health conditions or taking certain drugs are excluded.Check my eligibility
What is being tested?
The trial is testing Osimertinib (Tagrisso) combined with Gefitinib (Iressa) as a treatment for NSCLC patients who have never received EGFR inhibitors before. It aims to see if this drug combo can effectively treat the cancer.See study design
What are the potential side effects?
Possible side effects include diarrhea, rash, dry skin, decreased appetite, nail toxicity, fatigue; less commonly interstitial lung disease/pneumonitis may occur which could cause difficulty breathing or cough.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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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I am not pregnant or breastfeeding.
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My organ and bone marrow functions are normal.
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I have never received EGFR therapy, chemotherapy, or immunotherapy.
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
Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles
Secondary outcome measures
Objective response rate
Overall Survival
Progression free survival
+1 moreSide effects data
From 2015 Phase 3 trial • 219 Patients • NCT0140426013%
Leukopenia
8%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A
Arm B
Trial Design
1Treatment groups
Experimental Treatment
Group I: Gefitinib + OsimertinibExperimental Treatment2 Interventions
Gerfitinib will administered orally at a pre determine dose daily
Osimertinib will administered orally at a pre determine dose daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Gefitinib
2005
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,854 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,900 Total Patients Enrolled
Pasi Janne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any chemotherapy or experimental drugs for my advanced lung cancer.I am not taking any strong CYP3A4 inhibitors.I have been treated with drugs targeting EGFR or similar proteins.I do not have any major health issues that are not under control.I currently have a bleeding disorder.I do not have an active infection or need ongoing antiviral medication for hepatitis B, C, or HIV.You must have a disease that can be measured using specific criteria.I am 18 years old or older.I have not had radiotherapy in the last 2 weeks.I do not have uncontrolled brain or spinal cord issues.I don't have severe side effects from previous treatments.I haven't had any cancer in the past 3 years, except for skin cancer that was treated.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.My biopsy tissue from diagnosis is available for advanced genetic testing.It has been over 4 weeks since my last major surgery.I am a male willing to use contraception during and for 3 months after treatment.I agree to use birth control during and for 3 months after the study drug treatment.I am not pregnant or breastfeeding.I have issues that affect my ability to swallow or absorb pills.I am currently taking warfarin.My cancer has the EGFR T790M mutation.My organ and bone marrow functions are normal.You have had allergic reactions to drugs similar to gefitinib or osimertinib.It has been over 2 weeks since my last radiation treatment.I have never received EGFR therapy, chemotherapy, or immunotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Gefitinib + 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 is the uppermost limit for enrollees in this medical experiment?
"At this time, there is no ongoing recruitment for this trial. Initially posted on May 9th 2017 and last updated on October 17th 2022, the study has concluded its patient search. If one wishes to explore other studies related to carcinoma non-small cell lung or Gefitinib, 2041 and 122 trials respectively are actively recruiting participants."
Answered by AI
Is there an ongoing opportunity for patient enrollment in this research?
"Unfortunately, this trial is not presently enrolling. Originally posted on May 9th 2017 and most recently updated on October 17th 2022, if you are seeking alternative studies there are currently 2041 trials looking for patients with carcinoma non-small cell lung cancer and 122 research projects recruiting participants for Gefitinib treatments."
Answered by AI
Are there other scholarly investigations utilizing Gefitinib?
"At the moment, 122 distinct clinical trials are in progress for Gefitinib. 26 of those reside at Phase 3 and originate from Uniondale, New york; however, across the world there are 5019 medical sites running tests for this medication."
Answered by AI
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