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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
Must not have
Any cytotoxic chemotherapy, investigational agents, or anticancer drugs for the treatment of metastatic NSCLC
Patients currently receiving medications or herbal supplements known to be potent inhibitors of CYP3A4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any chemotherapy or experimental drugs for my advanced lung cancer.
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I am not taking any strong CYP3A4 inhibitors.
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I have been treated with drugs targeting EGFR or similar proteins.
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I currently have a bleeding disorder.
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I do not have an active infection or need ongoing antiviral medication for hepatitis B, C, or HIV.
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I have not had radiotherapy in the last 2 weeks.
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I do not have uncontrolled brain or spinal cord issues.
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I don't have severe side effects from previous treatments.
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I have issues that affect my ability to swallow or absorb pills.
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I am currently taking warfarin.
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My cancer has the EGFR T790M mutation.

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
Number of patients completing combination therapy with gefitinib and osimertinib for 6 x 28 day cycles
Secondary study objectives
Objective response rate
Overall Survival
Progression free survival
+1 more

Side effects data

From 2015 Phase 3 trial • 219 Patients • NCT01404260
13%
Leukopenia
8%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A
Arm B

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: 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
~1120
Gefitinib
2005
Completed Phase 3
~2440

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,427 Previous Clinical Trials
289,164,563 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,113 Previous Clinical Trials
358,833 Total Patients Enrolled
Pasi Janne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Gefitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03122717 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Gefitinib + Osimertinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Gefitinib Highlights & Side Effects. Trial Name: NCT03122717 — Phase 1 & 2
Gefitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03122717 — Phase 1 & 2
~2 spots leftby Apr 2025
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