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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
Must not have
History of allergic reactions attributed to compounds, or any of its excipients, of similar chemical or biologic composition to osimertinib or selumetinib
Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to medications similar to osimertinib or selumetinib.
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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 have had lung conditions that needed steroid treatment.
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I have been treated with drugs targeting EGFR or ERBB for my cancer.
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I do not have uncontrolled brain or spinal cord disease.
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I am taking and cannot stop medications that strongly affect CYP3A4 enzyme activity.
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I do not have active bleeding, infections, or am on antiviral meds for hepatitis B/C or HIV.
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I have not taken any chemotherapy or experimental drugs for advanced lung cancer.
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My cancer has a specific mutation known as T790M.
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I do not have serious heart problems or other unstable health issues.
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I am not using effective birth control, or I am pregnant or breastfeeding.
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I am taking high doses of vitamin E and cannot stop.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Best Objective Response
Secondary study objectives
Overall Survival
Progression Free Survival
Tolerability Proportion
+1 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
10%
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

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: 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
~2080
Osimertinib
2017
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,108 Previous Clinical Trials
357,212 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
120 Previous Clinical Trials
7,997 Total Patients Enrolled
Pasi A Janne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
756 Total Patients Enrolled

Media Library

Osimertinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03392246 — Phase 2
Lung Cancer Research Study Groups: Osimertinib + Selumetinib
Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT03392246 — Phase 2
Osimertinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03392246 — Phase 2
~2 spots leftby Jun 2025
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