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Tyrosine Kinase Inhibitor

EGF816 + Gefitinib for Lung Cancer

Phase 2

Waitlist Available

Led By Zofia Piotrowska, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years.

Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).

Must not have

Participants with clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention) and patients with history of clinically significant interstitial lung disease or radiation pneumonitis.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the combination of these drugs is more effective in treating EGFR mutation-positive lung cancer than either drug alone.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer that has specific EGFR mutations and no prior extensive treatment. They must have good organ function, agree to use effective contraception, and not be pregnant or breastfeeding. Prior chemotherapy is limited to one line in the metastatic setting.

What is being tested?

The study tests a combination of two drugs, EGF816 and Gefitinib, as potential treatments for lung cancer with certain genetic changes (EGFR mutation-positive). It aims to see how well these drugs work together in patients who haven't tried similar therapies before.

What are the potential side effects?

Possible side effects include reactions related to liver function changes, blood count variations, fatigue, digestive issues like nausea or diarrhea. There may also be risks during pregnancy; hence contraception is required.

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 diagnosis is non-small cell lung cancer.

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My cancer is advanced and cannot be treated with a combination of therapies.

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I can get insurance coverage or afford to pay for gefitinib.

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I can take care of myself but might not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active or symptomatic lung conditions that affect my daily activities.

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I do not have any severe illnesses that could interfere with the study.

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I have had a bone marrow or organ transplant.

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I do not have uncontrolled heart problems.

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I cannot or do not want to swallow pills.

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I am not taking strong CYP3A4 inhibitors or inducers.

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I am allergic to medications similar to EGF816 or gefitinib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Progression Free Survival at 9 months

Secondary study objectives

Overall Survival

Response Rate

Safety and Tolerability of the EGF816/gefitinib combination (Summary of the adverse events experienced by study participants as evaluated by CTCAE v4)

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: EGF816 + GefitinibExperimental Treatment2 Interventions

* All patients will receive gefitinib orally once daily * EGF816 will be administered orally once daily * Participant will be requested to maintain a medication diary of each dose of medication

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gefitinib

2005

Completed Phase 3

~2440

EGF816

2014

Completed Phase 2

~530