← Back to Search

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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
My diagnosis is non-small cell lung cancer.
Select...
My cancer is advanced and cannot be treated with a combination of therapies.
Select...
I agree to use effective birth control during and for 3 months after the study.
Select...
I have been screened for hepatitis B and C, and if positive, I am willing to follow antiviral treatment as required.
Select...
My cancer has a specific change in the EGFR gene.
Select...
I have not used EGFR TKI for my advanced cancer, or only used it for less than 3 months if I'm in the initial safety group.
Select...
I've had only one prior treatment for my cancer and have recovered from its side effects.
Select...
I can get insurance coverage or afford to pay for gefitinib.
Select...
My organs and bone marrow are functioning normally.
Select...
I can take care of myself but might not be able to do active work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival at 9 months
Secondary outcome measures
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)

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,824 Total Patients Enrolled
NovartisIndustry Sponsor
1,607 Previous Clinical Trials
2,709,780 Total Patients Enrolled
Zofia Piotrowska, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, North Shore Cancer Center
Yale University School Of Medicine (Medical School)

Media Library

Lung Cancer Clinical Trial 2023: EGF816 Highlights & Side Effects. Trial Name: NCT03292133 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the regulatory status of Gefitinib?

"The safety rating of Gefitinib is a 2 since this trial, which assesses its efficacy, is only in the second phase. Nevertheless, there have been some studies verifying its security."

Answered by AI

Is there space in this trial for more participants?

"Per the information on clinicaltrials.gov, this research endeavour is currently not recruiting participants. Initially posted in October 2017 and last updated in January 2022, there are presently no vacancies for this study; however, 1656 other medical investigations remain open to enrolment at this time."

Answered by AI

What is the capacity of participants for this investigation?

"Unfortunately, this clinical trial is not presently accepting enrollees. It was initially advertised on October 31st 2017 and edited as recently as January 21st 2022. Alternatively, researchers are currently recruiting 1628 participants to test treatments for lung cancer and 28 people for Gefitinib studies."

Answered by AI

Have there been previous experiments with Gefitinib to assess its efficacy?

"At the moment, there are 28 ongoing studies assessing Gefitinib. Of these trials, 10 have reached Phase 3 and most of them are based in Chuo-Ku, Tokyo. However, a total of 539 sites across the world are conducting research related to this medication."

Answered by AI
~1 spots leftby Mar 2025