EGF816 + Gefitinib for Lung Cancer

Overseen By Beth Kennedy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must be taking: Antivirals

Must not be taking: CYP3A4 inhibitors/inducers

Disqualifiers: Interstitial lung disease, Brain metastases, Uncontrolled cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 9 months

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying a combination of drugs as a possible treatment for EGFR mutation-positive lung cancer. The drugs involved in this study are: * EGF816 * Gefitinib

Research Team

Zofia Piotrowska, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

My diagnosis is non-small cell lung cancer.

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

Your platelet count is at least 100,000 per microliter.

Exclusion Criteria

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

I have not had lung radiation in the last 4 weeks or any radiation in the last week.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EGF816 and gefitinib orally once daily

9 months

Regular visits for monitoring and medication diary review

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• EGF816
• Gefitinib

Trial Overview 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.

Participant Groups

Group I: EGF816 + Gefitinib Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania