Testing a new daily pill for advanced lung cancer with specific genetic mutations

Plain-English translation of NCT06905197 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new medication called , which is a daily pill designed to treat advanced lung cancer in patients whose tumors have specific genetic mutations called EGFR mutations. The study is divided into two parts: first, researchers will test different doses to find the safest and most effective amount, and then they will enroll more patients at the doses that work best. Doctors want to understand how well this medication works and what side effects patients might experience.

Some patients with lung cancer develop resistance to existing EGFR treatments, meaning their current medications stop working. This trial is exploring whether this new medication can help patients whose cancer has progressed despite prior treatments, or offer a better option for patients who haven't been treated yet.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with advanced non-small cell lung cancer with specific EGFR genetic mutations (called sensitizing mutations)
you have progressed on at least one prior EGFR targeted therapy (or you have never been treated with these drugs, depending on which part of the study enrolls you)
you are able to provide tumor tissue samples collected after your cancer progressed or before starting this study
you have an expected life span of at least 12 weeks and are in good enough health to participate (ECOG score of 0 or 1)
you can provide written informed consent to participate

You likely don't qualify if…

you have certain uncommon EGFR mutations (including exon 20 insertions or other specific types, depending on which part of the study you might join)
you have received chemotherapy, immunotherapy, or other cancer drugs within the past 2 weeks
you have had major surgery within the past 4 weeks or are planning surgery during the study
you are currently taking certain medications that interfere with how your body processes drugs (such as strong CYP3A4 inhibitors or inducers, proton pump inhibitors, or certain narrow-window medications)
you have unresolved severe side effects from your previous cancer treatments

What participation looks like

You will take the medication by mouth once daily as a pill. The trial has two phases: in the first phase, small groups of patients will receive gradually increasing doses to find the safest level; in the second phase, more patients will receive the dose that was found to work best. You will have regular visits with your doctor to have blood tests, imaging scans, and check-ups to monitor how the treatment is working and any side effects you may experience. The study will track your health and how your cancer responds over time.

AI-generated summary from trial data · Jun 24, 2026 · Not medical advice

Trial locations(5 sites)

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York

Herbert Irving Comprehensive Cancer Center, New York, New York

Virginia Cancer Specialist (NEXT Oncology-Virginia), Fairfax, Virginia

Australia

Blacktown Hospital, Blacktown, New South Wales

Chris O'Brien Lifehouse, Camperdown, New South Wales