Recruiting

Testing two new medications together for a specific lung cancer type

Plain-English translation of NCT06816992 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated September 2026 · How we translate trials

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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 whether ORIC-114, a new oral medication, works better when combined with amivantamab (a medication given by injection) to treat advanced lung cancer patients who have a specific genetic change called an EGFR exon 20 insertion mutation. The study aims to find the right dose of this medication combination and see how well it shrinks tumors while monitoring for side effects.

This specific type of lung cancer is hard to treat with standard therapies, and patients need new options. This study explores whether combining two medications that target this genetic mutation differently might provide better results than using them alone.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced lung cancer that has spread, with a confirmed EGFR exon 20 insertion mutation
you have measurable disease that can be tracked on scans
you are in good enough overall health (ECOG performance status 0 or 1)
your organs are functioning adequately for treatment
you are willing to have a tumor biopsy before starting treatment
you have brain metastases that are not causing symptoms (optional eligibility)

You likely don't qualify if…

you have leptomeningeal disease or untreated spinal cord compression
you have a history of interstitial lung disease or active lung inflammation
you have active stomach or bowel disease that would prevent you from absorbing oral medication
you have received prior immunotherapy
your lung cancer has transformed into small cell lung cancer

What participation looks like

You will take ORIC-114 as a daily oral pill and receive amivantamab injections on a regular schedule. The first part of the study will test different dose levels to find the safest and most effective combination, while the second part will enroll more patients at the chosen dose. You'll have regular clinic visits for blood tests, scans to measure your tumor, and check-ins about any side effects you're experiencing.

AI-generated summary from trial data · Sep 5, 2026 · Not medical advice

Trial locations(4 sites)

United States

NYU Langone Health, New York, New York

Virginia Cancer Specialists, Fairfax, Virginia

Australia

Peter MacCallum Cancer Centre, Melbourne, Victoria

Canada

The Princess Margaret Hospital, Toronto, Ontario