Experimental lung cancer drug trial halted early – only 18 patients enrolled
NCT ID NCT05765734
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a new drug, TAS3351, in 18 people with advanced lung cancer that had a specific genetic change (EGFR mutation). The main goals were to check safety and see if the drug could shrink tumors. The study was stopped early, so results are limited.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
18 people
The number who actually took part.
- Started
-
May 2023
- Finished
-
Mar 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Locally advanced, non-resectable or metastatic NSCLC * Have adequate organ function * Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Has tumor tissue available to allow for analysis of EGFRmt status Dose Escalation: • Has any EGFRmt status Dose Escalation back-fill part, Dose Expansion and Phase II: * Has any sensitizing EGFRmt and a confirmed C797S EGFRmt * Has measurable disease per response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1) Exclusion Criteria: * Participating in medical research not compatible with this study * Symptomatic and unstable central nervous system (CNS) metastases * Have not recovered from prior cancer treatment * Have a significant cardiac condition * Are a pregnant or breastfeeding female * A serious illness or medical condition * Unable to swallow or digest pills
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institut Gustave Roussy
Villejuif, Val De Marne, 94805, France
-
Leiden University Medical Center (LUMC)
Leiden, 2333ZA, Netherlands
-
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577, Japan
-
Next Oncology - Virginia
Fairfax, Virginia, 22031, United States
-
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777, Japan
-
Tennessee Oncology
Nashville, Tennessee, 37203, United States
-
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937, Germany
-
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer