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Experimental lung cancer drug trial halted early

NCT ID NCT06186076

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug called TRX-221 in people with a specific type of advanced lung cancer (EGFR mutant NSCLC) that had stopped responding to standard treatments. The goal was to see if the drug was safe and could shrink tumors. The trial was stopped early, and only 19 people took part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

19 people

The number who actually took part.

Started

Jun 2024

Finished

Dec 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with ECOG performance status score of 0 or 1 2. Histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic NSCLC harboring an activating EGFR mutation 3. Failed standard of care treatments progressed after anti tumor treatments including at least 1 approved EGFR TKI \[Phase2: TKIs should include the approved EGFR TKIs with activity against T790M (e.g., osimertinib)\] 4. Slots may be reserved for patients with certain resistant mutations (i.e., EGFR C797X mutation with or without T790M mutation as required by the sponsor) \[Phase 1\] 5. EGFR C797X mutation with or without T790M mutation \[Phase 2\] 6. Not received more than 1 prior line of platinum based chemotherapy in the metastatic setting \[Phase 2\] 7. Having at least 1 measurable tumor lesion per RECIST v1.1 criteria \[Phase 2\] 8. Having adequate bone marrow, hepatic, and renal function as specified in the protocol Exclusion Criteria: 1. NSCLC with mixed cell histology or a tumor with histologic transformation of small cell elements 2. Patients having tumor with any additional known driver of alterations 3. Patients with presence of another active primary malignant tumor that has been diagnosed or required therapy within 2 years prior to the initiation of the study treatment 4. Patients who have unstable and symptomatic primary CNS tumors/metastasis, leptomeningeal metastases or spinal cord compression which are not suitable for enrollment, as judged by the Investigator 5. Patients having clinically active ongoing ILD of any etiology 6. Clinically significant cardiac conditions, infections, refractory GI diseases as specified in the protocol 7. Patients having any unresolved toxicities from prior anti tumor therapy and surgery greater than CTCAE Grade 1 at the time of starting the study treatment 8. Recent anticancer therapy: EGFR-TKI, Immunotherapy or any other systemic anticancer therapy or radiotherapy (specific duration prior to starting study medication per protocol)

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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

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Chungbuk National University Hospital

    Chungju, North Chungcheong, 28644, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam, Kyeongki, 13620, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • The Catholic University of Korea St. Vincent Hospital

    Suwon, Kyeongki, 16247, South Korea

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