Experimental lung cancer drug trial halted early
NCT ID NCT06186076
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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19 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Dec 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 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
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Asan Medical Center
Seoul, 05505, South Korea
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Chungbuk National University Hospital
Chungju, North Chungcheong, 28644, South Korea
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Samsung Medical Center
Seoul, 06351, South Korea
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Seoul National University Bundang Hospital
Seongnam, Kyeongki, 13620, South Korea
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Severance Hospital
Seoul, 03722, South Korea
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The Catholic University of Korea St. Vincent Hospital
Suwon, Kyeongki, 16247, South Korea
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