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OncoMatch/Clinical Trials/NCT06186076

A Study to Investigate Safety, Tolerability, PK and Anti-tumor Activity of TRX-221 in EGFRm NSCLC Patients

Is NCT06186076 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies TRX-221 for carcinoma, non-small-cell lung.

Phase 1/2RecruitingTherapex Co., LtdNCT06186076Data as of May 2026

Treatment: TRX-221This is a Phase 1/2, open-label study designed to investigate the safety, tolerability, PK, and anti-tumor activity of the study treatment in the treatment of patients with EGFR mutant NSCLC, who progressed following prior standard treatments which include the approved EGFR-TKIs with activity against T790M (e.g., osimertinib).

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR activating mutation

NSCLC harboring an activating EGFR mutation

Allowed: EGFR C797X mutation

EGFR C797X mutation with or without T790M mutation [Phase 1/2]

Allowed: EGFR T790M mutation

EGFR C797X mutation with or without T790M mutation [Phase 1/2]

Disease stage

Metastatic disease required

relapsed or refractory, locally unresectable advanced or metastatic NSCLC; Having at least 1 measurable tumor lesion per RECIST v1.1 criteria [Phase 2]

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: EGFR tyrosine kinase inhibitor

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)]

Cannot have received: platinum-based chemotherapy

Exception: not received more than 1 prior line in the metastatic setting [Phase 2]

Not received more than 1 prior line of platinum based chemotherapy in the metastatic setting [Phase 2]

Lab requirements

Blood counts

adequate bone marrow function as specified in the protocol

Kidney function

adequate renal function as specified in the protocol

Liver function

adequate hepatic function as specified in the protocol

Having adequate bone marrow, hepatic, and renal function as specified in the protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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