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.
Treatment: TRX-221 — This 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).
Check if I qualifyExtracted 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
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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