OncoMatch/Clinical Trials/NCT05686434
Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
Is NCT05686434 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Osimertinib for nsclc, stage i.
Treatment: Osimertinib — This is a prospective, open, single-center, single-arm phase II clinical study with common EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory.To evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
the tumor contains one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or in conjunction with other EGFR mutations, including T790M
Required: EGFR L858R
the tumor contains one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), alone or in conjunction with other EGFR mutations, including T790M
Disease stage
Required: Stage I
Performance status
WHO 0–1
Prior therapy
Cannot have received: antitumor therapy
Exposure to other antitumor therapies before enrollment
Lab requirements
Blood counts
absolute neutrophil count <1.5×10⁹/L; Platelet count <100×10⁹/L; Hemoglobin <90 g/L
Kidney function
Serum creatinine >1.5 ULN with creatinine clearance <50 mL/min [as measured or calculated by Cockcroft and Gault formulas] - creatinine clearance only needs to be confirmed when creatinine >1.5 ULN
Liver function
Alanine aminotransferase > 2.5 ULN; Aspartate aminotransferase >2.5 times ULN; Total bilirubin > 1.5 ULN
Cardiac function
QTc > 470 ms from 3 ECGs; clinically significant ECG abnormalities (e.g., left bundle branch block, third degree heart block, second degree heart block); factors increasing risk of prolonged QTc or arrhythmia (heart failure, hypokalemia, congenital long QT syndrome, sudden unexplained death under 40 years of age in a first-degree relative, or any concomitant medication known to prolong the QT interval)
Lack of adequate bone marrow reserve or organ function (demonstrated by any of the following laboratory values: absolute neutrophil count <1.5×10⁹/L; Platelet count <100×10⁹/L; Hemoglobin <90 g/L; Alanine aminotransferase > 2.5 ULN; Aspartate aminotransferase >2.5 times ULN; Total bilirubin > 1.5 ULN; Serum creatinine >1.5 ULN with creatinine clearance <50 mL/min [as measured or calculated by Cockcroft and Gault formulas] - creatinine clearance only needs to be confirmed when creatinine >1.5 ULN); Any of the following cardiac criteria: QTc > 470 ms from 3 ECGs; clinically significant ECG abnormalities; factors increasing risk of prolonged QTc or arrhythmia
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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