OncoMatch/Clinical Trials/NCT05686434
Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
Is NCT05686434 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
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.
Frequently asked questions
Is NCT05686434 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR exon 19 deletion is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR L858R is a required biomarker for enrollment.
What disease stage is eligible?
Stage I is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify