OncoMatch/Clinical Trials/NCT07375316
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positvie ctDNA After lead-in Osimertinib Monotherapy
Is NCT07375316 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Osimertinib + Sacituzumab Tirumotecan and Osimertinib for non small cell lung cancer.
Treatment: Osimertinib + Sacituzumab Tirumotecan · Osimertinib — EGFR-mutated advanced NSCLC patients without ctDNA clearance after lead-in osimertinib monotherapy have inferior PFS compared with those with ctDNA clearance. Consequently, these patients might need an intensified therapeutic strategy, such as osimertinib combined with chemotherapy or ADC. This study aims to explore the efficacy and safety of osimertinib in combination with sacituzumab tirumotecan adaptively in EGFR-mutated advanced NSCLC patients with positive ctDNA after lead-in osimertinib monotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor (osimertinib) — first-line
Completion of 3-week first-line treatment with osimertinib monotherapy. Non-PD as assessed by investigator per RECIST v1.1
Cannot have received: systemic anti-tumor therapy
Exception: osimertinib
Prior treatment with systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than osimertinib
Cannot have received: TROP2-targeted therapy
Prior treatment with any TROP2-targeted therapy
Cannot have received: topoisomerase I inhibitor
any therapy that targets topoisomerase I (including ADCs)
Lab requirements
Blood counts
neutrophil count (NEUT) ≥ 1.5×10^9/L; platelet (PLT) ≥ 100×10^9/L; hemoglobin(Hb) ≥ 90g/L
Kidney function
serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
AST and ALT ≤ 2.5× ULN (if liver metastases are present, ≤5 × ULN); total bilirubin (TBIL) ≤ 1.5×ULN (if liver metastases are present, ≤3 × ULN); serum albumin ≥30g/L
Cardiac function
Mean corrected QT interval (QTcF) > 470 ms [excluded]; no recent MI, unstable angina, heart failure (NYHA III/IV), serious arrhythmia, or other serious cardiovascular/cerebrovascular disease within 6 months
Adequate organ and bone marrow function... Hematology: neutrophil count (NEUT) ≥ 1.5×10^9/L; platelet (PLT) ≥ 100×10^9/L; hemoglobin(Hb) ≥ 90g/L; Liver function: AST and ALT ≤ 2.5× ULN (if liver metastases are present, ≤5 × ULN); total bilirubin (TBIL) ≤ 1.5×ULN (if liver metastases are present, ≤3 × ULN); serum albumin ≥30g/L; Renal function: serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault); Coagulation function: INR, APTT and PT ≤ 1.5× ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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