OncoMatch/Clinical Trials/NCT07375316
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positive ctDNA After lead-in Osimertinib Monotherapy
Is NCT07375316 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Targeted therapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Presence of sensitizing EGFR mutation (exon 19 deletion and/or L858R)
Required: EGFR l858r
Presence of sensitizing EGFR mutation (exon 19 deletion and/or 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 locally advanced or metastatic NSCLC
Completion of 3~5-week first-line treatment with osimertinib monotherapy. Non-PD as assessed by investigator per RECIST v1.1
Cannot have received: systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than 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-targeted therapy
Prior treatment with 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 formula)
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]; NYHA Class III or IV heart failure [excluded]
Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony stimulating factor therapy within 2 weeks prior to the first dose), defined as follows: Hematology: neutrophil count (NEUT) ≥ 1.5×109/L; platelet (PLT) ≥ 100×109/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 formula); Coagulation function: INR, APTT and PT ≤ 1.5× ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07375316 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC other than osimertinib, TROP2-targeted therapy, topoisomerase I-targeted therapy disqualifies patients from enrollment.
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 IIIB or IIIC or IV 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.
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