Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-gla… (NCT05946460) | Clinical Trial Compass
UnknownPhase 2
Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity.
China22 participantsStarted 2023-08-15
Plain-language summary
This is a prospective, single-center, single-arm, phase II study evaluating the efficacy and safety of neoadjuvant aumolertinib in previously untreated patients with AI-diagnosed EGFR-mutant and resectable pulmonary ground-glass opacity.
After informed consent signed, enrolled patients will undergo a treatment period and a follow-up period. During the treatment period, patients will receive aumolertinib treatment (110mg, p.o., QD) for 8 weeks. The surgery can be performed after a 1 to 2-week discontinuation period; if the patient does not consent to undergo surgery, follow-up can be conducted instead. If patients experience disease progression during the treatment period, they will be withdrawn from the study. During the follow-up period, the investigator will provide appropriate treatment recommendations based on the patient's condition and pathological results after surgical resection of the target lesion. Postoperative patients (or patients who completed the medication treatment and were followed up) will be monitored every six months for a duration of one year.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 18 years old (including 18) and 75 years old (including 75).
✓. No prior history of receiving anti-tumor treatment.
✓. Presence of at least one resectable malignant EGFR-mutant pulmonary ground-glass nodule diagnosed by AI (CTR ≤ 0.5, EGFR mutation prediction value ≥ 0.82), with a nodule diameter between 0.8-3cm (including both 0.8cm and 3cm).
✓. Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
✓. Adequate function of important organs, as follows:
. Diagnosis or treatment of any other malignant tumor within the past 5 years (excluding patients with previously resected basal cell carcinoma of the skin or other in situ cancers).
✕. Use of systemic anti-tumor treatment, including chemotherapy, radiotherapy, or targeted therapy (including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitors), before the study enrollment.
✕. Prediction of benign nodules or EGFR wild-type after AI tool assessment of the target lesion.
✕. Patient's organ system conditions:
✕. History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial lung disease.
✕. Evidence of interstitial lung disease detected on baseline CT scan.
✕. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or decompensated respiratory, cardiac, hepatic, or renal diseases) as evaluated by the investigator.
✕. Any unstable systemic disease (including active infection, Grade III hypertension, unstable angina, congestive heart failure, hepatic or renal disease, or metabolic disease).