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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 If patients experience disease progression during the treatment period, they will be withdrawn from the study.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Aumolertinib | Experimental | Single Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aumolertinib | Drug | Aumolertinib treatment (110mg, p.o., QD) for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective Response Rate) | ORR (Objective Response Rate) is defined as the proportion of participants who confirmed at least one CR (Complete Response) or PR (Partial response) before disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST)1.1 as assessed by the investigator. | 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| pCR (Pathological Complete Response) | pCR (Pathological Complete Response) is defined as the proportion of patients in whom no tumor cells are found in all pathological samples after surgical resection following neoadjuvant treatment. | 3 months. |
| MPR (Major Pathological Response) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in EGFR mutation prediction value. | This analysis observes the changes in the EGFR mutation prediction value of the target lesion diagnosed by AI before and after receiving neoadjuvant treatment with Aumolertinib. | 3 months. |
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:
Female of childbearing potential must use appropriate contraceptive measures during the study and should not be breastfeeding for at least 3 months after discontinuation of study treatment. Before initiation of treatment, a negative pregnancy test is required, or one of the following criteria should be met to demonstrate no risk of pregnancy:
Male patients should use barrier contraception (i.e., condoms) from enrollment until 3 months after discontinuation of study treatment.
Voluntary participation of the subject and signed informed consent.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
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:
Insufficient bone marrow reserve or organ function, as indicated by the following laboratory values:
Women who are either pregnant or breast-feeding.
History of hypersensitivity reactions to any active or inactive components of Aumolertinib or drugs with chemical structures similar to Aumolertinib or in the same class.
Patients who may have poor compliance with the study procedures and requirements in the investigator's judgment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhua Liang, M.D | Contact | +86-13710249454 | liangwh1987@163.com | |
| Jianxing He, M.D | Contact | +86-20-83337792 | drjianxing.he@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianxing He, M.D | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
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MPR (Major Pathological Response) is defined as the presence of residual tumor of less than 10% on pathological assessment after neoadjuvant treatment-induced tumor regression. |
| 3 months. |
| PFS (Progression-Free Survival) | PFS (Progression-Free Survival) is defined as the time from the first dose of study intervention until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from therapy or receives another anti-cancer therapy prior to progression. | 1 year. |
| OS (Overall Survival) | OS (Overall Survival) is defined as the time from the initial administration of treatment to the date of death due to any cause. Patients who have not died at the time of statistical analysis will have their survival time censored at the last known date of their survival. | 1 year. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |