Neoadjuvant Aumolertinib in Patients With AI-diagnosed EGFR-mutant High-risk Pulmonary Ground-glass Opacity.

NCT05946460 | Recruiting Phase 2

• 1 other identifier: CATO-2301
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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 If patients experience disease progression during the treatment period, they will be withdrawn from the study.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.

Conditions

Lung Cancer

Keywords

Aumolertinib; Neoadjuvant Treatment; AI-diagnosed; EGFR-mutant; Ground-glass Opacity

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• pCR (Pathological Complete Response)

  3 months.

• MPR (Major Pathological Response)

  3 months.

• PFS (Progression-Free Survival)

  1 year.

• OS (Overall Survival)

  1 year.

Other Outcomes (1)

• Changes in EGFR mutation prediction value.

  3 months.

Study Arms (1)

Neoadjuvant Aumolertinib

EXPERIMENTAL

Single Arm

Drug: Aumolertinib

Interventions

Aumolertinib DRUG

Aumolertinib treatment (110mg, p.o., QD) for 8 weeks

Neoadjuvant Aumolertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 9 g/dl.
• Liver: Bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times ULN.
• Kidney: Serum creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 ml/min.
• 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:
• Postmenopausal is defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
• Women under the age of 50 years would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range for the institution.
• Previously undergone irreversible surgical sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (except for bilateral tubal ligation).
• 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.

You may not qualify if:

• 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:
• 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).
• Inability to take oral medications, requirement for parenteral nutrition, previous surgery affecting absorption, or active gastrointestinal ulceration.
• Any significant ocular abnormalities, particularly severe dry eye syndrome, severe dry keratoconjunctivitis, severe exposure keratitis, or other conditions that may increase epithelial damage.
• History of known neurologic or psychiatric disorders, including epilepsy or dementia.
• Insufficient bone marrow reserve or organ function, as indicated by the following laboratory values:
• Absolute neutrophil count (ANC) \< 1.5 × 10\^9/L.
• Platelet count \< 100 × 10\^9/L.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jianxing He, M.D

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenhua Liang, M.D

CONTACT

+86-13710249454; liangwh1987@163.com

Jianxing He, M.D

CONTACT

+86-20-83337792; drjianxing.he@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 14, 2023
• Study Start: August 15, 2023
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

CN (1)