Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the efficacy and safety of Icotinib as neoadjuvant in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

Inclusion Criteria:

• Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion or plasma ctDNA

• No previous anti-tumor treatment such as surgery, chemotherapy, radiotherapy or biological therapy

• Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS) or PET-CT, the short-axis diameter of lymph node 1-2cm, and considered surgically resectable at baseline by the surgical oncologist

• Sufficient tumor histological specimens (non-cytology) for molecular marker analysis

• At least one lesion with measurable diameter and its longest diameter is large than 10 mm by CT measurement

Exclusion Criteria:

• Previous systemic anti-tumor treatment of Non-small Cell Lung Cancer, including cytotoxic drug therapy, targeted drug therapy (tyrosine kinase inhibitors or monoclonal antibodies) and experimental treatment, etc

• Previous local radiotherapy of Non-small Cell Lung Cancer

• Be allergic to any component of Icotinib tablet (Conmana)

• Other cancers within five years prior to the treatment of this study. Except for cervical carcinoma, basal cell carcinoma and bladder epithelial neoplasm (including Ta and Tis)

• Any instable systemic disease, including: active infection, high blood pressure out of control, unstable angina, onset of angina pectoris within the past 3 months, congestive heart failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic disease

• Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy or any active intersexual lung disease with clinical evidence

• Idiopathic pulmonary fibrosis detected by CT scan at baseline;

• Not fully controlled eye inflammation or infections, or any condition that may lead to the above eye diseases

• Human immunodeficiency virus infection

• Patients undergoing major surgery or severe trauma within 2 months prior to the first use of the experimental drug

• Patients with Small Cell Lung Cancer

• Pregnant or lactating women

• Neurological or psychiatric disorders history, including epilepsy or dementia

• Other situations not appropriate to enter the group considering by the investigators