Postoperative histopathology confirmed R0 resection in patients with stage IB-IIIA lung adenocarcinoma.
Conditions
Interventions
MRD positive:2 years of postoperative adjuvant treatment with Iruplinalkib
MRD negative:1 years of postoperative adjuvant treatment with Iruplinalkib
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Disease-related Inclusion Criteria: Postoperative histopathology confirmed R0 resection in patients with stage IB-IIIA lung adenocarcinoma. Confirmed ALK-positive status through FISH, IHC, or NGS. Patients must have fully recovered from surgery or standard postoperative chemotherapy before starting adjuvant treatment. At the time of treatment initiation, patients must have recovered from all toxicities greater than grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia and grade 2 neuropathy related to prior platinum-based therapy. No evidence of tumor recurrence or metastasis on imaging examinations prior to adjuvant treatment. Sufficient tumor tissue (non-cytological) must be available for molecular biomarker analysis. Hematological, Biochemical, and Organ Function Criteria: Hemoglobin >= 100 g/L. Absolute neutrophil count >= 1.5 × 10^9/L. Platelet count >= 100 × 10^9/L. Total bilirubin = 60 mL/min. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to starting treatment. General Inclusion Criteria: Obtained informed consent from the patient or their legal representative. Good patient compliance. Ability to take oral medication. Age between 18 and 75 years. ECOG performance status score of 0 to 2. Male and female patients of childbearing potential must agree to use reliable contraception methods from the time of entering the trial until 8 weeks after discontinuation of the study drug.
Exclusion criteria
Exclusion criteria: 1.Exclusion Criteria: Previous targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies) or experimental treatment for NSCLC. Previous local radiotherapy for NSCLC. Inability to take oral medication. Clinical objective evidence (pathological or imaging) of tumor recurrence prior to the initiation of adjuvant treatment. Inability to obtain sufficient tumor tissue (non-cytological) for molecular biomarker analysis. Known allergy to Iruplinalkib or any component of this product. History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; 2.baseline CT scan showing idiopathic pulmonary fibrosis. Any unstable systemic disease, including: active infection, uncontrolled hypertension, unstable angina, angina that started within the last 3 months, congestive heart failure (NYHA class II or greater), myocardial infarction within the last 6 months, severe arrhythmias requiring medication, liver, kidney, or metabolic diseases. Pregnant or breastfeeding women. History of significant neurological or psychiatric disorders, including epilepsy or dementia. Any other condition that the investigator deems inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;3-year OS rate;Disease-free survival; | — |
Countries
China
Contacts
Public ContactHaiyu Zhou
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed