completely resected IB-IIIA non-small cell lung cancer (NSCLC) patients with uncommon EGFR mutations (except for 20ins)
Conditions
Interventions
Almonertinib group:Targeted Therapy Intervention
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1: Age = 18 years old, gender is not limited 2: Histologically confirmed primary non-squamous NSCLC 3: Computed tomography (CT) or magnetic resonance scan (MRI) of the brain is required before surgery 4: Postoperative pathological confirmation indicates stage IB-IIIA (N1-N2), in which stage IB patients must include at least one high-risk factor, such as poorly differentiated tumors, vascular infiltration, wedge resection, visceral pleural involvement, unknown lymph node status (Nx), or other clinically considered high-risk factors; 5: Tumor tissue samples or blood samples diagnosed with stage IB-IIIA NSCLC are confirmed to be rare mutations in EGFR by laboratory tests [including rare mutations such as G719X, L861Q, S768I, and other EGFR site mutations alone or coexisting (except Ex19Del, L858R, T790M) and Ex20Ins) are available]. If tumor tissue is accessible, it is recommended to send tumor tissue. if tumor tissue is not accessible or the patient cannot accept tissue biopsy, blood sample is sent for testing 6: Primary NSCLC requires complete resection with negative margins 7: At enrollment, patients had fully recovered from surgery or postoperative adjuvant chemotherapy (if adjuvant chemotherapy was used) 8: WHO performance status score is 0-1 9: Females of childbearing potential should use appropriate contraception and should not breastfeed from screening to 3 months after discontinuation of study treatment. Negative pregnancy test before starting dosing 10: Male patients should use barrier contraception (i.e. condoms) from screening to 3 months after discontinuation of study treatment 11: The subjects themselves participated voluntarily and signed the informed consent in writing
Exclusion criteria
Exclusion criteria: 1: Received any of the following treatments: a. Any anti-tumor therapy b. Preoperative or postoperative or planned radiotherapy c. Preoperative neoadjuvant therapy with platinum-based or other chemotherapy d. Previous use of any EGFR Treatment with tyrosine kinase inhibitor e. The patient has undergone major surgery within 4 weeks before the first dose f. Received other experimental drugs, and within 5 half-lives g. Within 7 days before the first dose of the study drug, use Drugs with a narrow therapeutic window over strong CYP3A4 inhibitors, inducers or CYP3A4 sensitive substrates. 2: Patients who underwent segmentectomy and wedge resection only 3: History of other malignancies, except for effectively treated non-melanoma skin cancer, carcinoma in situ, or other solid tumors, and no evidence of any disease >5 years after last treatment 4: Unresolved residual toxicity from prior therapy greater than CTCAE Grade 1 at initiation of study treatment, with the exception of alopecia and grade 2 neurotoxicity from prior chemotherapy 5: Patients with any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, that the investigator considers unsuitable to participate in the study or affect adherence to the trial protocol, or active infection including type B, Hepatitis C, HIV 6: Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drug or previous extensive bowel resection, which may interfere with adequate absorption of almonertinib 7: Any one of the following cardiac findings: a. Mean corrected QT interval (QTc) > 470 msec from 3 resting electrocardiogram (ECG) exams, QT interval corrected (QTcF) using the Fridericia formula b. Resting ECG suggestive of various clinically significant rhythm, conduction or ECG morphological abnormalities (eg complete left bundle branch block, 3rd degree AV block, 2nd degree AV block and PR interval > 250 msec), c. The presence of any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or immediate family members under the age of 40 of unexplained sudden death or any concomitant drug that prolongs the QT interval 8: History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease 9: Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to the first dose of study treatment 10: Insufficient bone marrow reserve or organ function 11: A history of hypersensitivity to any active or inactive ingredient of almonertinibor to a drug that is chemically similar to or of the same class as almetinib 12: Any serious or uncontrolled ocular disease that, in the judgment of the physician, may increase the risk to the patient's safety 13: Patients who, in the judgment of the investigator, may not be in compliance with the procedures and requirements of the study 14: Patients who, in the judgment of the investigator, have any condition that compromises patient safety or interferes with study evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival;overall survival, OS;Median DFS; | — |
Countries
China
Contacts
Public ContactChang Chen
Shanghai Pulmonary Hospital
Outcome results
None listed