EGFR exon 21 L858R mutation in locally advanced or metastatic non-small cell lung cancer
Conditions
Interventions
experimental group:Osimertinib combined with olanzapine for treatment
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged >= 18 years; 2. Pathologically confirmed non-squamous NSCLC with a definite diagnosis of adenocarcinoma; 3. Newly diagnosed locally advanced (clinical stage IIIB, IIIC) or metastatic NSCLC (clinical stage IVA or IVB) or recurrent NSCLC (International Association for the Study of Lung Cancer 9th edition [IASLC] Thoracic Tumour Staging Manual) not suitable for surgery or radiotherapy; 4. Tissue or liquid molecular pathology test confirming the presence of EGFR mutation exon 21 L858R point mutation, which can be accepted as a result of pathological examination in an outside hospital, providing the test report; 5. WHO PS score: 0-1 and no clinically significant deterioration in the first 2 weeks at screening; 6. expected survival >= 3 months; 7. presence of at least 1 target lesion measurable according to RECIST version 1.1 criteria; 8. Presence of at least 1 measurable lesion that has not been previously irradiated, that can be accurately measured at baseline by CT or MRI up to a maximum diameter of >= 10 mm (lymph node diameter of >= 15 mm), and that can be accurately and reproducibly measured. If only 1 measurable lesion is present, it is required that the lesion has not been previously irradiated and that no biopsy has been performed within the previous 14 days at the time of baseline tumour assessment; 9. compliance, subjects voluntarily enrolled in this study and signed an informed consent form, including adherence to the requirements and limitations outlined in the informed consent form; 10. female or male patients of childbearing potential must use an acceptable method of contraception from screening until at least 6 weeks after discontinuation of study treatment;
Exclusion criteria
Exclusion criteria: 1. Spinal cord compression; patients with symptomatic or unstable brain metastases, or those who have received steroid treatment within the past two weeks; 2. Patients with a history of interstitial pneumonia, including drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid treatment, or any clinically active interstitial pneumonia; 3. Patients with any severe or uncontrolled systemic disease, including uncontrolled hypertension, active bleeding, hepatitis B, hepatitis C, and infection with human immunodeficiency virus (HIV); 4. Patients with abnormal cardiac parameters, including three electrocardiograms (ECGs) demonstrating a mean resting corrected QT interval (QTc) >470 milliseconds; ECGs showing rhythm, conduction, or morphological abnormalities such as complete left bundle branch block, second-degree or third-degree heart block; 5. Patients with any factors increasing the risk of QTc prolongation or arrhythmic events, such as electrolyte abnormalities (potassium, magnesium, calcium), heart failure, congenital long QT syndrome, family history of long QT syndrome, or known concomitant medications prolonging the QT interval; 6. Patients with inadequate bone marrow reserve or organ function, including those with neutropenia, thrombocytopenia, or haemoglobin below normal levels; patients without liver metastases with ALT or AST > 2.5 times the upper limit of normal (ULN), or those with liver metastases with >5 times ULN; patients without liver metastases with total bilirubin > 2.5 times ULN, or those with liver metastases with >3 times ULN; patients with creatinine clearance (CrCL) < 60 mL/min; 7. Patients with confirmed mixed-type NSCLC, where pathology indicates co-occurrence of other histological components such as squamous cell carcinoma, sarcomatoid, or small cell components; 8. Patients with concurrent primary tumours at other sites; 9. Presence of unresolved adverse reactions greater than Grade 1 per CTCAE from prior systemic therapy (e.g., adjuvant chemotherapy) at study treatment initiation, excluding alopecia and Grade 2 platinum-related neuropathy; 10. Patients with refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow medication, or prior intestinal resection potentially affecting drug absorption; 11. Patients who have previously received any systemic therapy for locally advanced or advanced disease, including chemotherapy, targeted therapy, immunotherapy, or any biological therapy; 12. Completion of adjuvant or neoadjuvant therapy within the preceding 3 months. Prior neoadjuvant or adjuvant therapy involving any TKI treatment; 13. Patients who underwent surgery or radiotherapy within the preceding 4 weeks, excluding placement of vascular access, mediastinoscopic biopsy, or video-assisted thoracoscopic surgery (VATS) biopsy. Prior radiotherapy covering =30% of the bone marrow; 14. Use of any drug or herbal supplement considered a strong inducer or inhibitor of cytochrome P450 (CYP) 3A4 within 3 weeks prior to receiving the study drug; 15. Participation in another clinical trial within 4 weeks prior to receiving the study drug. Patients may be included during follow-up periods; 16. Patients unlikely to comply with study procedures, restrictions, and requirements should not participate; 17. Pregnant or lactating women; 18. Individuals with known hypersensitivity to olanzapine, osimertinib, or any of their excipients;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free surviva; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;The one-year no-progress rate;Control rate of brain metastases;Disease-related symptoms and health-related quality of life of cancer patients;Disease control rate;Duration of relief;Self-rating Anxiety/Depression Scale;Overall objective response rate; | — |
Countries
China
Contacts
Public ContactLihong Liu
China-Japan Friendship Hospital
Outcome results
None listed