Advanced non-small cell lung cancer
Conditions
Interventions
Experimental group:almonertinib combined with vinorelbine
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Confirmed by histological or cytological examination, and being locally advanced (stage IIIB/III C) or metastatic (stage IV) NSCLC that is not suitable for radical surgery and/or radical radiotherapy [according to the International Association for the Study of Cancer and the American Joint Committee on Cancer (AJCC) 9th edition of the lung cancer TNM staging]; 3. Genetic testing shows the presence of EGFR sensitive mutations (EGFR19del or L858R); 4. Before enrollment, no systemic anti-tumor treatment has been received for advanced/metastatic NSCLC; 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), at least one measurable lesion; 6. ECOG score 2-4, and judged by the investigator as not suitable for any platinum-based double-drug chemotherapy; 7. Expected survival >= 3 months; 8. Patients with asymptomatic central nervous system metastases, if all the following criteria are met, they are eligible: a. There is a measurable lesion outside the CNS b. Only supratentorial and cerebellar metastases (i.e., no midbrain, pons, medulla oblongata or spinal cord metastases) are allowed c. No continuous use of corticosteroids for CNS diseases is required; stable doses of anticonvulsant drugs are allowed d. Within 7 days before enrollment, no stereotactic radiotherapy was performed, or within 14 days no whole brain radiotherapy was performed e. No evidence of progression during the screening period imaging examination; new asymptomatic CNS metastases are found during the screening period scan, if all other criteria (including clinical confirmation of no disease progression during the period) are met, these patients may be eligible and no additional brain scans are required before randomization. 9. Patients judged by the investigator to have no contraindications, that is, the main organ functions should meet the following standards: a. Blood routine (within 14 days before screening, no blood transfusion or use of hematopoietic stimulating factor drugs to correct): white blood cell count (WBC) >= 3.0 × 10^9/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelet (PLT) >= 100 × 10^9/L; hemoglobin content (HGB) >= 90 g/L; b. Liver function: for non-liver metastasis subjects, aspartate transferase (AST) <= 2.5 x ULN; alanine aminotransferase (ALT) <= 2.5 x ULN; for liver metastasis subjects, ALT and AST <= 5 x ULN; serum total bilirubin (TBIL) <= 1.5 x ULN (excluding Gilbert syndrome, total bilirubin <= 3.0 mg/dL); c. Renal function: serum creatinine <= 1.5 x ULN (unit of serum creatinine is concentration); d. No significant abnormalities in other biochemical indicators. 10. Voluntary signing of the informed consent approved by the ethics committee.
Exclusion criteria
Exclusion criteria: If the subjects meet any of the following criteria, they will not be included in this study: 1. Tumor histology or cytology confirms the presence of small cell lung cancer, neuroendocrine cancer, or carcinosarcoma components; 2. There is an active infection that requires antibiotic treatment; 3. History of interstitial lung disease, drug-induced pneumonia, systemic glucocorticoid treatment for radiation pneumonia or active interstitial pneumonia; 4. The ECOG PS score is reduced due to comorbidities; 5. Based on the brain CT or magnetic resonance imaging assessment during the screening period and previous imaging evaluations, there is active CNS metastasis a. Spinal cord compression that has not been treated by surgery and/or radiotherapy, or previously diagnosed and treated spinal cord compression without evidence that the disease was clinically stable for > 2 weeks b. Meningeal disease c. History of intracranial hemorrhage from CNS metastases; 6. Uncontrolled tumor-related pain a. Patients requiring analgesics at the time of study enrollment must be on a stable treatment regimen b. Symptomatic lesions (such as bone metastases or those causing nerve compression) that are suitable for palliative radiotherapy should be treated before enrollment; patients should recover from the effects of radiotherapy; there is no mandatory minimum recovery period c. For asymptomatic metastatic lesions, if their further growth may lead to functional impairment or refractory pain (such as current epidural metastases without spinal cord compression), local treatment should be considered before enrollment; 7. Uncontrolled pleural effusion, pericardial effusion or ascites that require repeated drainage operations (once a month or more frequently). Patients with indwelling catheters for drainage of fluid are allowed; 8. Within <= 2 years prior to the first dose, concurrent other malignant tumors, fully treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, locally advanced prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, excluding non-metastatic prostate cancer or breast cancer treated with hormone therapy (allowing non-metastatic prostate cancer or breast cancer hormone therapy); 9. Any toxicity (except hair loss) caused by previous treatment (such as radiotherapy) that is grade 3 or higher according to CTCAE (v5.0) and has not improved and is strictly considered to interfere with the current study medication; 10. Patients who have received neoadjuvant, adjuvant chemotherapy, radiotherapy or radiochemotherapy (aimed at cure) for non-metastatic diseases, and must have at least a 6-month treatment-free interval from the last chemotherapy, radiotherapy or radiochemotherapy to enrollment; 11. Within 3 weeks before enrollment, received any anti-tumor drug treatment (including anti-tumor traditional Chinese medicine), or received any other investigational drug treatment, or participated in another interventional clinical study; 12. Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption, such as inability to take oral medication, uncontrollable nausea or vomiting, extensive history of gastrointestinal resection, untreated recurrent diarrhea, atrophic gastritis, untreated long-term use of proton pump inhibitors for gastric diseases, Crohn's disease, ulcerative colitis, etc.; 13. Major surgical history of stomach or small intestine resection; 14. Pregnan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Adverse event;Duration of relief;Overall survival;Complete Response;Partial Response; | — |
Countries
China
Contacts
Public ContactPanwen Tian
West China Hospital of Sichuan University
Outcome results
None listed