Non-small cell lung cancer
Conditions
Interventions
Treatment Group:Almonertinib Combined with Vinorelbine Tartrate Soft Capsules
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations (19del and L858R) confirmed by tissue or blood-based genetic testing. 2.Documented disease progression (local or systemic progression) following prior treatment with a third-generation EGFR-TKI, and all toxic reactions induced by prior treatments have resolved to = 65 years who have signed the informed consent form. 4.Subjects with asymptomatic brain metastases or brain metastases under stable control. 5.ECOG performance status score of 0–3 and an expected survival of more than 3 months. 6.Subjects must undergo tissue or blood sample genetic testing to confirm mutation type after enrollment; alternatively, subjects who are unable to undergo sample testing due to objective reasons may be enrolled for treatment after clinical evaluation and judgment by the investigators. 7.Normal function of major organs, defined as meeting the following laboratory criteria: (1) Hematological criteria (no blood transfusion, blood products, G-CSF or other hematopoietic stimulants administered within 14 days prior to testing): a. Hemoglobin >= 90 g/L; b. Absolute neutrophil count (ANC) >= 1.5×10^9/L; c. Platelet count >= 100×10^9/L. (2) Biochemical criteria: a. Total bilirubin 25 mL/min (using the Cockcroft-Gault formula). 8.Women of childbearing potential must use adequate contraceptive measures from screening until 3 months after discontinuation of study treatment and must not breastfeed. A negative pregnancy test result is required prior to the first dose of study treatment, or subjects must meet one of the following criteria to confirm no pregnancy risk: a. Postmenopausal status, defined as aged > 50 years with amenorrhea for at least 12 consecutive months without exogenous hormone replacement therapy; b. For women aged < 50 years, postmenopausal status can also be confirmed if they have had amenorrhea for at least 12 consecutive months without exogenous hormone replacement therapy and their luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels are within the postmenopausal reference range of the testing laboratory; c. History of irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy or bilateral salpingectomy (bilateral tubal ligation is excluded). 9.Male subjects must use barrier contraception (i.e., condoms) from screening until 3 months after discontinuation of study treatment. 10.Subjects voluntarily agree to participate in this study, are able to communicate effectively with investigators, and can comply with the study requirements including scheduled visits, treatment administration, laboratory tests and other related procedures.
Exclusion criteria
Exclusion criteria: 1.Mixed-type lung cancer with components of small cell carcinoma, neuroendocrine carcinoma, or sarcoma. 2.Patients with brain metastases presenting with severe symptoms at the initiation of treatment. 3.Detection of other drug-resistant mutations (e.g., MET amplification, etc.) besides EGFR mutations via tissue or blood-based genetic testing. 4.Patients who refuse to receive the treatment regimen specified in this study. 5.Medical history or comorbidities: a. Patients with symptomatic brain metastases, carcinomatous meningitis, or spinal cord compression; or those with radiologically confirmed brain or leptomeningeal lesions on CT or MRI at screening (patients with brain metastases who have completed treatment and achieved stable symptoms within 14 days prior to enrollment may be eligible, provided that cranial MRI, CT or venography confirms the absence of cerebral hemorrhage symptoms). b. Patients who are currently participating in other clinical studies or whose interval from the end of treatment in the previous clinical study is less than 4 weeks. c. Presence of other active malignant tumors requiring concurrent treatment. d. History of other malignant tumors (excluding adequately treated non-melanoma skin cancer, carcinoma in situ, or other solid tumors with no evidence of disease for more than 5 years after treatment). e. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease. f. Coagulopathy (international normalized ratio [INR] of prothrombin time > 1.5; prothrombin time [PT] > ULN + 4 seconds; or activated partial thromboplastin time [APTT] > 1.5 × ULN), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy. Note: Low-dose heparin (daily dosage of 6,000–12,000 U for adults) or low-dose aspirin (daily dosage 470 msec on three resting electrocardiograms (ECG), with QT interval correction using the Fridericia formula (QTcF); resting ECG showing clinically significant rhythm, conduction or morphological abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, or PR interval > 250 msec); presence of any factors increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death in first-degree relatives under 40 years old, or concurrent use of any drugs that prolong QT interval; left ventricular ejection fraction (LVEF) 50 mL) within 3 months prior to enrollment; or clinically significant bleeding symptoms or definite bleeding t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate, ORR;Disease Control Rate, DCR;Duration of Response, DoR; | — |
Countries
China
Contacts
Public ContactDongying Liu
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed