Advanced EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Conditions
Interventions
Experimental group:The treatment regimen consists of an initial combination phase followed by maintenance therapy. Patients will receive Liotinib (80 mg orally twice daily) in combination with pemetre
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent obtained before any trial-related procedures are performed. 2. Aged >=18 years and 3 months. 12. Adequate organ function, defined by the following laboratory values within a specified period prior to enrollment: 1) **Hematological:** Absolute neutrophil count (ANC) >=1.5 x 10?/L without granulocyte colony-stimulating factor support within 14 days; Platelet count (PLT) >=100 x 10?/L without transfusion within 14 days; Hemoglobin (Hb) >9 g/dL without transfusion or erythropoietin use within 14 days. 2) **Hepatic:** Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =60 mL/min. 4) **Coagulation:** International normalized ratio (INR) or prothrombin time (PT) =1 year of amenorrhea) or those who are surgically sterilized or have undergone hysterectomy are not considered of childbearing potential. 14. All patients (male and female) with reproductive potential must use highly effective contraception (failure rate <1% per year) during the treatment period and for at least 120 days (or 180 days, if applicable based on the specific drug's pharmacokinetics) after the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Pathological diagnosis of small cell lung cancer (SCLC), including combined SCLC and NSCLC, or adenosquamous carcinoma. 2. Presence of an EGFR exon 20 insertion (20ins) mutation. 3. Primary resistance to prior EGFR-TKI therapy, defined as progression-free survival (PFS) of less than 3 months. 4. Prior receipt of any of the following treatments: 1) Any prior chemotherapy, other targeted therapies (excluding EGFR-TKIs), or immune checkpoint inhibitors in the locally advanced or metastatic setting. 2) Treatment with any investigational drug within 4 weeks prior to the start of study therapy. 3) Major surgery (e.g., thoracotomy, laparotomy) within 4 weeks prior to treatment, or presence of unhealed surgical wounds, ulcers, or fractures. 4) Radiation therapy: >30 Gy to the chest within 6 months prior to the first dose; >30 Gy to non-chest areas within 4 weeks prior to the first dose; or palliative radiation therapy (<=30 Gy) within 2 weeks prior to the first dose. 5. Clinically uncontrolled pleural effusion, ascites, or pericardial effusion. (Patients who do not require drainage or whose effusion remains stable without significant increase for 3 days after stopping drainage may be eligible.) 6. History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 7. Leptomeningeal metastasis; or symptomatic central nervous system (CNS) metastases. 8. Known hypersensitivity to the active pharmaceutical ingredient or any excipients of Liotinib. 9. Has not recovered (i.e., to <= Grade 1 or baseline, excluding fatigue or alopecia) from adverse events and/or complications due to any prior interventions prior to the start of treatment. 10. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies). Untreated active hepatitis B; or active hepatitis C infection (positive HCV antibody with HCV-RNA levels above the lower limit of detection). Known active tuberculosis (TB): patients with suspected active TB must be evaluated clinically to exclude it. Known active syphilis infection. 11. Administration of a live or live-attenuated vaccine within 30 days prior to the first dose of study drug (Cycle 1, Day 1). *Note: Seasonal influenza vaccines that are inactivated are permitted within 30 days prior to the first dose. However, intranasal live attenuated influenza vaccines are not permitted.* 12. Women who are pregnant or breastfeeding, or planning to breastfeed during the study period. 13. Any severe or uncontrolled systemic disease; known history of psychiatric disorder, drug abuse, alcoholism, or substance dependence. 14. Any other condition or circumstance that, in the investigator's judgment, may pose an unacceptable risk or make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;Overall survival;Safety and tolerability; | — |
Countries
China
Contacts
Public ContactLi Jisheng
Qilu Hospital of Shandong University
Outcome results
None listed