non-small cell lung cancer
Conditions
Interventions
Test group:Chidamide Combined with Pemetrexed, Platinum-Based Chemotherapy, and Endostar
Sponsors
Fujian Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: ??1. Age??: 18–75 years, regardless of gender. ??2. Diagnosis??: Pathologically confirmed unresectable locally advanced or metastatic (stage IV) NSCLC with EGFR exon 19 deletion (19Del) or exon 21 L858R mutation. ??3. Prior Treatment??: Patients with extensive progression after standard first-line EGFR-TKI therapy (first-, second-, or third-generation). Post-resistance genetic testing must confirm absence of EGFR T790M mutation (for first-/second-generation TKI resistance) or other bypass-activated driver mutations (for third-generation TKI resistance). ??4. Measurable Lesions??: At least one measurable target lesion per RECIST 1.1 criteria (tumor lesion >=10 mm in longest diameter on CT scan; lymph node >=15 mm in short axis; slice thickness 5 mm). ??5. ECOG PS Score??: 0–2. 6.?? Expected Survival??: >=3 months. ??7. Recovery from Prior Therapies??:>=6 weeks since nitrosourea/mitomycin treatment >=4 weeks since cytotoxic drugs, radiotherapy, or surgery (with fully healed wounds). ??8. Normal function of major organs, meeting the following criteria: (1) Hematological examination criteria (without blood transfusion within 14 days): a. HB >= 90 g/L, b. WBC >= 3.5 × 10?/L, c. ANC >= 1.5 × 10?/L, d. PLT >= 75 × 10?/L; (2) Biochemical tests must meet the following criteria: a. BIL 50 mL/min (Cockcroft-Gault formula); 9. Women of childbearing potential must have a negative pregnancy test (serum) within 7 days before enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the investigational drug. Men must be surgically sterilized or agree to use appropriate contraception during the trial and for 8 weeks after the last dose of the investigational drug. 10. Participants must voluntarily join the study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Chemotherapy Contraindications. 2. Prior Chidamide Use: Previous treatment with chidamide or chemotherapy within 140 mmHg, diastolic >90 mmHg). 9. Cardiovascular Issues: Coronary artery disease (grade =1), arrhythmias (QTc >450 ms [male) or >470 ms [female], or cardiac insufficiency. 10. Bleeding Risk: Gastrointestinal bleeding history (eg, melena/hematemesis within 2 months) or coagulopathy (INR >1.5, APTT >1.5×ULN). 11. Thrombolytic/Anticoagulant Use: Active cerebrovascular disease requiring medication. 12. Autoimmune Diseases: Active or suspected autoimmune conditions (exceptions: stable hypothyroidism, type 1 diabetes, or skin diseases not requiring systemic therapy). 13. Immunodeficiency: HIV positivity, organ/bone marrow transplantation history. 14. Oother Severe Comorbidities: As judged by the investigator. 15. Neurological/Psychiatric Disorders: Uncontrolled epilepsy, CNS diseases, or conditions affecting drug adherence (e.g, dysphagia, chronic diarrhea). 16. Allergies: Hypersensitivity to study drugs or excipients. 17. Investigator Discretion: Other factors deemed unsuitable for inclusion.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;disease control rate;overall survival; | — |
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactZhenhua Liu
Fujian Provincial Hospital
Outcome results
None listed