NSCLC
Conditions
Interventions
Test group (Dose exploration stage):Six eligible patients are randomly assigned to two groups. One group receives 80 mg of Furmonertinib Mesilate QD and 600 mg of Adebrelimab Q3W, while the other grou
Test group (Dose Expansion Stage):Adebrelimab 1200 mg IV, Day 1, Q3W
Furmonertinib Mesylate 80 mg PO QD
continue until disease progression or intolerability, with a maximum treatment duration of 2 years for Adebrelimab.
Sponsors
Cancer Hospital Affiliated of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects should be aged between 18 and 75 years old at the time of signing the informed consent form, regardless of gender. 2. Patients with histologically or cytologically confirmed unresectable or those who decline surgical resection of non - small cell lung cancer. 3. Positive for EGFR - driven gene mutations. 4. PD - L1 >= 50%. 5. Have not previously received systemic treatment for advanced/metastatic non-small cell lung cancer. Systemic treatment or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy, provided that the treatment ended at least 6 months before the diagnosis of advanced or metastatic disease. 6. According to the RECIST 1.1 criteria, patients must have measurable lesions detectable by CT or MRI. Tumor imaging evaluation should be conducted within 28 days before the first dose of the drug. 7. ECOG performance status: 0 - 1. 8. Expected survival time >= 3 months. 9. Meet the laboratory indicators specified in the study protocol, including: 1) Hemoglobin (HB) >= 90 g/L (without blood transfusion within 14 days before screening). 2) Absolute neutrophil count (ANC) >= 1.5×10?/L. 3) Platelet count (PLT) >= 80×10?/L. 4) Bilirubin 45 ml/min (using the Cockcroft - Gault formula). 8) Coagulation function: Activated partial thromboplastin time (APTT), International normalized ratio (INR), and Prothrombin time (PT) 1.5×ULN but without clinically or radiologically confirmed pancreatitis can be enrolled. 10) Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) >= 50%. 10. Have voluntarily signed the informed consent form, and be willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures. 11. Female subjects of child - bearing potential must have a negative serum pregnancy test within 72 hours before the first dose of the drug, not be breastfeeding, and be willing to use a medically recognized highly effective contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study period and for 3 months after the last administration of Adebrelimab/Apatinib or 6 months after the last administration of Albumin - bound Paclitaxel (whichever is longer). Male subjects whose partners are of child - bearing potential should have undergone surgical sterilization or agree to use effective contraceptive methods during the study period and for 3 months after the last study drug administration, and are not allowed to donate sperm during the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with histological or cytological pathological confirmation of components of small cell lung cancer or sarcomatoid carcinoma lesions. 2. Subjects with negative EGFR mutations. 3. Subjects with PD-L1 30 Gy of thoracic (lung) radiotherapy within 6 months before the study treatment, except for local palliative radiotherapy for bone metastasis lesions. 14. Received traditional Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (such as thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration, or underwent major surgery within 4 weeks before the first administration and have not fully recovered from the previous surgery. 15. Patients with active tuberculosis (TB), those who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening. 16. Subjects with obvious symptomatic brain metastases. 17. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage (once a month or more frequently). Subjects can be enrolled if their symptoms are stable for at least 2 weeks after drainage. 18. Clinically uncontrolled active infections, including but not limited to acute pneumonia. 19. Previously or currently suffering from other malignancies (except non-melanoma basal cell carcinoma or squamous cell carcinoma of the skin, in-situ breast cancer/cervical cancer, superficial bladder cancer, etc. that have been radically treated and have no evidence of disease recurrence). 20. Subjects with a history of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, evidence of active pneumonia found during chest CT scan screening, or other moderate to severe lung diseases that seriously affect lung function. 21. Known clinically significant liver diseases, including untreated active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, he
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 12-month Progression-Free Survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress-Free Survive;Objective Response Rate;Disease Control Rate;Overall Survival;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactMeng Xiangjiao
Cancer Hospital Affiliated to Shandong First Medical University (Shandong Cancer Hospital)
Outcome results
None listed