lung cancer
Conditions
Interventions
Test group: Cardonimumab puls Anlotinib
Sponsors
the Third Affiliated Hospital of Sun Yat sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Agree to sign the informed consent form. 2. Age >= 18 years, male or female. 3. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (stages IIIB, IIIC, or IV according to the AJCC version 8 staging system); EGFR/ALK mutations have been previously treated with TKI; advanced stage or metastatic stage of the disease received systemic therapy = 2 lines. 4. Received PD-1/PD-L1 monoclonal antibody or combination therapy for = 3 treatment cycles in the advanced stage of the disease; radiologically confirmed disease progression occurred during or after the most recent treatment. 5. Expected survival time > 12 weeks. 6. ECOG score = 1.5 × 10?/L (1,500/mm³). ii. Platelet count >= 100 × 10?/L (100,000/mm³). iii. Hemoglobin >= 90 g/L. b) Kidney: i. Calculated creatinine clearance rate (CrCl) >= 50 mL/min. CrCl will be calculated using the Cockcroft - Gault formula (Cockcroft - Gault formula) CrCL (mL/min) = [(140 - age) × weight (kg) × F]/ (SCr (mg/dL) × 72) where F = 1 for males and F = 0.85 for females; SCr = serum creatinine. ii. Urine protein = 28 g/L. d) Coagulation function: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) = 50%.
Exclusion criteria
Exclusion criteria: 1. In addition to the tumor that the subject had at the time of enrollment in the study, there was an active malignancy within 2 years prior to the first dose. Subjects with locally curable tumors (manifested as cured), such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or breast carcinoma in situ, are not excluded. 2. Central lung squamous cell carcinoma or risk of major hemoptysis. 3. Previously received experimental drug treatment or used an experimental device within 4 weeks prior to the first dose. 4. Concurrent enrollment in another clinical study, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study (defined as more than 4 weeks after the first dose of the previous clinical study or more than 5 half-lives of the investigational drug). 5. Received Chinese patent medicines with anti-tumor indications or Chinese herbal medicines with anti-tumor effects, or immunoregulatory drugs (thymosin, interferon, interleukin) within 2 weeks before the first dose. 6. Subjects with active, known or suspected autoimmune disease, or a history of autoimmune disease, except for vitiligo, alopecia, Graves' disease, psoriasis, or eczema that have not required systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) that is asymptomatic or requires only a stable dose of hormone replacement therapy, type 1 diabetes that requires only a stable dose of insulin replacement therapy, or complete remission of childhood asthma without any intervention as adults, or who have a disease that does not recur without external triggers. 7. Subjects requiring systemic therapy with corticosteroids (> 10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days prior to the first dose. 8. Known history of immunodeficiency. 9. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 10. Major surgical procedures (e.g.: laparotomy, thoracotomy, excision, etc.), severe trauma, etc. have been performed within 28 days prior to the first dose (acceptable for replacement of intravenous dropper); Surgery to improve tumor complications or reduce the risk of tumor complications has been performed within 14 days prior to the first dose; or has not fully recovered from the above prior surgeries. Major surgical procedures are planned within 30 days of the first dose (as determined by the investigator). Local procedures (e.g., placement of systemic ports, core needle biopsy, and prostate biopsy) are permitted provided that the procedure is completed at least 24 hours prior to the first dose of the investigational therapeutic drug. 11. A history of gastrointestinal perforation, gastrointestinal fistula, and female genital fistula (e.g., vesicovaginal fistula, urethra-vaginal fistula, vesicocervical fistula, etc.) within 6 months before the first dose; if the perforation or fistula has been treated by resection or repair, and the investigator judges that the disease has recovered or repaired, the group can be admitted. 12. Known presence of interstitial lung disease that is symptomatic or may impede the detection or management of suspected drug-related pulmonary toxicity. 13. Active tuberculosis (TB) is known to be present. Subjects suspected of having active TB should be examined for chest X-rays, sputum, and ruled out by clinical signs and symptoms. 14. Pregnant o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Duration of Response, DOR;Progression free survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactMin Dong
the Third Affiliated Hospital of Sun Yat sen University
Outcome results
None listed