Lung cancer
Conditions
Interventions
Treatment group:Treatment regimen combining carilizumab with chemotherapy, simultaneously using Thalidomide and carilizumab
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Patients diagnosed with advanced non-small cell lung cancer (NSCLC) by histopathology or cytology. 2.Planning to receive a treatment regimen of carilizumab combined with platinum-based doublet chemotherapy. 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4.Aged 18 years or older. 5.Expected survival of at least 12 weeks. 6.No prior treatment with immune checkpoint inhibitors (ICIs), including PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other treatments targeting the PD-1/PD-L1 pathway. 7.Able to swallow tablets normally. 8.Have adequate organ and bone marrow function, defined as follows: (1) Absolute neutrophil count (ANC) = 1,500/mm3 (1.5×10^9/L); (2) Platelet count (PLT) = 90,000/mm3 (90×10^9/L); (3) Hemoglobin (Hb) = 8g/dL (80g/L); (4) Serum creatinine (Cr) = 1.5 times the upper limit of normal (ULN); (5) Total bilirubin (BIL) = 1.5 times ULN; (6) Aspartate transaminase (AST) and alanine transaminase (ALT) levels = 3 times ULN; if liver metastasis is present, AST and ALT levels = 5 times ULN; (7) International normalized ratio (INR) = 1.5, prothrombin time (PT), and activated partial thromboplastin time (APTT) = 1.5 times ULN; (8) Thyroid-stimulating hormone (TSH) = ULN; if abnormal, investigate levels of free triiodothyronine (FT3) and free thyroxine (FT4); participants with normal levels of FT3 and FT4 are eligible for inclusion. 9.Female participants of reproductive potential must undergo a blood pregnancy test within 72 hours before the first dose, with a negative result, and not be breastfeeding. They must agree to use effective contraception during the trial and for 2 months after the last dose of the study drug. For male participants with female partners of reproductive potential, they should undergo surgical sterilization or agree to use effective contraception during the trial and for 2 months after the last dose of the study drug. Donating sperm is not allowed during the study period.
Exclusion criteria
Exclusion criteria: 1.Known allergy to the investigational drug or excipients, or experiencing severe allergic reactions to other monoclonal antibodies. 2.Use of immunosuppressive drugs within 14 days prior to the first use of carilizumab, excluding daily doses of =10mg prednisone or equivalent corticosteroids, or nasal spray topical corticosteroids. 3.Vaccination with live attenuated vaccines within 4 weeks before the first dose or planning to receive during the study. 4.Patients with symptomatic, visceral metastases, and short-term risks of life-threatening complications. 5.Patients with interstitial pneumonia or interstitial lung disease, or with a history of such conditions, or other subjects that may interfere with the assessment and management of immune-related pulmonary toxicity. 6.Presence of any active autoimmune disease or history of autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism), except for subjects with thyroid hypothyroidism who only require hormone replacement therapy, and subjects with skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) can be included. 7.Human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA = 500 IU/mL), hepatitis C (positive HCV antibody, and HCV-RNA higher than the detection limit of the analysis method), or combined hepatitis B and hepatitis C co-infection. 8.Central nervous system (CNS) metastases or presence of cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. 9.Experienced cardiovascular events within 6 months prior to enrollment, such as acute cerebral infarction, acute coronary syndrome, etc., and cardiovascular clinical symptoms or diseases not well controlled. (1) New York Heart Association (NYHA) class 2 or above heart failure; (2) Left ventricular ejection fraction (LVEF) 1.5 or APTT > 1.5 × ULN), with a bleeding tendency or receiving thrombolytic or anticoagulant therapy. 11.Significant hemoptysis within 2 months prior to enrollment, or daily hemoptysis of half a teaspoon (2.5 ml) or more. 12.Significant bleeding symptoms or clear bleeding tendencies within 3 months prior to enrollment. 13.Venous/arterial thromboembolic events within 6 months prior to enrollment. 14.Active infections (CTCAE> Grade 2), or signs of infection such as unexplained fever >38.5°C within the past 2 weeks (excluding tumor-related fever), such as severe pneumonia requiring hospitalization, septicemia, infection complications, etc., except for prophylactic use of antibiotics. 15.Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 16.Participation in any other drug clinical trials within 4 weeks prior to the first dose, or within 5 half-lives of the last study drug administration. 17.Known history of substance abuse or drug addiction. 18.Other abnormalities that may increase the risk of participation, interfere with study results, or are deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of RCCEP; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of RCCEP at grade G3 and above;Time of occurrence to the median of RCCEP;Adverse events related to thalidomide;PFS;ORR;6-week RCCEP incidence rate;9-week RCCEP incidence rate; | — |
Countries
China
Contacts
Public ContactShuanying Yang
The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed