NSCLC
Conditions
Interventions
PD-L1 TPS group:Induction therapy phase: PD-L1 TPS=50% of subjects plus ivoximab 20mg/kg Q3W, PD-L1 TPS=50% of subjects received ivoximab 20mg/kg Q3W for 3 cycles of induced therapy. Combination Treat
Non-squamous carcinoma: pemetrexed 500mg/m2 Q3W carboplatin AUC5 Q3W
). The dose fractionation regimen for radiotherapy is: (60/-10%Gy)/1.8-2.2Gy times, 5 times a week, simultaneous dose
Sponsors
Shandong First Medical University Affiliated Tumor Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed written informed consent Study participants must sign and sign the IRB/IEC approved informed consent form in accordance with the guidelines of the competent authorities and research institutions on the date. Informed consent must be in place to perform any protocol-related procedures (not part of the Department of routine medical care for study participants sub-contents) before signing. Study participants must be willing and able to comply with the visits, treatment protocols, laboratory tests, and compliance with the schedule Other requirements of the study. 2. Age >=18 years old at the time of enrollment, both male and female; 3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1; 4. Patients with histopathologically or cytologically confirmed non-small cell lung cancer with clinical stage of unresectable stage II and III. stage (according to the International Union Against Cancer and the American Joint Committee on Cancer 8th edition TNM staging for lung cancer); 5. Negative for EGFR sensitive mutations, negative for ALK and ROS1 fusions by histopathological or cytological testing; For non-squamous cell carcinoma study participants (including NSCLC with unclear pathological type), tumor tissue-based EGFR, ALK, ROS1 test results must be provided. If the translocation status of EGFR mutation, ALK, and ROS1 genes is unknown, EGFR, ALK, and ROS1 gene mutation testing must be performed before enrollment; For squamous non-small cell lung cancer study participants, testing at screening is not required if EGFR mutation, ALK, ROS1 gene status is unknown; 6. Have not received any form of anti-tumor therapy in the past; 7. At least one measurable lesion according to RECISTv1.1 and suitable for repeated accurate measurements; 8. PD-L1 expression results in tumor tissues; 9. Whole-body FDGPETCT and FAPIPET/CT, chest contrast-enhanced CT, cranial enhancement within 28 days prior to the start of the study magnetic resonance imaging (MRI) or contrast-enhanced CT of the brain to rule out distant metastases; 10. Determination of good organ function by the following requirements: 1) Hematology (no use of any blood components and cell growth factor supportive therapy within 7 days prior to starting study treatment): i. Absolute neutrophil ANC>=1.5×10^9/L; ii. Platelet count>=100×10^9/L; iii. Hemoglobin > = 90 g/L 2) Kidneys: i. Serum creatinine (Cr) =50mL/min; *CrCl will be calculated using the Cockcroft-Gault formula; CrCl (mL/min) = {(140-age) × body weight (kg)×F}/(SCr (mg/dL) × 72); F=1 in males and F=0.85 in females, and SCr=serum creatinine ii. Urine protein =28g/L; 4) Coagulation function: International normalized ratio (INR) with partial prothrombin time (PTT) or activated partial thromboplastin time (APTT) < = 1.5×ULN; 11. No contraindications to radiotherapy; 12. Female study participants of childbearing potential who have a negative urine or serum pregnancy test result within 3 days prior to the first dose (e.g., urine pregnancy If the pregnancy test result cannot be confirmed to be negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail); 13. If a female study participant of childbearing potential has sexu
Exclusion criteria
Exclusion criteria: 1. Patients with small cell lung cancer ingredients; 2. Presence of distant metastatic disease; 3. Based on clinical, imaging or pathological evaluation, there is malignant pleural effusion or pericardial effusion; 4. Have undergone any systemic or local anti-tumor therapy for NSCLC, including cytotoxic drug therapy, immunodrug therapy, radiotherapy, investigational therapy, biologics, small molecule targeted therapy, etc.; 5. Concurrent enrollment in another clinical study, unless it is a non-interventional clinical study or the follow-up period of an interventional study (defined as the time of first administration more than 4 weeks from the last dose of the previous clinical study or more than 5 half-lives of the investigational drug, whichever is shorter); 6. For the first time, palliative local treatment was performed for non-target lesions; Received non-specific immunomodulatory therapy (such as interleukin, interferon, thymopeptide, tumor necrosis factor, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to the first dose; Have received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before the first dose; Past medical history and comorbidities: 7. Have other malignant tumors other than NSCLC within 3 years before the first dose; Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, carcinoma in situ such as cervix, esophagus, or breast, are allowed to be included; 8. Active autoimmune disease requiring systemic therapy (such as treatment with disease-modifying drugs, corticosteroids, immunosuppressants) within 2 years prior to the first dose (excluding irAEs caused by the use of PD-1/L1 inhibitors). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment; 9. History of major illness within 6 months prior to the first dose, specifically unstable angina, myocardial infarction, congestive heart failure (NYHA classification > of the New York Heart Association) requiring hospitalization within 6 months prior to the first dose = grade 2) or vascular disease (such as aortic aneurysm with risk of rupture), or other cardiac impairment that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial ischemia, etc.); History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistulas, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to the first dose; Any arterial thromboembolic event, venous thromboembolic event of grade 3 or above specified in NCICTCAE5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to the first dose; Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to the first dose; 10. History of gastrointestinal perforation and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea) within 6 months prior to the first dose; 11. Inactivated vaccine is allowed if vaccinated with a live vaccine or live attenuated vaccine within 4 weeks prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year PFS rate as assessed by the investigator based on RECIST v1.1 criteria;Safety: Incidence and severity of adverse events, with pneumonia being the key concern event.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The objective response rate (ORR) after treatment with ivozumab, as evaluated by the researchers using CT (RECIST v1.1) and PET (PERCIST) methodologies;The disease control rate (DCR) after treatment with ivozumab, as evaluated by the researchers using CT (RECIST v1.1) and PET (PERCIST) methods;Median progression-free survival period;Median overall survival;3-year survival rate;Duration of relief; | — |
Countries
China
Contacts
Public ContactMeng Xiangjiao
Shandong First Medical University Affiliated Tumor Hospital (Shandong Provincial Tumor Hospital)
Outcome results
None listed