Locally advanced or metastatic non-small cell lung cancer
Conditions
Interventions
Iparomlimab and Tuvonralimab:Iparomlimab and Tuvonralimab alone,5 mg/kg, Day 1, intravenous injection, 21-day cycle
Sponsors
The first affiliated hostipal of nanchang university
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary signing of the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol; 2.Histologically or cytologically confirmed unresectable stage IIIB-IV metastatic non-small cell lung cancer (NSCLC) (according to the 8th edition of the AJCC TNM staging system); 3.Patients with NSCLC who have not received systemic treatment in the past; 4.Age 18 - 80 years old, gender unrestricted; 5.For patients who have previously received radical neoadjuvant, adjuvant chemotherapy, radiotherapy or chemoradiotherapy for non-metastatic disease, there must be at least a 6-month treatment-free interval from the last chemotherapy, radiotherapy or chemoradiotherapy to the time of enrollment; 6.According to RECIST 1.1 criteria, measurable disease was assessed by the investigator/radiologist. Lesions that had previously received radiotherapy could only be considered measurable if there was clear disease progression at that site since radiotherapy and if the lesion was not the only lesion; 7.Patients with treated and asymptomatic central nervous system metastases are eligible for inclusion (Note: Patients with a single brain metastasis = 30 kg. 10.The expected survival period is >= 12 weeks. 11.Sufficient hematological and organ function as defined by the following laboratory test results obtained within 14 days prior to enrollment: (1) Hemoglobin >= 9.0 g/dL;(2) Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; (3) Platelet count >= 100 × 10^9/L; (4) Serum bilirubin 40 mL/min (calculated by the Cockcroft-Gault formula); (7) International normalized ratio (INR) or activated partial thromboplastin time (aPTT) =50% (TPS>=50%, and PD-L1 detection results of tumor cells obtained within 6 months on the day of signing the informed consent form are acceptable). For patients who have not undergone PD-L1 expression testing previously, archived tumor tissue samples or newly obtained biopsy (core needle biopsy or excisional biopsy) samples from tumor lesions that have not received radiotherapy are requir
Exclusion criteria
Exclusion criteria: 1.Carrying EGFR-sensitive mutations or ALK fusions or ROS1 fusions or MET14 skipping mutations or RET fusions or HER2 mutations or KRAS G12C mutations (Note: EGFR sensitive mutations refer to those that can be treated with tyrosine kinase inhibitors, including osimertinib, erlotinib, gefitinib or afatinib, etc. Subjects with non-squamous histological types will not be included in the study until there are records of EGFR mutation status and/or ALK translocation status and other genetic statuses in the source file; for enrolled subjects with known mainly squamous histological type lung cancer, no genetic mutation molecular testing will be required.); 2.Spinal cord compression that has not been clearly treated through surgery and/or radiotherapy, or spinal cord compression that has been previously diagnosed and treated but there is no evidence that the disease has been clinically stable for more than 2 weeks before enrollment. 3.Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage procedures (once a month or more frequently). 4.Uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L or serum calcium > 12 mg/dL or corrected serum calcium > ULN). 5.There is a history of severe allergy, anaphylactic shock or other hypersensitivity reactions to chimeric antibodies, humanized antibodies or fusion proteins. 6.Currently participating in or having participated in a trial of an investigational drug, or having used an investigational device within 4 weeks prior to the first administration of the investigational treatment. (Note: Subjects who have entered the follow-up stage of an investigational study may participate as long as it has been at least 4 weeks since the last administration of the investigational drug.); 7.Previous receipt of immune-mediated therapy, including but not limited to other anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, but excluding therapeutic cancer vaccines. 8.Patients who received radiotherapy within 2 weeks before the start of the experimental treatment, or who received a lung radiotherapy dose greater than 30 Gy within 6 months before the first administration of the experimental treatment. Patients must have recovered from all radiotherapy-related toxicities, not require corticosteroids, and have no radiation pneumonitis. For palliative radiotherapy for non-central nervous system diseases (<= 2 weeks of radiotherapy), a 1-week washout period is allowed. 9.The non-small cell lung cancer of this patient can be treated with radical radiotherapy and chemotherapy after surgical resection, consultation with the radiotherapy department and MDT discussion. (Note: If the subject has undergone major surgery, they must have fully recovered from the toxicity and/or complications of the surgery before starting the trial treatment.); 10.PD-L1 expression could not be evaluated in the tumor specimen. 11.Patients with known midline brain metastases, untreated central nervous system metastases and/or carcinomatous meningitis are eligible. Patients who have received prior treatment for brain metastases may also participate, but must meet the criteria of radiological stability (i.e., no signs of progression on repeat imaging at least 4 weeks apart [Note: Repeat imaging should be performed during the scr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Progression-free survival 2;The incidence rate of treatment-related adverse events;Duration of response;Treatment Emergency Adverse Event;Overall survival;Disease control rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactWei Zuo
The first affiliated hostipal of nanchang university
Outcome results
None listed