Non-small cell lung cancer
Conditions
Interventions
Experimental Group:Iparomlimab and Tuvonralimab combined with vinorelbine metronomic chemotherapy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: The subjects voluntarily joined this study and signed the informed consent form, with good compliance and cooperation with follow-up; Male or female patients between the ages of 18-80 years; Patients with locally advanced or metastatic squamous non-small cell lung cancer confirmed by histological or cytological examination, and patients who have progressed on previous anti-PD-1/PD-L1 monoclonal antibody combined with platinum-doublet chemotherapy; (1) Sequential therapy with PD-1/PD-L1 monoclonal antibody and platinum-containing dualization was counted as first-line; (2) Disease progression during the course of standard treatment with adjuvant or neoadjuvant or radical simultaneous or sequential immunoradiotherapy or within 6 months after the last dose is counted as first-line treatment progression; Progression (PD) after at least one treatment after prior anti-PD-1/PD-L1 inhibitor therapy, i.e., at least 3 months of treatment (4 cycles); Life expectancy of at least 3 months; ECOG score: 0-2 points; Must have at least one measurable lesion as defined by RECIST v1.1; (1) If there is only one measurable lesion, if a biopsy is performed on the lesion, at least 14 days after the biopsy is performed, the baseline imaging examination of the lesion can be performed; (2) If the target lesion at the site of previous radiotherapy is the only measurable lesion, the investigator must provide before and after imaging data showing obvious progression of the lesion to confirm the definite progression of the lesion, and it is at least more than 3 months from the end of radiotherapy; Toxicities from prior antineoplastic therapy have recovered to =50%; If the function of major organs is normal, the following criteria are met: (1) The criteria for routine blood examination must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors): 1) HB>=90 g/L; 2)ANC>=1.5×10?/L; 3)PLT>=80×10?/L; (2) Biochemical examination shall meet the following standards: 1) TBIL45 ml/min (Cockcroft-Gault formula); Coagulation function: International normalized ratio (INR) <=1.5, and activated partial thromboplastin time (APTT) <=1.5×ULN; Urine protein<=2 or <1000mg/24h; Patients with asymptomatic or mildly symptomatic brain metastases can be enrolled; Women of childbearing potential must have used reliable contraception or have had a pregnancy test (serum or urine) within 7 days prior to enrollment with a negative result, and be willing to use an appropriate method of contraception during the trial and 6 months after the last dose of the trial drug. For males, they must agree to use an appropriate method of contraception or have been surgically sterilized during the trial and for 6 months after the last dose of the trial drug.
Exclusion criteria
Exclusion criteria: Patients who have previously used vinorelbine; Patients with non-small cell lung cancer other than squamous cell carcinoma of the lung confirmed by histological or cytological examination (including patients with adenocarcinoma or non-small cell lung cancer with adenocarcinoma combined with other types of components); Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery within 4 weeks before the first dose, palliative radiotherapy (but palliative radiotherapy for bone lesions is allowed), small molecule targeted therapy (including small molecule tyrosine kinase inhibitors), modern traditional Chinese medicine preparations approved for anti-tumor treatment by NMPA, and other anti-tumor treatments; Medical history and comorbidities: (1) Patients with obvious symptoms of brain metastases, carcinomatous meningitis, spinal cord compression, or diseases of the brain or leptomeninges found by imaging CT or MRI examination at screening (patients with brain metastases who have completed treatment 14 days before enrollment and have stable symptoms can be enrolled, but they need to be confirmed by cranial MRI, CT or venography evaluation as having no symptoms of cerebral hemorrhage); (2) The patient is participating in other clinical studies or less than 4 weeks from the end of treatment in the previous clinical study; (3) Other active malignancies requiring concurrent treatment; (4) Have a history of malignant tumors. Except for patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ who have received potentially curative therapy and have no disease recurrence within 5 years from the start of treatment; (5) >=3 grade adverse reactions caused by previous anti-PD-1/PD-L1 inhibitor therapy leading to drug discontinuation; (6) Abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT>1.5×ULN), with bleeding tendency or receiving thrombolysis or anticoagulation therapy; Note: Under the premise of the international normalized ratio (INR) of prothrombin time =++, or confirmed 24-hour urine protein volume >=1.0 g; (8) Subjects who have undergone major surgery or have severe trauma have been eliminated for less than 14 days before enrollment; (9) Severe acute or chronic infections requiring systemic treatment; (10) Severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >=450ms for men and >=470ms for women); According to NYHA standards, grade III~IV cardiac insufficiency, or cardiac color ultrasound examination shows that left ventricular ejection fraction (LVEF) =CTCAE 2 degree, except for trauma; (12) Respiratory syndrome (>=CTCAE grade 2 dyspnea), severe pleural effusion, ascites, pericardial effusion; (13) Long-term unhealed wounds or fractures; (14) Decompensated diabetes mellitus or other contraindications to high-dose glucocorticoid therapy; (15) Factors that obviously affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction; (16) Clinically significant hemoptysis (more than 50ml of hemoptysis per day) withi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RP2D;objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival ;disease control rate;overall survival;1 year OS rate;2 year OS rate; | — |
Countries
China
Contacts
Public ContactYang Wei
Sichuan Cancer Hospital
Outcome results
None listed