Lung cancer
Conditions
Interventions
Combination therapy group:the combination antibody of Iparomlimab and Tuvonralimab at a dose of 5 mg/kg is administered intravenously once every three weeks, in combination with Anlotinib taken orally
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate, and signed the informed consent form (ICF), and are able to comply with the study process; 2. Age >=18 years old at the time of enrollment, both male and female; 3. Histologically or cytologically confirmed III-IV small cell lung cancer (staging according to Veterans Administration Lung Study Group, VALG) of the American Veterans Lung Cancer Association, and disease progression after prior treatment with first-line or more systemic chemotherapy (with or without PD-1/PD-L1 antibody); 4. ECOG physical fitness score of 0~1 points; 5. Estimated survival time>=12 weeks; 6. Presence of measurable lesions as defined by RECIST v 1.1 criteria: the lesion can only be considered measurable when the previous irradiated lesion has a definite disease progression after radiotherapy, and the previous lesion is not the only lesion; 7. Adequate organ function prior to the first dose of study treatment (no use of any blood components, leukocyte-raising drugs, platelet-raising drugs is allowed within 14 days prior to the first dose of study treatment): (1) White blood cell count>=3.0×10^9/L; Absolute neutrophil count>=1.5×10^9/L; platelets>=80×10^9/L; hemoglobin >=9 g/dL; (2) Serum albumin>=3g/dL; (3) Thyroid-stimulating hormone (TSH) =60mL/min (standard Cockcroft-Gault formula applied); Urinalysis showed a urine protein <2; For patients with urine protein 2 on urine routine at baseline, 24-hour urine collection should be performed and 24-hour urine protein quantification should be <1 g; (6) Coagulation function test: international normalized ratio (INR) <=2 or prothrombin time (PT) exceeds the upper limit of the normal range <=6 seconds; 8. Subjects (including females and males) agree to use effective contraception from the time of signing the ICF until the last use of the trial drug until 180 days after the last use of the trial drug. Female patients of childbearing potential must have a negative blood or urine pregnancy test within 14 days prior to enrollment; Women who are not pregnant or lactating within 6 months from the signing of informed consent to the last use of the trial drug (if they agree to stop breastfeeding during this period, they can be included).
Exclusion criteria
Exclusion criteria: 1. Prior treatment with anlotinib or anti-CTLA-4/anti-PD-1 combination antibody; 2. Presence of active central nervous system metastases; 3. The imaging during the screening period shows that the tumor invades the large blood vessels or has obvious necrosis and cavitation, and the investigator judges that there may be a high risk of bleeding; 4. Clinically symptomatic third space effusion requiring repeated drainage (e.g., less than once every 4 weeks), such as pericardial effusion, pleural effusion and ascites effusion that cannot be controlled by pumping or other treatments; 5. Other malignant tumors complicated by 10 mg/day prednisone or equivalent) or other immunosuppressants within =14 days prior to the first dose of study drug; 7. Have a history of idiopathic pulmonary fibrosis, organizing pneumonitis (such as bronchiolitis obliterans), drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or clinically symptomatic active pneumonitis; or other moderate to severe lung disease that significantly affects lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area can participate in this study); 8. Subjects with active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within 48 weeks = prior to screening, regardless of treatment; 9. Evidence of active viral, bacterial, or systemic fungal infection requiring intravenous therapy within 7 days prior to initiation of study drug treatment; 10. Have serious cardiovascular diseases, such as New York Heart Association grade 2 or above heart failure, unstable angina, unstable arrhythmia, uncontrolled hypertension, myocardial infarction or cerebrovascular accident that occurred within 6 months before the screening period; 11. Received Chinese patent medicines or immunomodulatory drugs with anti-tumor indications (including but not limited to thymus peptide, interferon, interleukin, etc.) within 2 weeks before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Overall Survival (OS);Disease Control Rate (DCR);Adverse Events (AEs) ; | — |
Countries
China
Contacts
Public ContactWang Pingli
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed