CTTQ
Status and phase
Conditions
Treatments
About
This is a randomized, controlled, open-label, multicenter clinical study to evaluate the efficacy and safety of carboplatin/cisplatin + etoposide + benmelstobart sequential benmelstobart combined with anlotinib versus carboplatin/cisplatin + etoposide + Tislelizumab sequential Tislelizumab in the first-line treatment of extensive stage small cell lung cancer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
18 years old ≤age≤ 75 years old (calculated on the date of signing the informed consent);
Eastern Cooperative Oncology Group (ECOG) score 0 ~ 1;
Expected survival greater than 12 weeks.
Histologically or cytologically confirmed Extensive stage small cell lung cancer (ES-SCLC) (according to the Veterans Administration Lung Cancer Society (VALG) disease staging system).
had not received systemic therapy for ES-SCLC (including systemic chemotherapy, molecular targeted drug therapy, biological therapy and other investigational therapeutic drugs, etc.) or immune checkpoint inhibitor therapy.
Patients receiving chemoradiotherapy for previously limited-stage SCLC must be treated for cure, and there must be a treatment-free interval of at least 6 months from the last course of chemotherapy, radiotherapy, or chemoradiotherapy to the diagnosis of extensive SCLC.
Confirmed presence of at least one measurable lesion according to RECIST 1.1 criteria. Note: Measurable target lesions cannot be selected from previous radiotherapy sites. If the target lesion of the previous radiotherapy site is the only alternative target lesion, the investigator should provide pre - and post-imaging data showing significant progression of the lesion.
Laboratory inspection meets the following standards:
Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.
Exclusion criteria
Had or was currently suffering from other malignant tumors within 3 years prior to the first medication. The following two conditions can be included: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta(non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)].
The presence of diseases affecting intravenous administration, intravenous blood collection, or multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
The adverse effects of previous treatment did not return to The Common Terminology Criteria for Adverse Events (CTCAE) v5.0 score ≤ 1, except for grade 2 alopecia, grade 2 peripheral neurotoxicity, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, stable hypothyroidism after hormone replacement therapy and other toxicities deemed by the investigators to be of no safety risk.
Those who have received major surgical treatment, significant traumatic injury, or major surgery during the intended study treatment period (other than protocol-specified surgery) within the 4 weeks prior to initial medication, or have sustained unhealed wounds or fractures. (Major surgery is defined as surgery at grade 3 and above in the National Surgical Grading Directory 2022 edition).
Subjects with any bleeding or bleeding event ≥ CTC AE grade 3 within 4 weeks prior to initial dosing.
Patients who experienced a hyperarterial/venous thrombosis event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before the first administration of the drug.
Active viral hepatitis and poorly controlled. Those who meet the following requirements can be screened: HBsAg positive subjects must meet Hepatitis B virus (HBV) DNA quantification <2000 IU/ml (or 1*104 copy/ml) or receive anti-HBV therapy with a 10-fold (1 log) or greater reduction in viral index for at least 1 week prior to study initiation, and subjects are willing to receive anti-HBV therapy throughout the study period; HCV infected persons (HCV Ab or HCV RNA positive) : The investigators judged to be in a stable state or were receiving antiviral therapy at enrollment and continued to receive approved antiviral therapy in the study.
Patients with active syphilis who need treatment;
There is a history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or active pneumonia with clinical symptoms.
Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
People who are preparing for or have previously received allogeneic bone marrow transplantation or solid organ transplantation.
History of hepatic encephalopathy.
Major cardiovascular disease, including any of the following:
Active or uncontrolled severe infection (≥CTC AE grade 2 infection);
Patients with renal failure requiring hemodialysis or peritoneal dialysis;
Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases;
Subjects who require immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and who continue to use it for 7 days prior to initial administration (except for corticosteroids < 10 mg daily prednisone or other therapeutic hormones);
People who have epilepsy and need treatment.
Tumor-related symptoms and treatment:
Known allergy to study drug excipients, known severe allergic reaction to any monoclonal antibody, history of carboplatin, cisplatin, or etoposide allergy.
Subjects had previously been treated with other antibodies/drugs targeting immune checkpoints, such as PD-1, PD-L1, CTLA4, etc.
Previously received treatment with anti-angiogenic drugs such as Anlotinib, Apatinib, and Bevacizumab.
Participants who had participated in and used other anti-tumor clinical trials within 4 weeks before the first medication.
In the judgment of the investigator, there is a situation that seriously endangers the safety of the subject or affects the completion of the study.
Primary purpose
Allocation
Interventional model
Masking
134 participants in 2 patient groups
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Central trial contact
Jie Wang, Doctor; Dongqing Lv, Master
Data sourced from clinicaltrials.gov
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