This is a prospective, single-arm clinical study to evaluate the efficacy and safety of etoposide in combination with bemosubezumab and sequential Benmelstobart in combination with Anlotinib as first-line treatment for elderly patients with extensive small-cell lung cancer.
Participants who met the inclusion criteria were selected to enter the study and received etoposide combined with Benmelstobart followed by bemosubezumab combined with Anlotinib. The primary endpoint was PFS (Progression-free Survival), the secondary endpoint was OS (Overall Survival) and safety (CTCAE 5.0), and the exploratory endpoint was the screening of various potential molecular markers.
Patients with pathologically proven extensive small-cell Lung cancer (according to the Veterans Administration Lung Study Group, VALG stage) who have not previously received systematic treatment for extensive small-cell lung cancer;
Patients who have previously received chemoradiotherapy for limited-stage SCLC must have received radical therapy and have at least 6 months of treatment-free intervals between the end of chemotherapy, radiotherapy, or chemoradiotherapy and the diagnosis of extensive SCLC (end time of last chemotherapy cycle/end time of last radiotherapy).
There was no gender limitation. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good
ECOG score: 0-2;
Used antiangiogenic drugs or related immunotherapy drugs such as PD-1 and PD-L1 in the past;
Subjects with known central nervous system metastatic and/or cancerous meningitis; (Unless asymptomatic, or treated and stable, no radiographic evidence of new BMS or enlarged BMS was found at least 2 weeks after BMS treatment, and steroid or anticonvulsant therapy was discontinued for at least 14 days before study therapy began. If active or new untreated, asymptomatic CNS metastases are found on imaging in subjects during the screening period, radiation therapy or untreated imaging evidence of new or enlarged BMS is required for at least 2 weeks.)
Subject has had or co-developed other malignancies (except cured basal cell carcinoma of the skin and cervical carcinoma in situ) within 5 years;
Subject has multiple factors that affect oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);