The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for the first-line treatment of extensive-stage small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Benmelstobart injection, 1200 mg/dose, given once every 21 days, intravenously.
Anlotinib hydrochloride capsules, 8 mg/dose, administered orally for 2 consecutive weeks and stopped for 1 week. During the course of the study, subjects may be adjusted upward to a dose of 12 mg if well tolerated, as determined by the investigator, and the dose of anlotinib hydrochloride may be adjusted downward during the course of the study due to drug-related adverse events.
Carboplatin for injection, administered on day 1, AUC 5 mg/mL/min, intravenously (maximal dose used is 750 mg); or cisplatin administered on day 1, 75-80mg/m2, IV.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Progression Free Survival (PFS)
The time from treatment to the first documented progressive disease (PD) assessed by the investigator according to RECIST 1.1 or death for any reason. Evaluated every 2 cycles/6 weeks on treatment and every 3 months in follow-up.
Time frame: Approximately 7 months from treatment.
Overall Survival (OS)
The time from treatment to death due to any cause. Follow-up visits were made every 3 months after the end of treatment.
Time frame: Approximately 14 months from treatment.
Objective Response Rate (ORR)
Percentage of participants who achieved Complete Response (CR) or Partial Response (PR), assessed by the investigator according to RECIST 1.1.
Time frame: Approximately 12 weeks after the last participant begin study treatment.
Duration of Response (DOR)
The time from the first response (Complete Response (CR) or Partial Response (PR)) to disease progression (PD) assessed by the investigator according to RECIST 1.1 or death for any reason.
Time frame: Approximately 7 months from treatment.
Disease Control Rate (DCR)
Percentage of participants who achieved Complete Response (CR), Partial Response (PR) or Stable Disease (SD), assessed by the investigator according to RECIST 1.1.
Time frame: Approximately 12 weeks after the last participant begin study treatment.
Safety (Adverse Events (AEs))
Type and severity of adverse events according to CTCAE v5.0; calculation of the incidence of adverse events and their incidence by system.
Time frame: From enrollment until 30 days after the end of treatment.
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Etoposide injection, 100mg/m2 on days 1, 2 and 3, IV.