A total of 66 patients were enrolled in this exploratory study and randomly assigned to cohort 1 and cohort 2, with 33 patients in each group. Cohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle). Cohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle). Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) .
Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Aged 18 to 75 years (inclusive) at the time of signing informed consent, regardless of gender.
Histologically confirmed small cell lung cancer (SCLC).
Confirmed as stage I-IIIB SCLC (T1-3N0-2M0) per AJCC 9th Edition.
Histologically confirmed mixed-type SCLC.
Extensive-stage SCLC.
ECOG PS >1.
Active or untreated CNS metastases confirmed by CT/MRI during screening/prior imaging.
Parallel
benmelstobart combined with chemotherapy and anlotinib
DrugCohort 1: Neoadjuvant therapy (benmelstobart combined with chemotherapy and anlotinib, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day 1. Anlotinib, 10 mg, po, qd, was taken orally for 2 consecutive weeks and stopped for 1 week. Anlotinib was stopped 1 week before surgery. Etoposide, 100mg/m2, day 1\~3. Cisplatin, 75mg/m2，day 1; or Carboplatin, AUC 5, day 1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart combined with anlotinib, 12 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; anlotinib, 10 mg, po, qd, was taken orally for 2 weeks and stopped for 1 week.
benmelstobart combined with chemotherapy
DrugCohort 2: Neoadjuvant therapy (benmelstobart combined with chemotherapy, 3 cycles, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1; Etoposide, 100mg/m2, day 1\~3; Cisplatin, 75mg/m2，day 1; or Carboplatin, AUC 5, day 1. Surgery was performed 4-6 weeks after the final administration of benmelstobart as assessed by the investigator. Adjuvant therapy was evaluated by the investigator 4-6 weeks after surgery. Patients who achieved R0 resection received adjuvant therapy (benmelstobart, every 21 days is a cycle) : benmelstobart, 1200mg, iv, day1.
event-free survival (EFS)
The event-free survival (EFS) is defined as the duration from randomization to the occurrence of any event, which includes disease progression, postoperative recurrence, discontinuation of treatment for any reason, or death.
Major pathologic response rate (MPR)
Major pathologic response rate (MPR) as assessed/estimated by the investigator, i.e. the proportion of residual surviving tumor cells in the tumor bed in the postoperative specimen ≤10%
Complete pathological response (pCR)
Complete pathological response (pCR): defined as no residual tumor cells in postoperative tumor tissue specimens (including no tumor residue in lymph nodes), based on pathological response
Objective response rate (ORR)
The proportion of patients who exhibit a partial response (PR) or complete response (CR) to treatment is defined as follows.
overall survival (OS)
Overall survival (OS) refers to the duration from the initiation of randomization until death occurs for any reason.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
