NCT06441344

Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell

First-line Etoposide Combined With Platinum-based Chemotherapy Followed by Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell Carcinoma - A Randomized, Controlled, Multicenter Phase III Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Taizhou Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open, multicenter Phase III clinical study. A total of 136 participants are planned to be enrolled and randomly assigned to either the experimental group (platinum+etoposide → toripalimab plus anlotinib) or the control group (platinum+etoposide+ toripalimab → toripalimab) in a 1:1 ratio. The primary efficacy measures include PFS, while secondary endpoints include OS, DOR, ORR, DCR, progression free survival at 6 and 12 months, overall survival at 12 and 18 months, health-related quality of life (FACT-L), safety, etc. And in the III clinical study, tissue samples were collected before treatment, and tumor tissue and blood samples were taken from some patients after 3 cycles of maintenance treatment and treatment progression for single-cell sequencing and transcriptome sequencing to verify the underlying mechanism research

Detailed description

This study plans to enroll 136 subjects and randomly allocate them in a 1:1 ratio to the experimental group (platinum+etoposide → toripalimab plus anlotinib) and the control group (platinum+etoposide+ toripalimab → toripalimab). The experimental group was given etoposide (100 mg/m2) d1-3+carboplatin (AUC 5 d1)/cisplatin (25 mg/m2 D1-3) chemotherapy regimen, for patients who have received 4-6 cycles chemotherapy sessions (including PR, CR, SD), they will enter the maintenance treatment phase and receive an oral dose of 12 mg of anlotinib ( on days 1-14) combined with 240 mg toripalimab for maintenance treatment; The control group was given etoposide (100 mg/m2) d1-3+carboplatin (AUC 5) d1/cisplatin (25mg/m2) d1+toripalimab 240 mg d1 (including PR, CR, SD) who have been treated 4-6 cycles will enter the maintenance treatment period, and receive maintenance treatment with toripalimab 240 mg d1 . The above treatment regimen lasts for 21 days per cycle until disease progression or Intolerable adverse reactions occur or researchers believe that patients are not suitable for continued medication. After the subject terminates or withdraws from this study, the researcher may adopt reasonable follow-up treatment based on the subject's condition. All patients will be followed up until death or the deadline for data collection. Collect pathological tissue samples before treatment for genetic testing. Before using maintenance therapy medication, after 1 cycle of maintenance therapy and during progression, after 3 cycles of treatment, some patients are selected for puncture biopsy sampling after treatment progression Perform sequencing and biomarker inspection. Follow up on PFS, OS, ORR, DCR, adverse reactions, etc. in two groups of patients. Before maintenance therapy, researchers are allowed to perform local radiotherapy based on the patient's actual situation, such as cranial radiotherapy, bone metastasis radiotherapy, etc., but radiotherapy for the target lesion is not allowed. However, additional treatments related to tumors, including traditional Chinese medicine and radiation therapy, are not allowed during the maintenance treatment process. The primary endpoints of this study were objective progression free survival (PFS) and overall survival (OS) evaluated according to the RECIST v1.1 criteria, while secondary endpoints were duration of response (DOR), overall objective response rate (ORR), disease control rate (DCR)and safety.

Conditions

• SCLC
• Maintenance Treatment

Interventions

Type	Name	Description
DRUG	Toripalimab plus Anlotinib	For patients who did not progress after standard chemotherapy, toripalimab plus anlotinib maintenance therapy was used
DRUG	Toripalimab	For patients who did not progress after standard chemotherapy+toripalimab, toripalimab maintenance therapy was used

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-05-01
• Completion: 2030-05-01
• First posted: 2024-06-04
• Last updated: 2024-06-04