Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTaizhou Hospital
About this trial
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
Eligibility criteria
Qualifiers
Male or female aged ≥ 18 and<80 years old.
The ECOG score is 0-1 points (including 0 and 1 points), and the expected survival period is not less than 3 months.
Confirmed as small cell lung cancer (SCLC) by histopathology or cytology and diagnosed as extensive after systemic evaluation.
I have not received first-line treatment for ES-SCLC systemic chemotherapy or immune checkpoint inhibitors in the past.
Disqualifiers
Mixed small cell lung cancer diagnosed by histology or cytology;
A history of severe allergic diseases, severe drug (including unmarketed investigational drugs) allergies, or known adverse reactions to this medication Allergy to any component of the investigational drug: presence of etoposide, platinum based drugs (carboplatin/cisplatin), or anlotinib.Individuals who are contraindicated to the use of anlotide or Toripalimab;
Previously received treatment with immune checkpoint agonists (such as CD137 agonists) or immune checkpoint inhibitors.Preparation therapy (such as single/dual antibodies against CTLA-4, PD-1, PD-L1, LAG3, etc.) or anti VEGF targeted drugs;
Previously received curative radiotherapy (excluding those who met the inclusion criteria of 5), or before receiving study treatment.Has undergone extensive palliative radiotherapy within 4 weeks, or plans to undergo chest radiotherapy during the study period
Trial design
Treatments tested in this trial
- Toripalimab plus Anlotinib
- Toripalimab
Treatment groups
136 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov