Health TrialsbyHealthPanel

Toripalimab Plus Anlotinib for the Maintenance of Extensive Stage Small Cell

ConditionsSCLCMaintenance Treatment
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Toripalimab plus Anlotinib

    Drug

    For patients who did not progress after standard chemotherapy, toripalimab plus anlotinib maintenance therapy was used

  • Toripalimab

    Drug

    For patients who did not progress after standard chemotherapy+toripalimab, toripalimab maintenance therapy was used

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: platinum+etoposide → toripalimab plus anlotinibExperimental treatment 1 intervention
Group B: platinum+etoposide+ toripalimab → toripalimabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

progression free survival(PFS)

The time from the start of randomization until the first occurrence of disease. progression or death from any cause, whichever occurs first.

Time frame
5 years from first patient randomized
2

overal survival time(OS)

The time from randomization to death from any cause

Time frame
5 years from first patient randomized

Secondary outcomes

1

Adverse events

The type, frequency, severity, and degree of treatment-related adverse events (according to CTCAE version 5.0)

Time frame
Duration of time from the start of treatment to the end of study, assessed up to 5 years
2

objective response rate(ORR)

The proportion of patients with a complete or partial response

Time frame
Duration of time from the start of treatment to the end of study, assessed up to 5 years
3

Disease control rate(DCR)

the proportion of patients with a complete response, partial response, or stable disease

Time frame
Duration of time from the start of treatment to the end of study, assessed up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taizhou Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: