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Sintilimab Plus Anlotinib as Second or Further-line Therapy for ES-SCLC Who Have Progressed After Anti-PD-1/L1 Therapy

NCT07022301 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-06-15

No results posted yet for this study

Summary

The phase II study enrolled ES-SCLC patients who had disease progression after anti-PD-1/L1 therapy. Participants received intravenous sintilimab 200 mg on day one and oral daily anlotinib 8-12 mg on days 1-14 once every three weeks per cycle. The primary endpoint was objective response rate (ORR). The secondary endpoints included overall survival (OS), progression-free survival (PFS) , disease control rate (DCR) and safety.

Conditions

  • Small Cell Lung Cancer Extensive Stage
  • Resistance to Immunotherapy

Interventions

DRUG

sintilimab combined with anlotinib

Patients who met the inclusion criteria were treated with Sintilimab plus anlotinib every 3 weeks until disease progression or intolerable adverse reactions or death(up to 24 months).

Sponsors & Collaborators

  • First Affiliated Hospital of Wannan Medical College

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2027-05-31
Completion
2029-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022301 on ClinicalTrials.gov