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A Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer

NCT07103408 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-08-05

No results posted yet for this study

Summary

This study will enroll patients with limited-stage small cell lung cancer (SCLC). Patients will receive chemotherapy (etoposide and platinum-based drugs) combined with dual immune checkpoint blockade (PD-1/CTLA-4) and thymosin alpha 1, with a total cycles of 4. Thoracic radiotherapy was performed no later than the three cycle of chemotherapy. Prophylactic cranial irradiation was recommended for patients who received complete response or partial response after chemoradiotherapy. Finally consolidation therapy with dual immune checkpoint blockade (PD-1/CTLA-4) and thymosin alpha 1 was conducted for one year. The study aims to evaluate the efficacy and safety of this treatment regimen.

Conditions

  • Small-Cell Lung Cancer (SCLC)

Interventions

DRUG

Immuno-chemotherapy

Immuno-chemotherapy regimen included etoposide, cisplatin, iparomlimab and tuvonralimab, and thymosin alpha 1.

RADIATION

Radiotherapy

Definitive dose of thoracic radiotherapy was delivered no later than the three cycle of immuno-chemotherapy. Prophylactic cranial irradiation (PCI) was delivered with a total dose of 25Gy in 10 fractions. PCI was recommended for patients who achieved complete response or partial response after thoracic chemoradiotherapy.

DRUG

Consolidative therapy

Consolidation therapy regimen included iparomlimab and tuvonralimab, and thymosin alpha 1, with a duration of one year.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • China

Study Locations

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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 NCT07103408 on ClinicalTrials.gov