RecruitingPhase 2NCT05765825

Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC

Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer

Sponsor

Sichuan University

Enrollment

61 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Extensive-stage Small-cell Lung Cancer

Summary

This is a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding low-dose radiation to standard chemotherapy plus immunotherapy (serplulimab) improves outcomes for patients with extensive-stage small cell lung cancer (ES-SCLC) — a fast-growing type of lung cancer that has spread beyond the chest. **You may be eligible if...** - You have been confirmed to have ES-SCLC by biopsy or lab test - You have not received any prior treatment for ES-SCLC - You have at least one measurable tumor on scans - You are in good overall health (ECOG 0 or 1) - You have a life expectancy of at least 3 months - Your HIV, hepatitis B, and hepatitis C tests are negative **You may NOT be eligible if...** - You have already received treatment for small cell lung cancer - You have poor overall health or organ function - You have active hepatitis or HIV infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGserplulimab

Serplulimab will be administered by intravenous infusion at a dose of 4.5mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, and clinical status.

DRUGCisplatin

Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (75 mg/m\^2) after completion of serplulimab on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

DRUGCarboplatin

Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) of 5 mg/mL/min on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

DRUGEtoposide

Etoposide will be administered intravenously at a dose of 100 mg/m\^2 on Days 1, 2 and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

RADIATIONThoracic radiation therapy (TRT)

Participants will receive concurrent low-dose radiotherapy treatment, in once daily fractions, 3 Gy per fraction, to a target dose of 15 Gy in 5 fractions from Day 1-Day 5 in the first cycle, third cycle（ For patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor shrinkage \< 80%)/SD/PD），forth cycle（for subjects evaluated as PD/SD/PR with extrathoracic residual metastases).