RecruitingPhase 2NCT06719700

Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

A Prospective Phase II Study of Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

Sponsor

Sun Yat-sen University

Enrollment

47 participants

Start Date

Nov 30, 2024

Study Type

INTERVENTIONAL

Conditions

Chemoradiotherapy Limited-stage Small Cell Lung Cancer (LS-SCLC)Toripalimab Surufatinib

Summary

Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two new drugs — toripalimab (an immunotherapy) and surufatinib (a targeted anti-cancer drug) — to standard chemotherapy and radiation can improve outcomes for patients with limited-stage small cell lung cancer (a fast-growing lung cancer that has not spread outside the chest). **You may be eligible if...** - You are between 18 and 75 years old - You have small cell lung cancer confirmed by biopsy or lab testing - Your cancer is limited-stage (stage I–III, meaning all tumor areas can be included in one radiation plan) - You are in good physical condition (WHO performance status 0 or 1) - Your expected survival is at least 12 weeks - You are not pregnant and are willing to use contraception during and after treatment **You may NOT be eligible if...** - Your cancer has spread beyond the chest (extensive stage) - You have previously received chemotherapy or radiation for this cancer - You have serious uncontrolled heart, liver, or kidney problems - You have active autoimmune disease - You are pregnant or breastfeeding 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

DRUGChemotherapy

Etoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.

DRUGImmunotherapy

Toripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.

DRUGAngio-immuno kinase inhibitor

Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.

RADIATIONradiotherapy

Thoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.

RADIATIONProphylactic Cranial Irradiation

PCI is recommended after the completion of chemoradiotherapy.

DRUGConsolidation Therapy with Toripalimab and Surufatinib

Patients achieving complete response (CR), partial response (PR), or stable disease (SD) following chemoradiotherapy will receive consolidation therapy. Toripalimab: 240 mg intravenously on day 1, every three weeks. Surufatinib: 200 mg orally on days 1-14, every three weeks.