RecruitingPhase 2NCT07055581

Durvalumab as Consolidation for Patients LS-SCLC

A Phase II Study of Durvalumab Combined With EP Prior to Chemoradiotherapy and Followed by Durvalumab as Consolidation for Patients With Limited-stage Small-cell Lung Cancer (CONCUR Study)

Sponsor

Qian Chu

Enrollment

100 participants

Start Date

Feb 24, 2026

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer Limited Stage

Summary

Small-Cell Lung Cancer (SCLC) accounts for 10% to 15% of new lung cancers and is a highly aggressive neuroendocrine tumor. In the past 30 years, the treatment of SCLC has made very limited progress, and basically made breakthroughs in radiotherapy and chemotherapy. With the advent of the immune era, immunotherapy has achieved initial results in the treatment of SCLC. Approximately one-third of patients with small cell lung cancer are in limited-stage (LS-SCLC) disease at first diagnosis. Except for a very small number of patients with T1-2N0 who can be treated with surgery or stereotactic radiation therapy (SBRT), the standard treatment for the rest of the patients with LS-SCLC is concurrent chemoradiotherapy. The ORR of platinum-combined etoposide regimen combined with thoracic radiotherapy in LS-SCLC can reach 70% to 90%, and the median OS is 16-24 months, which significantly improves the survival of patients. Although many measures have been taken in the treatment of LS-SCLC, only 20% of LS-SCLC can be cured, and most patients have relapse and metastasis after treatment. This study is a single arm phase II preliminary pilot study, aim to assess the efficacy and safety of durvalumab combined with EP prior to CRT and followed by durvalumab consolidation therapy for LS-SCLC.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Induction Durvalumab +etoposide/platinum +Radiochemotherapy+ durvalumab maintenance for people with small cell lung cancer limited stage. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

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

DRUGInduction Durvalumab +etoposide/platinum +Radiochemotherapy+ durvalumab maintenance

Drug: Durvalumab Induction Phase: Durvalumab (1500mg D1 IV Q3W) combined with EP \[cisplatin or alternatively Carboplatin (AUC 5-6 D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks\] for minimum two cycles prior to thoracic radiotherapy Consolidation Phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities or for a maximum of 24 months, whichever occurs first. Drug: Chemotherapy Concomitant chemoradiotherapy consists of further four cycles Etoposide (100 mg/m² D1-3), cisplatin (75 mg/m² D1) /carboplatin (AUC 5-6 D1) q3w Radiation: Thoracic Radiotherapy Radiotherapy to the primary tumor is recommended to start with the 3rd cycle of EP, which can be delayed appropriately per investigator's decision. 60±6 Gy, 1.8-2 Gy/d or 45±1.5 Gy (1.5 Gy per fraction twice daily, with 4 hours or more between fractions) or other biologically equivalent regimens will be delivered.