A Phase 2 interventional study of Induction Durvalumab +etoposide/platinum +Radiochemotherapy+ durvalumab maintenance in Small Cell Lung Cancer Limited Stage, sponsored by Qian Chu. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Qian Chu · Phase 2, Interventional, and Treatment
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.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's planned enrollment of 100 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Qian Chu is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Drug: Induction 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.
Progression-free survival (PFS)
Defined as the time from first dose of study treatment to date of the first objective disease progression or death from any cause
Time frame: Every 6weeks from the beginning of Cycle 1(each cycle is 42±7days) in induction phase, every 8weeks(each cycle is 56±7days) in first year and every 12weeks in second year in consolidation phase, thereafter every 24weeks until PD or death,up to 3years
Overall survival (OS)
Defined as the time from first dose of study treatment to date of death from any cause.
Time frame: Up to 3 years after the first patient was enrolled. OS rate at 1 year(%), 2 years(%) and 3 years(%) are presented.
Objective response rate (ORR)
Defined as the percentage of patients with at least 1 assessment result of complete response (CR) or partial response (PR) based on all enrolled patients with evaluable disease per RECIST 1.1.
Time frame: up to 3 years
DoR （Duration of response）
Defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response +1).
Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression ,up to 3 years
Number and proportion of patients with adverse events
AE, SAE, AESI, TRAE, imAE will be recorded by Common Terminology Criteria of Adverse Events version 5 \[CTCAE v.5\],number and proportion of patients will be described.
Time frame: Approximately 3 years
Plan to share: No
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