Actively Recruiting
Durvalumab as Consolidation for Patients LS-SCLC
Led by Qian Chu · Updated on 2026-03-27
100
Participants Needed
2
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Durvalumab as Consolidation for Patients LS-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent and follow study requirements
- Histologically or cytologically confirmed small cell lung cancer
- Limited-stage small cell lung cancer (stage I-III, no distant metastasis); stage I or II patients must be medically inoperable
- Age greater than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate normal organ and bone marrow function
- Life expectancy of at least 12 weeks
- At least one measurable lesion not previously treated with radiation, assessed by CT or MRI within 28 days before enrollment
You will not qualify if you...
- Extensive disease small cell lung cancer
- Prior radiotherapy to the chest or chemotherapy for small cell lung cancer
- Previous diagnosis of transformed non-small cell lung cancer or certain mixed histologies except predominant small cell lung cancer
- Unresolved toxicity grade 2 or higher from previous cancer therapy except hair loss, vitiligo, or lab abnormalities
- Concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment (non-cancer hormonal therapy allowed)
- History of allogenic organ transplantation
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness
- History of leptomeningeal carcinomatosis
- Corrected QT interval (QTcF) greater than or equal to 470 ms on ECG
- History of active primary immunodeficiency
- Active hepatitis infection or positive hepatitis B or C markers unless resolved with undetectable viral DNA or RNA
- Receipt of live attenuated vaccine within 30 days before study drug
- Prior participation in a durvalumab clinical trial
- Known allergy or hypersensitivity to durvalumab or any excipient
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
2
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qian Chu, Head of the Thoracic Cancer De
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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