Actively Recruiting
Durvalumab Combined With Chemotherapy and Radiotherapy Followed by Durvalumab Consolidation for Limited-stage Small-cell Lung Cancer
Led by Qian Chu · Updated on 2026-03-27
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Small-cell lung cancer (SCLC) is a fast-growing neuroendocrine tumor that accounts for 10% to 15% of new lung cancer cases. Limited-stage SCLC (LS-SCLC) is diagnosed in about one-third of patients, with standard treatment involving concurrent chemoradiotherapy. Despite advances, only about 20% of patients with LS-SCLC are cured, and relapse or metastasis are common. This phase II pilot study aims to evaluate the safety and effectiveness of combining durvalumab with chemotherapy and radiotherapy followed by durvalumab consolidation therapy for LS-SCLC patients. The treatment involves an induction phase where durvalumab is combined with etoposide and platinum-based chemotherapy (cisplatin or carboplatin) before thoracic radiotherapy. Following this, patients receive durvalumab consolidation therapy every four weeks for up to 24 months or until disease progression or unacceptable side effects. Radiotherapy to the tumor begins around the third cycle of chemotherapy and is given in specific doses over several days. This is a single-arm, multi-center study focused on this combined treatment approach. Participants will be monitored regularly with imaging scans to assess progression-free survival every 6 weeks during induction and at longer intervals during consolidation, for up to 3 years. Researchers will also track overall survival, response rates, duration of response, and adverse events over approximately 3 years. This comprehensive follow-up includes laboratory tests and clinical evaluations to carefully assess treatment outcomes and safety throughout the study period.
CONDITIONS
Brief Title
Durvalumab as Consolidation for Patients LS-SCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Histologically or cytologically confirmed small cell lung cancer
- Limited-stage disease (stage I to III) with no distant metastasis
- Patients with stage I or II who cannot have surgery
- Age over 18 years
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function
- Life expectancy of at least 12 weeks
- At least one measurable tumor lesion not previously treated with radiation
You will not qualify if you...
- Extensive-stage small cell lung cancer
- Previous chemotherapy or thoracic radiotherapy for small cell lung cancer
- History of non-small cell lung cancer or mixed histology except predominant SCLC
- Unresolved grade 2 or higher toxicity from prior cancer treatment except hair loss or lab abnormalities
- Concurrent chemotherapy, biologic, or hormonal cancer treatment other than study drugs
- History of organ transplantation
- Active or past autoimmune or inflammatory disorders
- Uncontrolled illness
- History of leptomeningeal carcinomatosis
- Abnormal heart rhythm with QTcF over 470 ms
- History of active primary immunodeficiency
- Active hepatitis infection or positive viral markers unless resolved and undetectable
- Live vaccine within 30 days before study drug
- Prior participation in durvalumab trials
- Allergy to study drug or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or unacceptable toxicities
Participants receive induction treatment with durvalumab combined with chemotherapy and radiotherapy, followed by durvalumab consolidation until disease progression, unacceptable toxicities, or up to 24 months.
Visits every 3 weeks during induction phase; then every 4 weeks during consolidation phase
Duration - Up to 3 years after treatment start
Participants are monitored for progression-free survival, overall survival, and adverse events up to 3 years after treatment begins.
Visits every 6 weeks during induction, every 8 weeks in first year of consolidation, every 12 weeks in second year, and every 24 weeks thereafter until progression or death
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
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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