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Study of Durvalumab for Patients with Limited Stage Small Cell Lung Cancer After Chemoradiotherapy

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What is this study about?

This study focuses on patients with limited stage small cell lung cancer (LS-SCLC) who have already received and responded to platinum-based chemotherapy and radiation therapy (chemoradiotherapy). The treatment being investigated is durvalumab, which is given as a consolidation treatment after the initial chemoradiotherapy has been completed. Consolidation treatment refers to additional therapy given after the main treatment to kill any remaining cancer cells and help prevent the cancer from returning.

The purpose of this study is to describe the safety profile of durvalumab in patients with limited stage small cell lung cancer who have not progressed following chemoradiotherapy. Small cell lung cancer is an aggressive type of lung cancer that tends to grow and spread quickly. Limited stage means the cancer is confined to one side of the chest and can be treated with radiation therapy.

During the study, patients will receive durvalumab for a specific period after completing their chemoradiotherapy. The researchers will monitor patients for side effects, especially those related to the immune system, as durvalumab is a type of immunotherapy that works by helping the immune system recognize and attack cancer cells. They will also track how long patients live without their disease getting worse and their overall survival rate.

1 Enrollment

After signing the informed consent form, you will begin the ALBORAN clinical trial for small cell lung cancer treatment.

Before starting treatment, you will provide blood and tissue samples for biomarker testing. These samples help researchers understand how your body responds to treatment.

2 Starting Durvalumab Treatment

You will receive durvalumab (brand name IMFINZI) as a solution given through an intravenous (IV) infusion. The concentration is 50 mg/mL.

Treatment begins 1-90 days after completing your chemoradiotherapy, assuming your cancer has not progressed.

Durvalumab is given as a maintenance therapy, which means it’s designed to help maintain the benefits achieved from your previous treatment.

3 Treatment Schedule

You will receive durvalumab in cycles. Blood samples will be collected during cycles 1, 2, 3, 4, 7, 10, 13, 19, and 26.

Throughout treatment, your health and cancer status will be monitored regularly.

4 Quality of Life Assessments

During the study, you will complete questionnaires about your quality of life. These include the EORTC QLQ-C30 (a general cancer questionnaire) and QLQ-LC29 (specific to lung cancer).

These questionnaires help researchers understand how the treatment affects your daily life and overall wellbeing.

5 Monitoring for Side Effects

Throughout the trial, you will be monitored for side effects, particularly immune-related adverse events. These are side effects related to how durvalumab affects your immune system.

If you experience significant side effects, your treatment might be delayed, interrupted, or discontinued depending on their severity.

6 Imaging and Disease Assessment

Regular scans will be performed to check if your cancer is stable, shrinking, or growing.

The doctor will use standard criteria called RECIST 1.1 to evaluate these scans and determine how your cancer is responding to treatment.

7 End of Treatment

Treatment will continue until your disease progresses, you experience unacceptable side effects, or you complete the planned treatment duration.

When treatment ends, you will provide final blood samples for research purposes.

8 Follow-up Period

After completing treatment, you will enter a follow-up period where your health and cancer status will continue to be monitored.

The study will track long-term outcomes, including how long you remain without cancer progression and overall survival.

Who Can Join the Study?

  • You must be at least 18 years old
  • You must weigh more than 30 kg (66 pounds)
  • You must be willing to sign an informed consent form before participating in any study procedures
  • You must have limited stage small cell lung cancer (cancer that is confined to one side of the chest and can be treated with radiation therapy)
  • You must have a performance status of 0, 1, or 2 (a measure of how well you can perform daily activities)
  • You must have completed chemotherapy with radiation therapy (chemoradiotherapy) within 1 to 90 days before starting the study drug
  • Your chemotherapy must have included platinum and etoposide medications
  • You must have received appropriate radiation therapy (either standard or hyperfractionated schedules)
  • Your cancer must have responded to treatment or remained stable after chemoradiotherapy
  • You must have adequate organ and bone marrow function, including:
    • Hemoglobin ≥9.0 g/dL (a protein that carries oxygen in your blood)
    • Adequate white blood cell counts (neutrophils ≥1.5 x 10⁹/L)
    • Adequate platelet count ≥100 x 10⁹/L (cells that help blood clot)
    • Acceptable liver function tests
    • Adequate kidney function (creatinine clearance >40 mL/min)
  • You must have a life expectancy of at least 12 weeks

Who Cannot Join the Study?

  • If you have non-small cell lung cancer. This study is specifically for people with small cell lung cancer.
  • If your cancer has spread beyond the original tumor and nearby lymph nodes. This study is for limited-stage small cell lung cancer only.
  • If your cancer has grown or spread during your initial treatment with chemotherapy and radiation.
  • If you have previously received immunotherapy treatments (like durvalumab or similar medications).
  • If you have any active or untreated brain tumors.
  • If you have an autoimmune disease, which is a condition where your immune system attacks your own body.
  • If you have a history of organ transplantation.
  • If you have active infections or uncontrolled medical conditions.
  • If you are pregnant or breastfeeding.
  • If you are currently participating in another clinical trial with an investigational drug.
  • If you have had a major surgery within 4 weeks before starting the study treatment.
  • If you have certain heart conditions like congestive heart failure or poorly controlled high blood pressure.
  • If you have received live vaccines within 30 days before starting the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Jerez de la Frontera Jerez De La Frontera Spain

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Virgen del Rocío University Hospital Sevilla Spain
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario De Cruces Barakaldo Spain
Hcfmgkrk Utkrktzxnyiib Mbdwnyp Du Vxhsvaepwf Santander Spain
Iljprmvp Cdvfud Dhsawluucjsqkqkha L'hospitalet De Llobregat Spain
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Febbupdki Pcna Lx Ijmfhccofjmlv Bjxuhzqre Dqw Hpqmmvtm Uhbrwmcrwbqwf Lz Phm Madrid Spain
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Hkjtngyx Uhkzeufmftehz di A Cvhbzl A Coruna Galicia Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.07.2025

Trial locations

Investigated drugs:

Durvalumab is a medication that works with your immune system to help fight cancer. It belongs to a class of drugs called immune checkpoint inhibitors. Durvalumab helps your immune system recognize and attack cancer cells by blocking a protein called PD-L1, which cancer cells use to hide from immune cells. This medication is being studied as a consolidation treatment, which means it’s given after chemotherapy and radiation to help maintain the treatment response in patients with limited stage small cell lung cancer.

Investigated diseases:

Small Cell Lung Cancer – A form of lung cancer characterized by small, round cells that multiply quickly and form tumors which spread rapidly. Small cell lung cancer typically starts in the bronchi (airways) and can spread to other parts of the body, including lymph nodes, bones, brain, liver, and adrenal glands, often before being detected. The disease progresses aggressively with cancer cells dividing and spreading faster than non-small cell lung cancer. As it advances, symptoms may include persistent cough, chest pain, shortness of breath, wheezing, hoarseness, and recurrent lung infections. Small cell lung cancer is strongly associated with smoking, with the vast majority of cases occurring in people with a history of tobacco use.

Trial ID:
2025-521340-37-00
Protocol code:
D419QL00009
Trial Phase:
Therapeutic confirmatory (Phase III)

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