RecruitingPhase 2NCT06223711

Durvalumab With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Oligometastatic ES-SCLC

Durvalumab (MEDI4736) in Combination With Consolidative Radiochemotherapy and Ablative Stereotactic Radiotherapy in Extensive Stage SCLC


Sponsor

Universität des Saarlandes

Enrollment

43 participants

Start Date

Oct 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Open-label, single-arm, prospective multicenter phase II clinical trial to determine the efficacy of immunotherapy with durvalumab concomitant with radiochemotherapy, followed by durvalumab maintenance therapy in combination with stereotactic radiotherapy in extensive stage SCLC


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted radiation therapy (to all cancer sites, not just the chest) to the immunotherapy drug durvalumab can improve outcomes in people with small cell lung cancer (SCLC) that has spread to only a few locations in the body (oligometastatic disease) and responded to initial chemotherapy. **You may be eligible if...** - You have been newly diagnosed with extensive-stage small cell lung cancer that has spread to up to four separate tumor sites - Your cancer has responded to (or stabilized with) two initial rounds of chemotherapy combined with durvalumab - Your lung function is adequate (FEV1 at least 1.3 liters) - Your blood counts, liver, and kidney function are adequate - Your overall health is acceptable (ECOG 0–1) **You may NOT be eligible if...** - You have had other prior cancer treatments besides the initial two rounds of chemotherapy and durvalumab - You have an active autoimmune disease - You have active hepatitis B, C, or HIV - You have had a recent major surgery within 4 weeks - You are pregnant or breastfeeding - You have leptomeningeal disease (cancer spread to the lining of the brain and spinal cord) Talk to your doctor to see if this trial is right for you.

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

RADIATIONThoracic Radiochemotherapy

Radiotherapy to the primary tumor including mediastinal lymph node metastases is delivered in single fractions of 1.8Gy once daily up to a cumulative dose of 63.0Gy by intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT).

DRUGdurvalumab

Durvalumab is administered in fixed dose 1500mg in q3w cycles concomitant to chemotherapy and q4w cycles during maintenance treatment

RADIATIONStereotactic radiotherapy of further tumor locations

Stereotactic radiotherapy is delivered to the up to four further tumor locations during durvalumab maintenance therapy and will be performed according to local standards with established dose and fractionation schemes in ablative doses depending on the affected organ system.

DRUGChemotherapy

Concomitant chemotherapy consists of further two cycles platinum/etoposide q3w (summarized cycle 3-4).


Locations(5)

University Hospital Augsburg, Radiation Oncology

Augsburg, Bavaria, Germany

University Hospital Erlangen, Radiation Oncology

Erlangen, Bavaria, Germany

University Hospital Regensburg, Clinic and Polyclinic for Radiotherapy

Regensburg, Bavaria, Germany

Kliniken Maria Hilf

Mönchengladbach, North Rhine-Westphalia, Germany

Saarland University Medical Center and Saarland University Faculty of Medicine, Clinic for Radiotherapy and Radiooncology

Homburg, Saarland, Germany

View Full Details on ClinicalTrials.gov

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NCT06223711


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