Combining chemotherapy, immunotherapy, and radiotherapy for extensive stage small-cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III clinical trial investigates the effects of combining thoracic radiotherapy with chemotherapy and immune checkpoint inhibitors in patients with extensive stage small-cell lung cancer (ES SCLC). The study aims to determine if administering 30 Gy of radiotherapy concurrently with carboplatin, etoposide, and durvalumab can improve survival outcomes compared to chemotherapy alone. Additionally, the trial will analyze biological materials to identify potential predictive and prognostic biomarkers and assess cognitive function in relation to treatment. Patients will be monitored for brain metastases and cognitive effects throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 years at time of study entry
2. ECOG performance status of 0 or 1
3. Body weight \>30 kg
4. Adequate bone marrow, liver and kidney function
5. Life expectancy of at least 3 months
6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 30 Gy/10 fractions
7. Histologically or cytologically confirmed SCLC
8. Stage III-IV disease (TNM v8)
9. FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
10. Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment

Exclusion Criteria:

1. Previous chemo-, immuno- or radiotherapy for SCLC
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women

Where it's running

• North Estonia Medical Centre
  Tallinn, Estonia Recruiting
• Landspitali University Hospital
  Reykjavík, Iceland Recruiting
• Erasmus MC
  Rotterdam, Netherlands Recruiting
• Haukeland Universitetssykehus
  Bergen, Norway Recruiting
• Nordlandssykehuset HF
  Bodø, Norway Recruiting
• Drammen sykehus - Vestre Viken
  Drammen, Norway Recruiting

Study contacts

• Study coordinator: Bjørn H Grønberg, MD, PhD
• Email: bjorn.h.gronberg@ntnu.no
• Phone: 47297878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.