Combining chemotherapy, immunotherapy, and radiotherapy for extensive stage small-cell lung cancer
Randomized Phase III Trial Investigating the Survival Benefit of Adding Thoracic Radiotherapy to Durvalumab (MEDI4736) Immunotherapy Plus Chemotherapy in Extensive Stage Small-cell Lung Cancer
This study is testing if combining radiation therapy with chemotherapy and immunotherapy can help people with advanced small-cell lung cancer live longer and stay healthier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Norwegian University of Science and Technology Academic / other |
| Drugs / interventions | durvalumab, chemotherapy |
| Locations | 20 sites (Tallinn and 19 other locations) |
| Trial ID | NCT05223647 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed extensive stage small-cell lung cancer and adequate organ function.
Not a fit: Patients with previous treatments for small-cell lung cancer or those with uncontrolled intercurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for patients with extensive stage small-cell lung cancer.
How similar studies have performed: Other studies have shown modest success with similar combinations of chemotherapy and immunotherapy, but this specific approach with concurrent radiotherapy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tallinn and 19 other locations
- 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)
- Innlandet hospital Gjøvik — Gjøvik, Norway (Recruiting)
- Haugesund hospital — Haugesund, Norway (Recruiting)
- Sykehuset Levanger — Levanger, Norway (Recruiting)
- Akershus Universitetssykehus AHUS — Oslo, Norway (Recruiting)
- Oslo University Hospital Ullevål — Oslo, Norway (Recruiting)
- Stavanger University Hospital — Stavanger, Norway (Recruiting)
- University Hospital of North Norway, Pulmonology Department — Tromsø, Norway (Recruiting)
- Cancer Clinic at St. Olavs Hospital — Trondheim, Norway (Recruiting)
- Ålesund Hospital — Ålesund, Norway (Recruiting)
- Gävle hospital — Gävle, Sweden (Recruiting)
- Sahlgrenska Sjukehuset — Göteborg, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Lund University Hospital — Skåne, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
Study contacts
- Study coordinator: Bjørn H Grønberg, MD, PhD
- Email: bjorn.h.gronberg@ntnu.no
- Phone: 47297878
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.