Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer

• Status: Recruiting
• Trial end date: 2029-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Studies have shown that combining chemotherapy and immune checkpoint inhibitors (ICI) prolongs survival compared with chemotherapy alone in extensive stage small-cell lung cancer (ES SCLC), but the survival benefit is modest. The main aim of this trial is to investigate whether there is a synergistic/additive effect of concurrent thoracic radiotherapy in ES SCLC patients receiving carboplatin/etoposide/durvalumab.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Norwegian University of Science and Technology
• Collaborators: Alesund Hospital; Drammen sykehus; Erasmus Medical Center; Gävle Hospital; Haukeland University Hospital; Helse Fonna; Helse Nord-Trøndelag HF; Helse Stavanger HF; Karolinska University Hospital; National Cancer Institute, Lithuania; North Estonia Medical Centre; Odense University Hospital; Oslo University Hospital; Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden; St. Olavs Hospital; Sykehuset Innlandet HF; University Hospital of North Norway; University Hospital, Akershus
• Treatments: Carboplatin; Durvalumab; Etoposide

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