Status:
RECRUITING
Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Haukeland University Hospital
Conditions:
Small-cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 su...
Detailed Description
Studies show that adding ICI therapy to standard chemotherapy prolongs survival in ES SCLC. The survival benefit, however, is modest, and there is a need for more effective therapy. It has been hypoth...
Eligibility Criteria
Inclusion
- Age \> 18 years at time of study entry
- ECOG performance status of 0 or 1
- Body weight \>30 kg
- Adequate bone marrow, liver and kidney function
- Life expectancy of at least 3 months
- At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 30 Gy/10 fractions
- Histologically or cytologically confirmed SCLC
- Stage III-IV disease (TNM v8)
- FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
- 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
- Previous chemo-, immuno- or radiotherapy for SCLC
- Major surgical procedure last 28 days
- History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
- Uncontrolled intercurrent illness
- Other active malignancy
- Leptomeningeal carcinomatosis
- Immunosuppressive medication
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
January 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT05223647
Start Date
January 11 2022
End Date
October 1 2029
Last Update
June 6 2025
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
North Estonia Medical Centre
Tallinn, Estonia
2
Landspitali University Hospital
Reykjavik, Iceland
3
Erasmus MC
Rotterdam, Netherlands
4
Ålesund Hospital
Ålesund, Norway