Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer (TRIPLEX)
Small-cell Lung Cancer
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring cancer, chemotherapy, radiotherapy, immunotherapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Rigshospitalet KøbenhavnRecruiting
- Odense University HospitalRecruiting
- North Estonia Medical CentreRecruiting
- Landspitali University HospitalRecruiting
- Erasmus MCRecruiting
- Haukeland UniversitetssykehusRecruiting
- Nordlandssykehuset HFRecruiting
- Drammen sykehus - Vestre VikenRecruiting
- Innlandet hospital GjøvikRecruiting
- Haugesund hospitalRecruiting
- Sykehuset LevangerRecruiting
- Akershus Universitetssykehus AHUSRecruiting
- Oslo University Hospital UllevålRecruiting
- Stavanger University HospitalRecruiting
- University Hospital of North Norway, Pulmonology DepartmentRecruiting
- Cancer Clinic at St. Olavs HospitalRecruiting
- Ålesund HospitalRecruiting
- Gävle hospitalRecruiting
- Sahlgrenska SjukehusetRecruiting
- Karolinska University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Chemo-immunotherapy plus thoracic radiotherapy
Chemo-immunotherapy
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment. Thoracic radiotherapy of 30 Gy/10 fractions between 2nd and 3rd carboplatin/etoposide/durvalumab course.
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.