Non-small cell lung cancer (Stage IV)
Conditions
Brief summary
The primary objective is to evaluate the acute toxicity (<3 months) and subacute toxicity (3-6 months) toxicity) of immunotherapy combined with extensive radiotherapy in patients with stage IV NSCLC compared with immunotherapy without radiotherapy.
Detailed description
Adverse events and laboratory values will be graded according to the NCI-CTCAE version 5.0. and published, Response will be evaluated by iRECIST 1.1 and RECIST 1.1. Survival data (PFS and OS) and response rates (RR and DOR) will be evaluated and published., HRQoL will be evaluated at baseline, end of radiotherapy and at 3 and 6 months for both study arms and published.
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
Sponsors
Oslo University Hospital HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate the acute toxicity (<3 months) and subacute toxicity (3-6 months) toxicity) of immunotherapy combined with extensive radiotherapy in patients with stage IV NSCLC compared with immunotherapy without radiotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events and laboratory values will be graded according to the NCI-CTCAE version 5.0. and published, Response will be evaluated by iRECIST 1.1 and RECIST 1.1. Survival data (PFS and OS) and response rates (RR and DOR) will be evaluated and published., HRQoL will be evaluated at baseline, end of radiotherapy and at 3 and 6 months for both study arms and published. | — |
Countries
Norway
Outcome results
None listed