patients affected by small cell lung cancer (SCLC)
Conditions
Brief summary
overall survival (OS), defined as the time from the date of enrollment registration to the date of death from any cause. Patients still alive at the time of analysis are censored at the last time they are known to be alive.
Detailed description
Toxicity: the assessment of safety will be based mainly on the frequency of adverse events; toxicity will be measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0., Progression Free Survival (PFS) defined as the time from the patient enrollment registration to the evidence of progressive disease, or death, or the last date the patient was known to be progression-free or alive., Objective response rate (ORR): the sum of RECIST v1.1-defined CR and PR out of the number of assessable patients with measurable disease at baseline.
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival (OS), defined as the time from the date of enrollment registration to the date of death from any cause. Patients still alive at the time of analysis are censored at the last time they are known to be alive. | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity: the assessment of safety will be based mainly on the frequency of adverse events; toxicity will be measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0., Progression Free Survival (PFS) defined as the time from the patient enrollment registration to the evidence of progressive disease, or death, or the last date the patient was known to be progression-free or alive., Objective response rate (ORR): the sum of RECIST v1.1-defined CR and PR out of the number of assessable patients with measurable disease at baseline. | — |
Countries
Italy
Outcome results
None listed