ECOG PS 0-1 and older than 70 or did not receive a concomitant thoracic CRT because of comorbidities) previously untreated, Histologically confirmed frail Limited Disease Small Cell Lung Cancer (ECOG PS 2
Conditions
Brief summary
PFS is defined by investigator as the time from inclusion until disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Detailed description
Overall Survival (OS) is defined as the time from inclusion to death due to any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date., Safety profile: occurrence of adverse events coded using NCI CTC-AE version 5.0., Quality of life (QL) will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) core QL questionnaire, the EORTC QLQ-C30 and LC13 questionnaires (Lung Cancer Module).
Interventions
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
Sponsors
Unicancer
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS is defined by investigator as the time from inclusion until disease progression (per RECIST v1.1) or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) is defined as the time from inclusion to death due to any cause. Patients still alive at the time of analysis (including lost to follow-up) will be censored at the last known alive date., Safety profile: occurrence of adverse events coded using NCI CTC-AE version 5.0., Quality of life (QL) will be assessed by the European Organization for Research and Treatment of Cancer (EORTC) core QL questionnaire, the EORTC QLQ-C30 and LC13 questionnaires (Lung Cancer Module). | — |
Countries
France
Outcome results
None listed