extensive-stage small cell lung cancer
Conditions
Interventions
Continue administration of the protocol treatments until meeting the withdrawal criteria of this study.
[protocol treatments]
1.Induction therapy
[CBDCA + ETP + Durvalumab] every 3 weeks x 4 cycles
2.
Sponsors
Koichi Azuma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed small-cell lung cancer 2) Extensive-stage (ES)-SCLC 3) No prior systemic chemotherapy for ES-SCLC 4) 75 years of age or older 5) ECOG performance status of 0 to 1 6) With measurable lesions according to the RECIST criteria version 1.1 7) Written informed consent 8) Expected to survive for 12 weeks or longer 9) Body weight > 30kg
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within a year) malignancies 2) Active infection requiring systemic therapy and/or surgical procedures such as drainage 3) Active hepatitis B and C, and active tuberculosis 4) Interstitial lung disease on CT 5) Active autoimmune or inflammatory disease, or the history of autoimmune disease 6) Administration of immunosuppressants within 14 days prior to the protocol treatment 7) Grade2 or worse complications 8) Uncontrolled complications 9) Surgical treatment with general anesthesia within 14 days prior to the registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, median progression-free survival, 12-month overall survival rates, Completion rate of the induction therapy (4cycles), QOL (FACT-L), Comprehensive Geriatric Assessment (IADL) | — |
Contacts
Public ContactIshii Hidenobu
Kurume University Hospital
Outcome results
None listed