Non-small Cell Lung Cancer
Conditions
Interventions
Chemotherapy including immune checkpoint inhibitors (standard therapy) topped up with Tsudosan
Sponsors
Himuro Hidetomo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following conditions are met 1. clinical stage IIIB, IIIC, IVA, IVB or recurrent non-small cell lung cancer that cannot be radically irradiated, as confirmed by histology or cytology 2. planned treatment with immune checkpoint inhibitors 3. Patients with an insurance indication for Tsudosan 4. Patients expected to be alive for at least 3 months at the time of enrollment 5. ECOG performance status (PS) of 0 to 2 6. preserved major organ function 7. have been fully informed about the study and have obtained written consent from the patient or a surrogate
Exclusion criteria
Exclusion criteria: Any of the following 1. history of treatment with immune checkpoint inhibitors 2. have concurrent overlapping cancers or iatrogenic overlapping cancers with a disease-free interval of 5 years or less 3. have a history of concomitant autoimmune disease or chronic or recurrent autoimmune disease 3. concomitant autoimmune disease or history of chronic or recurrent autoimmune disease 4. active or symptomatic interstitial pneumonia 4. with active or symptomatic interstitial pneumonia and with background lung of inactivaative interstitial pneumonia 5. having an infectious disease requiring systemic treatment 6. psychosis or psychiatric comorbidities that would preclude participation in the study 7. symptomatic brain metastases 8. has serious comorbidities 9. has active liver disease 9. has active liver disease 10. receiving systemic administration of steroids in excess of 10 mg/day 11. Patients unwilling to use contraception. Or pregnant or lactating women. 12. patients with a history of serious hypersensitivity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PhaseI : Incidence of serious treatment-related adverse events (8 weeks after treatment initiation) PhaseII : Progression-free survival at 6 months (day180) after the start date of immune checkpoint inhibitor treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| PhaseI : Incidence of serious treatment-related adverse events (12 weeks after treatment initiation), Other treatment-related adverse events (8,12 weeks after treatment initiation) PhaseII : Safety, Disease control rate at 12 weeks after initiation of immune checkpoint inhibitor therapy, Progression-free survival(PFS), Overall survival(OS), Time to treatment failure(TTF), Duration of treatment, Duration of response, Evaluation of the relationship between gut microbiota and various endpoints, Evaluation of the relationship between immune factors in peripheral blood and various endpoints | — |
Contacts
Public ContactHidetomo Himuro
Kanagawa Cancer Center
Outcome results
None listed