Non-small cell lung cancer Non-small cell lung cancer
Conditions
Interventions
Experimental arm
(1) Palliative radiation therapy
Palliative radiation at a total dose of 30Gy (3Gyx10) or the equivalent dose (for example, 2Gy x 20-25) to any organ with lung cancer except for the brain.
(2) Z-100 (
Any treatment which his/her doctor decides
ICI(immune check point inhibitor) , Radiation, Z-100 (Ancer)
Sponsors
Kasahara Kazuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with a diagnosis of non-small cell lung cancer (NSCLC). (2) Patients that are in stage IIIb, IIIc or stage IVa, IVb, IVc or have recurrence postoperatively without indication for surgical or radical radiation therapy. (3) No EGFR gene mutation or no ALK fusion gene (4) Patients who became refractory to previously effective ICI treatment (5) Having a palliative radiation field except for brain metastasis, and having a measurable lesion(s) evaluated by RECIST (version1.1) outside of the palliative radiation field (6) From 20 to 80 years of age (7) PS 0 or 1 (ECOG) (8) Normal main organ functions (in principle, they should have the following values.) 1)Absolute neutrophil count >=1,500/mm3 2)Hemoglobin >= 9.0 g/dl 3)Platelet count >= 100,000/mm3 4)AST,ALT = 95 % (9) Life expectancy >= 12 weeks (10) Written informed consent must be given
Exclusion criteria
Exclusion criteria: (1) Patients with synchronous multiple cancer or metachronous multiple cancer with <=5 years of disease-free interval (2) Patients with interstitial pneumonia (UIP, probable UIP) confirmed by chest CT, drug-induced Interstitial lung disease or clinically active interstitial lung disease (3) Any evidence of active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). (4) Patients with primary immunodeficiency (5) Patients with disease that has an impact on digestive function, such as total gastrectomy or active inflammatory bowel disease. (6) Active or prior documented inflammatory bowel disease such as Crohn's Disease, and ulcerative colitis. (7) Patients with severe complications such as uncontrolled heart, lung, liver, or kidney disease. (8) Patients that have received systemic administration of steroids at a dose of more than 10mg of prednisolone (or equivalent to this) for 4 weeks or longer. (9) Active or prior documented autoimmune disease within the past 2 years. (10)Male patients without an intention to use the measures of contraception. Or pregnant women, lactating women, women who are positive for pregnancy tests or women without an intention to use the measures of contraception. (11)Known allergy or hypersensitivity to any of the study drugs (12)History of allogenic organ transplantation (13)Previously treatment by Z-100 (Ancer) (14)Other cases that are determined to be inappropriate by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year OS (Overall Survival) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment duration of an ICI 2.Difference in survival of patients with or without irAE 3.Safty 4.Overall Survival 5.Progression-free survival 6.Accompanying research: Functional changes in peripheral blood lymphocytes | — |
Contacts
Public ContactSusumu Takeuchi
Nippon Medical School Hospital
Outcome results
None listed