Non-small cell lung cancer Non-small cell lung cancer
Conditions
Interventions
(1)Continuing an ICI
*nivolumab 240mg div biweekly or 480mg every 4 weeks
*pembrolizumab 200mg div triweekly, 400mg div every 6 weeks
*atezolizumab 1200mg div triweekly
*nivolumab 360mg div triweekly
ICI(immune check point inhibitor),Radiation,Z100 (Ancer)
Sponsors
Kobayashi Kunihiko
Nonprofit Organization, North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with a diagnosis of non-small cell lung cancer (NSCLC). (2)EGFR mutation positive , EGFR mutation negative, or unknown (3)Patients that are in stage IIIb, IIIc or stage IVa, IVb, IVc or have recurrence postoperatively without indication for surgical or radical radiation therapy. (4)Inactive ICI by nivolumab, pembrolizumab, atezolizumab or ipilimumab+nivolumab, as defined by *disease progression in stable disease (SD) or progressive disease (PD) with longitudinal elevation (>=2 points) of a tumor marker [*] from 8 to 12 weeks after starting an ICI *progressive disease (PD) after 12 weeks after starting an ICI *stable disease (SD) with longitudinal elevation (>=2 points) of a tumor marker [*] after 12 weeks after starting an ICI [*]CEA, SLX, CA19-9, CYFRA, SCC, proGRP, NSE (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 79 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 470 msec calculated from ECG (12)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. (13)Known allergy or hypersensitivity to any of the study drugs (14)History of allogenic organ transplantation (15)Previously treatment by Z-100 (Ancer) (16)Other cases that are determined to be inappropriate by attending physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety (Adverse events graded by CTCAE version 5.0), Progression-free survival rate at 9 months (by extramural review based on RECIST version 1.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Objective response rate, disease control rate (Extramural review based on RECIST version 1.1) (2)Progression-free survival (Extramural review based on RECIST version 1.1) (3)Treatment duration of an ICI (4)Overall Survival (5)2 years survival rate (6)Changes in immunocompetent cells | — |
Contacts
Public ContactYou Miura
Saitama Medical University International Medical Center
Outcome results
None listed