Non-small cell lung cancer Oligo-Progressive disease
Conditions
Interventions
1.Experimental: Local Consolidative Radiation Therapy Arm
1.1. Local Therapy
Patients will receive radiotherapies to all progressive lesions determined by a multidisciplinary tumor board (including sp
Sponsors
Shukuya Takehito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The age is 20 and older 2.Agreement has been obtained from the individual patient. 3.Histologically confirmed non-small cell lung cancer 4. No or unknown activating driver mutation: EGFR, ALK, ROS1, BRAF, MET, KRAS, RET 5.Patients who received first-line platinum-based chemotherapy plus immune checkpoint inhibitors and who had progressive disease 6.Patients whose response to first-line treatment was confirmed SD/PR/CR according to RECIST ver1.1 criteria 7.Patients with no history of radiotherapy for progressive lesions 8.Progressive lesions are 1-3. 9.The patient must be a suitable candidate for local therapy radiotherapy to every site of progressive disease. 10.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 11.The functions of the main organs are maintained, and all the criteria stated below are satisfied. a) WBC >= 1500/mm3 b) Neutrophil count >= 1,500 /mm3 c) Hemoglobin: >=9.0 g/dl d) Platelet count: >=100,000/mm3 e) Both AST and ALT: =92% in the state of no oxygen inhalation (room climate)
Exclusion criteria
Exclusion criteria: 1.Patients with progression exclusively to brain metastases 2.Patients with progression of malignant pleural effusion, pericardial effusion, ascites, pleural dissemination, meningeal dissemination, or peritoneal dissemination 3.Patients with progression of carcinomatous lymphangiosis 4.Patients with history of another primary malignancy 5.Patients with active infection requiring systemic therapy. 6.Patients with active hepatitis B or C. 7.Pregnant women, lactating women, and women who may be currently pregnant 8.Patients with psychiatric comorbidities resulting in clinical problems 9.Active autoimmune disease that has required systemic treatment 10.Patients with poorly controlled diabetes 11.Patients with symptomatic congestive heart failure, unstable angina pectoris, or history of myocardial infarction within 1 year prior to enrollment 12.Patients with interstitial lung disease 13.Patients chronically receiving steroids (PSL 10 mg/day or more) or systemic immunosuppressive drugs. 14.Patients with a history of serious hypersensitivity reactions to other monoclonal antibodies 15.Patients with hypersensitivity to the drug to be administered 16.Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| safety, overall survival, proportion of local therapy completion, proportion of transition to maintenance therapy, form of progressive disease, response rate | — |
Contacts
Public ContactMiyawaki Taichi
Department of Respiratory Medicine, Juntendo University Graduate School of Medicine
Outcome results
None listed