non-small cell lung cancer
Conditions
Interventions
Palliative radiotherapy (30Gy/10fr) (a)If lung leasion, V20 equal or less than 20% (b)Planning target volume(PTV)volume equal or more than 50 cm3 and equal or less than 400 cm3
Sponsors
Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Cytologically or histologically confirmed non-small cell lung cancer 2)Clinical stage IIIB, IIIC without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease 3)EGFR mutation status is not active and ALK fusion gene is negative 4)Administrate pembrolizumab and cytotoxic agents for 1st-line therapy 5)Leasions suitable for palliative radiotherapy (30Gy/10fr) (a)If lung leasion, V20 equal or less than 20% (b)PTV(planning target volume)volume equal or more than 50 cm3 equal or less than 400 cm3 6)Aged 20 or older 7)Eastern Cooperative Oncology Group Performance Status (ECOG PS) is 0 or 1 8)At least one measurable lesions except radiation site (RECIST ver1.1) 9)Patients with adequate organ function 10)Patients expected to survive for more than 3 months 11)Have given written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1)Presence of EGFR mutation, ALK fusion gene, ROS1 fusion gene or BRAF mutation 2)Prior immunotherapy or radiotherapy 3)Symptomatic brain metastases 4)Patient with autoimmune disease 5)Patient with history of organ transplantation 6)Severe complication (uncontrolled heart failure, renal failure, chronic liver failure, diabetes mellitus, intestinal obstruction, active gastrointestinal ulceration, etc.) 7)Positive for hepatitis B surface (HBs) antigen or detectable HB virus DNA with positive for HBs antibody or hepatitis B core antibody 8)Radiographically confirmed interstitial pneumonitis 9)Receiving continuous systemic corticosteroid or immunosuppressant treatment or within 2 weeks after discontinuation 10)Pleural effusion, ascites or pericardial effusion requiring drainage 11)Pregnant or lactating females, females of child-bearing potential, and males desiring partner's pregnancy 12)Patient with active double cancer. (Exclude disease free interval over 5 years and carcinoma in situ) 13)History of severe drug allergies 14)Other ineligible status judged by attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Disease control rate, Progression-free survival, Overall survival, Safety | — |
Countries
Japan
Contacts
Public ContactYoko Tsukita
Tohoku University Hospital Department of Respiratory Medicine
Outcome results
None listed