Non-small cell lung cancer
Conditions
Interventions
Patient will receive 10 fractions of radiotherapy as determined by the location of the lesions to be irradiated.
The patient will begin concurrent immunotherapy(ipilimumab and nivolumab) within seven
Sponsors
Miyauchi Eisaku
NPO North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically confirmed NSCLC 2) Have a histologic diagnosis of stage IIIB, IIIC, IV,or recurrent NSCLC. 3) No sensitizing EGFR mutations or known ALK alterations. 4) Patients must be planning to receive ipilimumab and nivolumab therapy. 5) Have at least one metastatic site for radiation therapy(30Gy/10Fraction). 6) Aged >=20, at the time of consent 7) ECOG PS 0-1 8) Have at least one measurable lesion outside the field of irradiation by CT or MRI per RECIST 1.1 criteria 9) Have adequate organ function 10) Patients must be expected to survive more than three months. 11) Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1) Patients with sensitizing EGFR mutations or ALK alterations. 2) Patients with a past history of immunotherapy or radiation therapy. 3) Patients with symptomatic brain metastases. 4) Patients with an active autoimmune disease. 5) Patients with a past history of organ transplantation. 6) Patients with severe complications. 7) Patients with a known positive test for hepatitis B virus indicating acute or chronic infection. 8) Patients with interstitial lung disease by CT. 9) Patients with a condition requiring systemic treatment with corticosteroids. 10) Patients with pleural effusion requiring drainage. 11) Patients who are pregnant or lactating. 12) Patients with a past history of drug hypersensitivity. 13) Patients who have additional active malignancies. 14) Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| One year Progression-Free survival Rate , Disease Control Rate, Progression-Free survival, Overall Survival,Safety profiles, Matching adjusted indirect comparison analysis of ORR, PFS, and OS between the study treatment group and the group of patients enrolled in the CheckMate227 study | — |
Contacts
Public ContactYoko Tsukita
Tohoku University Hospital
Outcome results
None listed