Non-Small Cell Lung Cancer
Conditions
Interventions
All patients will receive platinum-doublet + durvalumab + tremelimumab as protocol treatment. Protocol treatment is continued until discontinuation criteria are met, such as disease progression or una
Sponsors
TSUBATA Yukari
Nonprofit Organization, North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 2.Negative or unknown activating driver oncogene mutation/ translocation. 3.Patients must have received definitive concurrent chemoradiotherapy and durvalumab as consolidation therapy for NSCLC (locally advanced, unresectable, stage III or post operative, locally reccurent disease). 4.Durvalumab has not been permanently discontinued due to adverse events (AEs), or durvalumab has been held due to AEs and subsequently reinitiated. 5.Disease progression was observed at least 4 months after the date of completion of thoracic radiotherapy, and disease progression was observed during durvalumab therapy or within 6 months of the last dose of durvalumab. 6.Age is at least 18 years. 7.ECOG Performance status of 0 or 1. 8.Meet the following criteria for major organ function within 14 days prior to enrolment. a.Neutrophil count: >= 1,500 /mm3 b.Hemoglobin: >= 9.0 g/dL c.Platelet count: >= 10.0 x 104 /mm3 d.AST, ALT: = 95 %(room air)
Exclusion criteria
Exclusion criteria: 1.Active interstitial lung disease, or radiation pneumonitis/ organizing pneumonia due to radiation therapy requiring corticosteroids. 2.Previous immunotherapy has caused >=Grade 3 immune-related adverse events (irAEs) defined by CTCAE v5.0 (excluding endocrine disorders), or irAEs have not improved to the baseline condition prior to initiation of immunotherapy (excluding endocrine disorders). 3.Clinically unstable or symptomatic brain metastasis, meningeal carcinomatosis or spinal cord compression. 4.Active Hepatitis B or C, HIV infection, or active tuberculosis infection. 5.Active autoimmune disease, history of immunodeficiency or serious complications. 6.Another primary malignancy within 5 years. 7.Patients who are judged inappropriate to participate in the study by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), 1-year PFS rate, 1-year OS rate, safety | — |
Contacts
Public ContactYukari TSUBATA
Shimane University Hospital
Outcome results
None listed