non-small-cell lung cancer
Conditions
Interventions
investigational material(s)
Generic name etc : atezolizumab
INN of investigational material : atezolizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investig
Sponsors
Nobuyuki Yamamoto (Coordinating Investigator)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.ECOG PS 0 or 1 2.Patients with a histologically or cytologically confirmed diagnosis of NSCLC 3.Pathologic stage II or IIIA (UICC TNM Classification 8th edition) 4.Proven EGFR gene mutation status (Exon19 deletion/ Exon21 L858R) 5.Twenty-one or more days after surgery but within 56 days after surgery, confirmed completely resection as negative margins, and post-operative recovery 6.Patients with mediastinal lymph node dissection or lymph node sampling 7.Patients who were not previously treated with chemotherapy nor EGFR TKI 8.The functions of the hematopoiesis and main organs are maintained, and all the criteria are satisfied.
Exclusion criteria
Exclusion criteria: 1.Patients with other cancers except for NSCLC within 5 years 2.Patients with a history of autoimmune disease 3.Patients with active hepatitis B and/or C 4.Patients with a history of other surgeries except lung cancer resection, vaccination with a live-attenuated vaccine, or possibility of these therapy during the trial 5.Patients with a history of other study drug administration within 28 days 6.Patients with hypersensitivity to the ingredients or additives of cisplatin, vinorelbine, atezolizumab or mannitol 7.Pregnant women, lactating women, or patients not intending to practice contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Two years disease free survival (DFS) rate. DFS will be assessed according to RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy DFS, overall survival (OS), and safety DFS will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on. | — |
Countries
Japan
Outcome results
None listed