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
Isamu Okamoto (Coordinating Investigator)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with a histologically or cytologically confirmed diagnosis of non-squamous NSCLC 2. Patients who have the results of EGFR mutation test 3. Patients with stage III and stage IV NSCLC not treatable with radical radiotherapy or postoperative recurrent NSCLC 4. Patients with tumor lesion, regardless of with or without measurable lesion as defined by the RECIST version 1.1 5. Absence of symptomatic brain metastasis 6. Patients who were not previously treated with chemotherapy, in the patients confirmed to be positive-mutation in any driver gene, need previously treatment by appropriate TKI 7. ECOG PS 0 or 1
Exclusion criteria
Exclusion criteria: 1.Patients with active other cancers except for NSCLC 2.Patients with a past or current history of hemoptysis 3.Presence of a bleeding tendency 4.Patients with an interstitial lung disease evident on CT scans 5.Hypertension uncontrollable with standard drug therapy 6.Patients with hypersensitivity to the ingredients or additives of carboplatin, pemetrexed, atezolizumab or bevacizumab 7.Pregnant women, lactating women, women who may be pregnant at present or patients not intending to practice contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Progression free survival (PFS) by central assessment PFS will be assessed according to RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Investigator-assessed PFS, overall survival (OS), investigator-assessed overall response rate (ORR), investigator assessed duration of response (DOR) and safety PFS, ORR and DOR 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