Non-small cell lung cancer
Conditions
Interventions
Atezolizumab 1,200 mg/body is administered every three weeks.
Docetaxel 60 mg/m2+ramucirumab 10 mg/kg are administered every three weeks.
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cytologically or histologically confirmed non-small cell lung cancer. 2) TPS<=49% has been confirmed with a test with PD-L1 IHC 22C3 pharmDx using tissue samples. 3) No EGFR gene mutation, ALK fusion gene, or ROS1 fusion gene. 4) Clinical stage IIIB without indication of definitive thoracic radiotherapy, stage IV, or postoperative recurrent disease. 5) Aged 20 or older 6) At least one lesion measureable based on RECIST 1.1 Guideline. 7) Have received a regimen of platinum-based therapy as a pre-treatment (without docetaxel) 8) No history of treatment with anti PD-1 antibodies, anti PD-L1 antibodies, anti CTLA-4 antibodies, or another antibody or agent that specifically targets the T-cell co-stimulatory pathway or checkpoint pathway. 9) Performance status (PS) is 0 or 1 in ECOG criteria. 10) Patients who are expected to live for at least three months. 11) No active hepatitis B infection. 12) It has been one week or more since a radiotherapy for metastasis (including gamma knife therapy for brain metastasis) (with the final day of the therapy as Day 1, it is Day 8 or more). 13) No symptomatic brain metastasis, or spinal metastasis requiring radiation or surgical treatment. 14) No symptomatic superior vena cava syndrome. 15) No pericardial effusion, pleural effusion, or ascites that cannot be controlled.
Exclusion criteria
Exclusion criteria: 1) Active multiple primary cancers. 2) A history of autoimmune disease. However, the following cases are allowed to register. -Controlled type 1 diabetes with stable insulin usage. -Hypothyroidism that can be managed with hormone replacement therapy 3) Requires systemic adrenal steroid (equivalent of prednisone exceeding 10 mg/day) or another immunosuppressant within 14 days of the registration. 4) History of serious or non-healing wounds, ulcers, or fractures that are serious within 28 days before registration. 5) History of hypersensitivity to drugs containing polysorbate 80. 6) History of serious hypersensitivity. 7) Presence of local or systemic active infection 8) CT findings clearly show interstitial pneumonia. 9) Hemoptysis within two months of registration (>= 1/2 tsp). 10) History of digestive tract perforation, peptic ulcer, diverticulosis, or fistula within six months before registration. 11) History or the presence of intestinal obstruction, inflammatory bowel disorder, extensive intestinal resection (hemicolectomy or extensive small bowel resection due to chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. 12) History of uncontrollable thrombosis or embolism. 13) Vasculitis, grade 3 or worse gastrointestinal bleeding, or clinically serious bleeding within three months of registration. 14) Arterial thrombosis such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within six months before trial treatment. 15) Congestive heart failure of New York Heart Association (NYHA) Class II or worse. 16) Diabetes that cannot be controlled even with an appropriate treatment. 17) Hypertension that cannot be controlled with a standard medical treatment (systolic blood pressure of 150 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, response rate, duration of response, safety, rate of receiving crossover treatment | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed