Lung cancer
Conditions
Interventions
Nivolumab
Nivolumab plus docetaxel
Sponsors
Thoracic Oncology Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed NSCLC. 2.Previously treated, at least one regimen cytotoxic chemotherapy, and stage III or IV or post operation recurrence. 3.Less than 2 regimen previous chemotherapy. EGFR-TKI and ALK-TKI are not regarded as regimen. 4.Aged 20 years or older. 5.ECOG performance status 0 to 1. 6.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Previously treated by docetaxel. 2.Previously treated by antibody targeting to PD-1, PD-L1, PD-L2, CD137, or CTLA-4. 4.Synchronous or metachronous (within 5 years) malignancies, except for carcinoma in situ or mucosal tumors curatively treated with local therapy. 5.Active CNS metastasis or meningitis carcinomatous. (If patients were received brain radiation, and stable clinically, it is eligible.) 6.Evident interstitial pneumonia in CT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: 6 months PFS, Grade 3 =< pneumonitis rate(within 12 weeks) Phase III: Overall survival, Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Response rate Phase III: Progression-free survival, Objective response rate, Safety | — |
Countries
Japan
Contacts
Public ContactTsuneo Shimokawa
Yokohama Municipal Citizen's Hospital Respiratory Medicine
Outcome results
None listed