non-small-cell lung cancer
Conditions
Interventions
Pembrolizumab (200mg/body q3w)or Nivolumab (240mg/body q2w)
Sponsors
National cancer center hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet the following criteria for each cohort and plan to receive atezolizumab; Cohort A: Subjects with histologically confrmed Stage IIIB/IV or recurrent NSCLC (UICC TNM 8th). No history of the treatment of anti PD-L1, anti-CTLA-4 antibody or drugs of effect to T cell. Cohort B: Subjects with histologically confrmed Stage IIIB/IV or recurrent NSCLC (UICC TNM 8th). Previous chemotherapy consisting of platinum. No history of the treatment of anti PD-L1, anti-CTLA-4 antibody or drugs of effect to T cell. Both cohort: Without symptomatic brain metastasis, carcinomatous meningitis, and bone metastasis requiring radio therapy or surgery. Without pericardial, pleural effusion, or ascites requiring the treatment. Ages 20 <=years of age at registration. ECOG Performance Status of <=1. Measurable disease by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment performed within 28 days of registration. Without a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of registration. Screening laboratory values must meet the following criteria (within 14 days of registration): 1. Neutrophil >= 1500 / mm3 2. Platelet >= 10 x 10^4 / mm3 3. Hb >= 8.0 g/dL 4. AST(GOT)<= 100 U/L 5. ALT(GPT)<= 100 U/L 6. Total bililubin <= 1.5 mg/dL. SpO2 >= 90 within 14 days of registration. Consent to contraception for at least 31 weeks after the final administration of treatment from the day of the consent Subjects must have signed written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects with an active infection requiring systemic treatment. History of the treatment of anti PD-L1, anti-CTLA-4 antibody or drugs of effect to T cell. Subjects with an active Gastrointestinal ulcer. Subjects with past or present history of interstitial lung disease diagnosed by clinical or imaging findings. History of allergy or hypersensitivity to study drug components. Subjects with an active or refractory autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Known history of testing positive for HIV antibody, HBs antigen, HCV antibody and HCV-RNA. If HBs antibody or HBc antibody was positive, subjects testing negative for HBV-DNA is permitted to enroll. Subjects who are or may be pregnant, or are breast-feeding. Subjects with psychiatric illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate of anti-PD-1 therapy after anti-PD-L1 therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival, overall survival, duration of response, safety | — |
Countries
Japan
Contacts
Public ContactMunehiro Ito
National cancer center hospital Department of Thoracic Oncology
Outcome results
None listed