Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
Kyoto Prefectural University of Medicine
1. Department of Respiratory Medicine, Uji-Tokushukai Medical Center, Kyoto, Japan 2. Department of Respiratory Medicine, Otsu City Hospital, Shiga, Japan 3. Department of Medical Oncology, Fukuchiyama City Hospital, Kyoto, Japan 4. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan 5. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan 6. Department of Respiratory Medicine, Matsushita Memorial Hospital, Moriguch
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients between 20 and 75 years of age with ECOG-performance status (PS) 2, or patients over 75 years of age with PS 0-2 (2) Patients with advanced or recurrent non-small cell lung cancer with positive intratumoral programmed death-ligand 1 expression (3) Patients with evaluable lesions by RECIST(version.1.1) (4) Patients who are scheduled to receive first-line treatment with pembrolizumab monotherapy (5) Patients who have been fully informed of the contents of this clinical study and have given their free written consent
Exclusion criteria
Exclusion criteria: (1) Patients receiving concomitant treatment with other antineoplastic agents (cell-killing anticancer agents, molecular targeted agents, hormone therapy, other investigational agents, etc.) (2)Patients with a history of treatment with other cancer drug therapies (3)Patients who are eligible for treatment with platinum-based chemotherapy plus PD-1/PD-L1 inhibitor as initial systemic therapy (4) Patients with EGFR mutation or ALK fusion gene (5) Patients who are judged as inappropriate by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival of Pembrolizumab monotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, objective response rate, disease control rate, and disease-free survival of Pembrolizumab monotherapy Incidence and grade of adverse events, including immune-related adverse events, with pembrolizumab monotherapy | — |
Countries
Japan
Contacts
Public ContactShinsuke Shiotsu
Japanese Red Cross Kyoto Daiichi Hospital Clinical Oncology
Outcome results
None listed