Introduction
Methods
Patients
Study design
Endpoints
Assessments
Statistics
Results
Characteristic | Cohort 1 Pembrolizumab Plus Cisplatin/Etoposide (n = 6) | Cohort 2 Pembrolizumab Plus Carboplatin/Etoposide (n = 6) | Cohort 3 Pembrolizumab Plus Cisplatin/Etoposide Plus Pegfilgrastim (n = 3) | Total (N = 15) |
---|---|---|---|---|
Age, y | ||||
Median | 63.5 | 65.0 | 57.0 | 64.0 |
Range | 60‒70 | 51‒80 | 55‒70 | 51‒80 |
Male | 3 (50) | 4 (67) | 1 (33) | 8 (53) |
ECOG PS | ||||
0 | 2 (33) | 2 (33) | 3 (100) | 7 (47) |
1 | 4 (67) | 4 (67) | 0 | 8 (53) |
Former/current smoker | 5 (83) | 5 (83) | 2 (67) | 12 (80) |
Metastatic stage | ||||
M1 | 0 | 1 (17) | 0 | 1 (7) |
M1A | 0 | 1 (17) | 1 (33) | 2 (13) |
M1B | 6 (100) | 4 (67) | 2 (67) | 12 (80) |
Brain metastases | 3 (50) | 1 (17) | 1 (33) | 5 (33) |
Mean ± SD baseline tumor size, mm | 149.6 ± 70.5 | 143.6 ± 77.7 | 64.4 ± 17.6 | 130.2 ± 71.7 |
Safety
Adverse Event | Cohort 1 Pembrolizumab Plus Cisplatin/Etoposide (n = 6) | Cohort 2 Pembrolizumab Plus Carboplatin/Etoposide (n = 6) | Cohort 3 Pembrolizumab Plus Cisplatin/Etoposide Plus Pegfilgrastim (n = 3) | |||
---|---|---|---|---|---|---|
Treatment-related AEs | 6 (100) | 6 (100) | 3 (100) | |||
Grade 3/4 treatment-related AEs | 6 (100) | 6 (100) | 2 (67) | |||
Serious treatment-related AEs | 3 (50) | 2 (33) | 0 | |||
Deaths due to a treatment-related AE | 0 | 0 | 0 | |||
Discontinued due to a treatment-related AE | 1 (17) | 1 (17) | 0 |
Treatment-related AEs of any grade occurring in ≥ 2 patients or of grade 3/4 in ≥ 1 patient | Any Grade | Grade 3/4 | Any Grade | Grade 3/4 | Any Grade | Grade 3/4 |
---|---|---|---|---|---|---|
Leukopenia | 6 (100) | 5 (83) | 6 (100) | 3 (50) | 2 (67) | 2 (67) |
Neutropenia | 5 (83) | 5 (83) | 6 (100) | 6 (100) | 2 (67) | 2 (67) |
Constipation | 4 (67) | 0 | 1 (17) | 0 | 1 (33) | 0 |
Febrile neutropenia | 3 (50) | 3 (50) | 1 (17) | 1 (17) | 0 | 0 |
Decreased appetite | 3 (50) | 0 | 4 (67) | 0 | 2 (67) | 0 |
Alopecia | 3 (50) | 0 | 2 (33) | 0 | 2 (67) | 0 |
Nausea | 3 (50) | 0 | 2 (33) | 0 | 2 (67) | 0 |
Hyponatremia | 2 (33) | 1 (17) | 1 (17) | 1 (17) | 0 | 0 |
Interstitial lung disease | 2 (33) | 1 (17) | 0 | 0 | 0 | 0 |
Anemia | 2 (33) | 0 | 6 (100) | 1 (17) | 2 (67) | 0 |
Laryngeal stenosis | 1 (17) | 1 (17) | 0 | 0 | 0 | 0 |
Thrombocytopenia | 1 (17) | 0 | 2 (33) | 0 | 2 (67) | 0 |
Diarrhea | 1 (17) | 0 | 1 (17) | 1 (17) | 1 (33) | 0 |
Pruritus | 0 | 0 | 3 (50) | 0 | 0 | 0 |
Stomatitis | 0 | 0 | 3 (50) | 0 | 0 | 0 |
Lymphopenia | 0 | 0 | 2 (33) | 2 (33) | 0 | 0 |
Malaise | 0 | 0 | 2 (33) | 0 | 1 (33) | 0 |
Dysgeusia | 0 | 0 | 2 (33) | 0 | 0 | 0 |
Lichenoid keratosis | 0 | 0 | 1 (17) | 1 (17) | 0 | 0 |
Peripheral sensory neuropathy | 0 | 0 | 1 (17) | 1 (17) | 0 | 0 |
Immune-mediated AEsa | ||||||
Adrenal insufficiency | 0 | 0 | 0 | 0 | 1 (33) | 0 |
Pneumonitis | 2 (33) | 1 (17) | 0 | 0 | 0 | 0 |
Hypothyroidism | 0 | 0 | 0 | 0 | 1 (33) | 0 |
Hyperthyroidism | 0 | 0 | 0 | 0 | 1 (33) | 0 |