Table 1.
Demographic and baseline clinical characteristics.
| Characteristic | Concurrent cohort (n = 22) | Delayed cohort (dose-finding part only) (n = 10) |
|---|---|---|
| Age, median (range), years | 65.0 (38–77) | 70.0 (44–82) |
| <65 years, n (%) | 10 (45.5) | 4 (40) |
| ≥65 years, n (%) | 12 (54.5) | 6 (60) |
| Sex, n (%) | ||
| Male | 6 (27.3) | 7 (70.0) |
| Female | 16 (72.7) | 3 (30.0) |
| Race, n (%) | ||
| White | 18 (81.8) | 8 (80.0) |
| Asian | 1 (4.5) | 0 |
| Black or African American | 0 | 2 (20.0) |
| Not collected or reported | 3 (13.6) | 0 |
| ECOG PS, n (%) | ||
| 0 | 7 (31.8) | 6 (60.0) |
| 1 | 15 (68.2) | 4 (40.0) |
| Stage at primary diagnosis, n (%) | ||
| IA | 2 (9.1) | 0 |
| IB | 1 (4.5) | 0 |
| IIB | 0 | 1 (10.0) |
| IIIA | 2 (9.1) | 1 (10.0) |
| IIIB | 1 (4.5) | 2 (20.0) |
| IVA | 10 (45.5) | 3 (30.0) |
| IVB | 4 (18.2) | 2 (20.0) |
| Unknown | 2 (9.1) | 1 (10.0) |
| Histology, n (%) | ||
| Confirmed | 21 (95.5) | 10 (100.0) |
| Adenocarcinoma | 12 (54.5) | 5 (50.0) |
| Squamous cell carcinoma | 7 (31.8) | 2 (20.0) |
| Large cell carcinoma | 0 | 1 (10.0) |
| Other | 2 (9.1) | 2 (20.0) |
| Not confirmed | 1 (4.5) | 0 |
| PD-L1 category, n (%) | ||
| <1% | 6 (27.3) | 5 (50.0) |
| ≥1% | 12 (54.5) | 2 (20.0) |
| Missing | 4 (18.2) | 3 (30.0) |
| KRAS status, n (%) | ||
| KRAS mutant | 3 (13.6) | 2 (20.0) |
| KRAS wild type | 3 (13.6) | 2 (20.0) |
| Unknown | 16 (72.7) | 6 (60.0) |
| ALK status, n (%) | ||
| ALK wild type | 9 (40.9) | 6 (60.0) |
| Unknown | 13 (59.1) | 4 (40.0) |
| EGFR status, n (%) | ||
| EGFR mutant | 2 (9.1) | 1 (10.0) |
| EGFR wild type | 8 (36.4) | 4 (40.0) |
| Unknown | 12 (54.5) | 5 (50.0) |
| Prior anticancer therapy, n (%) | ||
| Systemic therapya | 5 (22.7) | 1 (10.0) |
| Radiation | 9 (40.9) | 3 (30.0) |
| Surgery | 5 (22.7) | 5 (50.0) |
ALK, anaplastic lymphoma kinase; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; PD-L1, programmed death ligand 1.
a
Two patients in the concurrent cohort received a tyrosine kinase inhibitor (1 each received afatinib and erlotinib); none of the patients in the delayed cohort received a tyrosine kinase inhibitor.