Table 1 Demographics and baseline disease characteristics
a. All monotherapy | 1.3 mg kg−1 n = 10 | 1.8 mg kg−1 n = 71 | 2.5 mg kg−1 n = 139 | 3.0 mg kg−1 n = 15 | 3.5 mg kg−1 n = 5 | Total N = 240 |
|---|---|---|---|---|---|---|
Median age, years (range) | 65 (52−76) | 62 (35−85) | 61 (18−86) | 59 (32−78) | 71 (51−73) | 62 (18−86) |
Sex, n (%) | ||||||
Male | 3 (30) | 49 (69) | 81 (58) | 10 (67) | 1 (20) | 144 (60) |
Female | 7 (70) | 22 (31) | 58 (42) | 5 (33) | 4 (80) | 96 (40) |
Race, n (%) | ||||||
Asian | 0 | 33 (47) | 31 (22) | 4 (27) | 0 | 68 (28) |
Black/African American | 1 (10) | 0 | 5 (4) | 2 (13) | 1 (20) | 9 (4) |
White | 7 (70) | 36 (51) | 98 (71) | 9 (60) | 4 (80) | 154 (64) |
Not reported | 2 (20) | 2 (3) | 5 (4) | 0 | 0 | 9 (4) |
Tobacco use, n (%) | ||||||
Current | 1 (10) | 6 (9) | 19 (14) | 3 (20) | 1 (20) | 30 (13) |
Former | 9 (90) | 57 (80) | 59 (42) | 5 (33) | 2 (40) | 132 (55) |
Never | 0 | 8 (11) | 61 (44) | 7 (47) | 2 (40) | 78 (33) |
ECOG PS, n (%) | ||||||
0 | 3 (30) | 12 (17) | 37 (27) | 5 (33) | 0 | 57 (24) |
1 | 7 (70) | 59 (83) | 102 (73) | 10 (67) | 5 (100) | 183 (76) |
Disease type, n (%) | ||||||
SCLC | 8 (80) | 63 (89) | 44 (32) | 7 (47) | 2 (40) | 124 (52) |
High-grade NENs or CNS tumors | 2 (20) | 8 (11) | 95 (68) | 8 (53) | 3 (60) | 116 (48) |
b. R/R SCLC monotherapy | Part 2a 1.8 mg kg−1 n = 41 | Part 2a 1.8 mg kg−1 2L n = 17 | Part 2a 2.5 mg kg−1 n = 39 | Part 1 + 2a + 2c (n = 124) |
|---|---|---|---|---|
Median age, years (range) | 64 (48−85) | 62 (50−68) | 66 (51−81) | 64 (35−85) |
Sex, n (%) | ||||
Male | 25 (61) | 11 (65) | 19 (49) | 73 (59) |
Female | 16 (39) | 6 (35) | 20 (51) | 51 (41) |
Race, n (%) | ||||
Asian | 16 (39) | 6 (39) | 12 (31) | 49 (40) |
Black/African American | 0 | 0 | 1 (3) | 3 (2) |
White | 24 (59) | 10 (59) | 25 (64) | 69 (56) |
Not reported | 1 (2) | 1 (6) | 1 (3) | 3 (2) |
Tobacco use, n (%) | ||||
Current | 4 (10) | 2 (12) | 8 (21) | 21 (17) |
Former | 36 (88) | 15 (89) | 29 (74) | 95 (77) |
Never | 1 (2) | 0 | 2 (5) | 8 (7) |
ECOG PS, n (%) | ||||
0 | 9 (22) | 5 (29) | 7 (18) | 24 (19) |
1 | 32 (78) | 12 (71) | 32 (82) | 100 (81) |
Stage IV at study entry, n (%) | 35 (85) | 15 (88) | 36 (92) | 111 (90) |
Brain metastasis at study entry, n (%) | 16 (39) | 7 (41) | 12 (31) | 42 (34) |
Whole-brain radiotherapy as most recent radiotherapy | 7 (17) | 4 (24) | 7 (18) | 19 (15) |
Prior lines of therapy | ||||
Median (range) | 2 (1−6) | 1 (1−1) | 2 (1−6) | 2 (1−6) |
1, n (%) | 17 (42) | 17 (100) | 14 (36) | 43 (35) |
≥2, n (%) | 24 (59) | 0 | 25 (64) | 81 (65) |
Select prior lines of therapy | ||||
Top1i | 12 (29) | 1 (6) | 11 (28) | 35 (28) |
Tarlatamab | 3 (7) | 0 | 0 | 8 (7) |
Anti-PD-L1 | 33 (81) | 13 (77) | 31 (80) | 103 (83) |
Lurbinectedin | 10 (24) | 0 | 7 (18) | 25 (20) |
Platinum | 41 (100) | 17 (100) | 39 (100) | 124 (100) |
Top2i | 40 (98) | 16 (94) | 37 (95) | 121 (98) |
CTFI, n (%) | ||||
≥90 days | 12 (29) | 4 (24) | 18 (46) | 44 (36) |
<90 days | 25 (61) | 13 (77) | 17 (44) | 66 (53) |
<30 days | 11 (27) | 4 (24) | 8 (21) | 29 (23) |
Missing | 4 (10) | 0 | 4 (10) | 14 (11) |
