Phase II randomized study of the IGF-1R pathway modulator AXL1717 compared to docetaxel in patients with previously treated, locally advanced or metastatic non-small cell lung cancer

Figures & data

Figure 1. Study flow diagram.

Table 1. Baseline characteristics.

Parameters	AXL N = 58	DCT N = 41	Total
Median age (years); (Min/Max)	57 (42/81)	58 (44/73)	57 (42/81)
Sex, n (%)
Female	18 (31.0)	10 (24.4)	28 (28.3)
Male	40 (69.0)	31 (75.6)	71 (71.7)
Previous cancer treatment, n (%)
Chemotherapy	58 (100)	41 (100)	99 (100)
Surgery	19 (32.8)	14 (34.1)	33 (33.3)
Radiotherapy	4 (6.9)	10 (24.4)	14 (14.1)
ECOG performance, n (%)
0	12 (20.7)	12 (29.3)	24 (24.2)
1	43 (74.1)	28 (68.3)	71 (71.7)
2	3 (5.2)	1 (2.4)	4 (4.0)
Histologic subtype	N = 58	N = 41
AC	29 (50.0)	20 (48.8)	49 (49.5)
SCC	29 (50.0)	21 (51.2)	50 (51.5)
T classification^1	N = 58	N = 41
T1a	1 (1.7)	3 (7.5)	4 (4.0)
T2	29 (50.0)	16 (40.0)	45 (45.5)
T3	10 (17.2)	14 (35.0)	24 (24.2)
T4	9 (15.5)	3 (7.5)	12 (12.1)
T4a	8 (13.8)	4 (10.0)	12 (12.1)
Tx	1 (1.7)	1 (2.5)	2 (2.0)
N classification^1	N = 58	N = 41
N0	7 (12.1)	3 (7.5)	10 (10.1)
N1	7 (12.1)	8 (20.0)	15 (15.2)
N2	26 (44.8)	18 (45.0)	44 (44.4)
N3	16 (27.6)	10 (25.0)	26 (26.3)
Nx	2 (3.4)	2 (4.9)	4 (4.0)
M classification^1	N = 58	N = 41
M0	17 (29.3)	13 (31.7)	30 (30.3)
M1	37 (63.8)	25 (61.0)	62 (62.6)
Mx	4 (6.9)	3 (7.3)	7 (7.1)
Current tumor status^1	N = 58	N = 41
Metastatic	52 (89.7)	40 (97.6)	92 (92.9)
Locally advanced	6 (10.3)	1 (2.4)	7 (7.1)

¹ TNM classification refers to initial diagnosis. Current tumor status refers to study baseline.

Figure 2. Kaplan-Meier plot for overall survival.

Table 2. Summary of grade 3/4 treatment emergent adverse events and treatment-related adverse events overall and by preferred term occurring in two patients or more.

MedDRA Preferred term	AXL		DCT
	Overall n (%)	Related n (%)	Overall n (%)	Related n (%)
	N = 58	N = 58	N = 41	N = 41
Any TEAE	24 (41.4)	20 (34.5)	21 (51.2)	20 (48.8)
Blood and lymphatic system disorders	18 (31.0)	18 (31.0)	20 (48.8)	20 (48.8)
Neutropenia	15 (25.9)	15 (25.9)	17 (41.5)	17 (41.5)
Leukopenia	9 (15.5)	9 (15.5)	3 (7.3)	3 (7.3)
Anemia	6 (10.3)	6 (10.3)	1 (2.4)	–
Agranulocytosis	–	–	2 (4.9)	2 (4.9)
General disorders and administration site conditions	5 (8.6)	–	3 (7.3)	2 (4.9)
Fatigue	3 (5.2)	–	2 (4.9)	2 (4.9)
Respiratory, thoracic, and mediastinal disorders	3 (5.2)	1 (1.7)	3 (7.3)	1 (2.4)
Dyspnea	1 (1.7)	1 (1.7)	2 (4.9)	–
Pulmonary hemorrhage	2 (3.4)	–	–	–
Infections and infestations	3 (5.2)	2 (3.4)	–	–
Neoplasms benign, malignant, and unspecified (including cysts and polyps)	–	–	2 (4.9)	–
Nervous system disorders	–	–	2 (4.9)	–
Vascular disorders	2 (3.4)	–	–	–
Hypotension	2 (3.4)	–	–	–

AXL: AXL1717; DCT: docetaxel; MedDRA: Medical Dictionary for Regulatory Activities; TEAE: treatment emergent adverse event.