Table 6 Overall response rate analysis by patient factor in the effectiveness analysis set.

Effectiveness analysis set

64

43 (67.19)

–

Sex

 Male

42

26 (61.90)

Reference

 Female

22

17 (77.27)

2.092 (0.646-6.779)

Age category

 < 15 years

0

–

 ≥ 15 to < 65 years

17

12 (70.59)

Reference

 ≥ 65 years

47

31 (65.96)

0.807 (0.242-2.694)

Age (late elderly)

 < 75 years

50

31 (62.00)

Reference

 ≥ 75 years

14

12 (85.71)

3.677 (0.741-18.251)

Disease duration category

 < 4 weeks

3

2 (66.67)

Reference

 ≥ 4 weeks to < 26 weeks

21

15 (71.43)

1.250 (0.095-16.503)

 ≥ 26 weeks to < 52 weeks

8

6 (75.00)

1.500 (0.084-26.849)

 ≥ 52 weeks to  < 156 weeks

12

9 (75.00)

1.500 (0.098-23.064)

 ≥ 156 weeks

17

9 (52.94)

0.562 (0.043-7.441)

 Unknown/not specified

3

2 (66.67)

–

Medical history

 No

41

27 (65.85)

Reference

 Yes

23

16 (69.57)

1.185 (0.395-3.553)

Comorbidity

 No

21

16 (76.19)

Reference

 Yes

43

27 (62.79)

0.527 (0.162-1.715)

Comorbidity: renal impairment

 No

63

42 (66.67)

Reference

 Yes

1

1 (100.00)

> 999.999 (< 0.001 to > 999.999)

Comorbidity: cardiac disorders

 No

60

39 (65.00)

Reference

 Yes

4

4 (100.00)

> 999.999 (< 0.001 to > 999.999)

Comorbidity: other

 No

21

16 (76.19)

-

 Yes

43

27 (62.79)

ECOG performance status

 0–2

62

42 (67.74)

Reference

 ≥ 3

2

1 (50.00)

0.476 (0.028-8.009)

Lung cancer staging classification

 Stage I

0

-

-

 Stage II

1

1 (100.00)

> 999.999 (< 0.001 to > 999.999)

 Stage IIIA

3

2 (66.67)

1.059 (0.090-12.487)

 Stage IIIB

7

5 (71.43)

1.324 (0.233-7.514)

 Stage IIIC

0

-

-

 Stage IV

52

34 (65.38)

Reference

 Unknown/not specified

1

1 (100.00)

-

Histology

 Large cell carcinoma

0

-

-

 Squamous cell carcinoma

1

1 (100.00)

> 999.999 (< 0.001 to > 999.999)

 Adenocarcinoma

59

39 (66.10)

Reference

 Pleomorphic carcinoma

1

1 (100.00)

> 999.999 (< 0.001 to > 999.999)

 Other

3

2 (66.67)

1.026 (0.088-12.008)

Brain metastases

 No

54

36 (66.67)

Reference

 Yes

10

7 (70.00)

1.167 (0.269-5.054)

Smoking history

 Never smoked

16

11 68.75)

Reference

 Former smoker

41

28 (68.29)

0.979 (0.282-3.400)

 Current smoker

5

3 (60.00)

0.682 (0.085-5.447)

 Unknown/not specified

2

1 (50.00)

-

Number of lines of therapy used before the start of DAB/TRA treatment

 0

18

14 (77.78)

Reference

 ≥ 1

45

28 (62.22)

0.471 (0.133-1.666)

 Unknown/not specified

1

1 (100.00)

-

Prior surgery for primary diagnosis

 No

46

29 (63.04)

Reference

 Yes

18

14 (77.78)

2.052 (0.581-7.249)

Prior radiotherapy for primary diagnosis

 No

45

30 (66.67)

Reference

 Yes

19

13 (68.42)

1.083 (0.343-3.417)

Prior treatment for primary disease

 No

18

14 (77.78)

Reference

 Yes

46

29 (63.04)

0.487 (0.138-1.722)

Prior ICI medication immediately before DAB/TRA administration

 No

51

34 (66.67)

Reference

 Yes

13

9 (69.23)

1.125 (0.3024.185)