Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07291037

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

Led by AstraZeneca · Updated on 2026-04-29

400

Participants Needed

204

Research Sites

169 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

D

Daiichi Sankyo

Collaborating Sponsor

AI-Summary

What this Trial Is About

TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).

CONDITIONS

Official Title

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Stage IIIB, IIIC, or IV non-squamous NSCLC without actionable genomic alterations
  • Negative tests for EGFR, ALK, ROS1, NTRK, BRAF, RET, MET exon 14 skipping, KRAS G12C, HER2, or other targetable mutations
  • Positive for TROP2 protein by normalized membrane ratio
  • Radiographic disease progression after most recent treatment for advanced or metastatic NSCLC
  • Prior treatment with platinum-based chemotherapy plus anti-PD-1/PD-L1 antibody as one or two prior therapy lines
  • Provide acceptable tumor tissue sample for TROP2 assessment
  • At least one measurable lesion not previously irradiated, suitable for repeated imaging measurements
  • ECOG performance status of 0 or 1
  • Adequate bone marrow and organ function within 7 days before randomization
Not Eligible

You will not qualify if you...

  • Squamous, mixed NSCLC, or small cell lung cancer histology
  • NSCLC eligible for only local therapy
  • History of other primary malignancy except if treated curatively and no active disease for 3 years
  • Spinal cord compression or brain metastases unless stable, asymptomatic, and off steroids or anticonvulsants for 7 days
  • Clinically significant corneal disease
  • Active or uncontrolled hepatitis B or C infection
  • Known HIV infection not well controlled
  • Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
  • History or current interstitial lung disease or pneumonitis requiring steroids or suspected but not ruled out by imaging
  • Severe lung function compromise as decided by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 204 locations

1

Research Site

Chandler, Arizona, United States, 85224

Actively Recruiting

2

Research Site

Gilbert, Arizona, United States, 85234

Actively Recruiting

3

Research Site

Goodyear, Arizona, United States, 85338

Actively Recruiting

4

Research Site

Duarte, California, United States, 91010

Actively Recruiting

5

Research Site

Irvine, California, United States, 92618

Actively Recruiting

6

Research Site

La Jolla, California, United States, 92093

Actively Recruiting

7

Research Site

Loma Linda, California, United States, 92350

Actively Recruiting

8

Research Site

Los Angeles, California, United States, 90095

Not Yet Recruiting

9

Research Site

San Diego, California, United States, 92123

Actively Recruiting

10

Research Site

Grand Junction, Colorado, United States, 81501

Actively Recruiting

11

Research Site

Wheat Ridge, Colorado, United States, 80033

Actively Recruiting

12

Research Site

Newark, Delaware, United States, 19713

Not Yet Recruiting

13

Research Site

Washington D.C., District of Columbia, United States, 20037

Not Yet Recruiting

14

Research Site

Fort Myers, Florida, United States, 33901

Not Yet Recruiting

15

Research Site

Jacksonville, Florida, United States, 32224

Actively Recruiting

16

Research Site

St. Petersburg, Florida, United States, 33709

Actively Recruiting

17

Research Site

Tampa, Florida, United States, 33612

Actively Recruiting

18

Research Site

West Palm Beach, Florida, United States, 33401

Not Yet Recruiting

19

Research Site

Marietta, Georgia, United States, 30060

Actively Recruiting

20

Research Site

Newnan, Georgia, United States, 30265

Actively Recruiting

21

Research Site

Chicago, Illinois, United States, 60612

Not Yet Recruiting

22

Research Site

Chicago, Illinois, United States, 60637

Actively Recruiting

23

Research Site

Niles, Illinois, United States, 60714

Actively Recruiting

24

Research Site

Zion, Illinois, United States, 60099

Actively Recruiting

25

Research Site

Louisville, Kentucky, United States, 40207

Actively Recruiting

26

Research Site

South Portland, Maine, United States, 04106

Not Yet Recruiting

27

Research Site

Baltimore, Maryland, United States, 21201

Actively Recruiting

28

Research Site

Brandywine, Maryland, United States, 20613

Actively Recruiting

29

Research Site

Boston, Massachusetts, United States, 02215

Actively Recruiting

30

Research Site

Detroit, Michigan, United States, 48202

Actively Recruiting

31

Research Site

Rochester, Minnesota, United States, 55905

Actively Recruiting

32

Research Site

Bridgeton, Missouri, United States, 63044

Actively Recruiting

33

Research Site

Columbia, Missouri, United States, 65212

Withdrawn

34

Research Site

Lincoln, Nebraska, United States, 68516

Actively Recruiting

35

Research Site

Albuquerque, New Mexico, United States, 87109

Actively Recruiting

36

Research Site

East Syracuse, New York, United States, 13057

Actively Recruiting

37

Research Site

Portland, Oregon, United States, 97239

Withdrawn

38

Research Site

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

39

Research Site

Philadelphia, Pennsylvania, United States, 19104

Not Yet Recruiting

40

Research Site

Greenville, South Carolina, United States, 29607

Actively Recruiting

41

Research Site

Memphis, Tennessee, United States, 38120

Actively Recruiting

42

Research Site

Austin, Texas, United States, 78745

Actively Recruiting

43

Research Site

Denton, Texas, United States, 76201

Actively Recruiting

44

Research Site

Plano, Texas, United States, 75075

Actively Recruiting

45

Research Site

Charlottesville, Virginia, United States, 22908

Actively Recruiting

46

Research Site

Fairfax, Virginia, United States, 22031

Actively Recruiting

47

Research Site

Williamsburg, Virginia, United States, 23188

Actively Recruiting

48

Research Site

Tacoma, Washington, United States, 98405

Actively Recruiting

49

Research Site

Morgantown, West Virginia, United States, 26506

Actively Recruiting

50

Research Site

Eau Claire, Wisconsin, United States, 54703

Actively Recruiting

51

Research Site

Gosford, Australia, 2250

Actively Recruiting

52

Research Site

Kogarah, Australia, 2217

Actively Recruiting

53

Research Site

South Brisbane, Australia, 4101

Actively Recruiting

54

Research Site

St Albans, Australia, 3021

Actively Recruiting

55

Research Site

Wollongong, Australia, 2500

Actively Recruiting

56

Research Site

Graz, Austria, 8036

Not Yet Recruiting

57

Research Site

Linz, Austria, 4021

Not Yet Recruiting

58

Research Site

Rankweil, Austria, 6830

Actively Recruiting

59

Research Site

Vienna, Austria, 1140

Not Yet Recruiting

60

Research Site

Vienna, Austria, 1210

Actively Recruiting

61

Research Site

Hasselt, Belgium, 3500

Not Yet Recruiting

62

Research Site

La Louvière, Belgium, 7100

Not Yet Recruiting

63

Research Site

Libramont-Chevigny, Belgium, 6800

Not Yet Recruiting

64

Research Site

Namur, Belgium, 5000

Not Yet Recruiting

65

Research Site

Sint-Niklaas, Belgium, 9100

Not Yet Recruiting

66

Research Site

Porto Alegre, Brazil, 90610-000

Actively Recruiting

67

Research Site

Porto Alegre, Brazil, 91350-200

Actively Recruiting

68

Research Site

Salvador, Brazil, 40170-110

Actively Recruiting

69

Research Site

São Paulo, Brazil, 01246-000

Actively Recruiting

70

Research Site

São Paulo, Brazil, 01327-001

Actively Recruiting

71

Research Site

São Paulo, Brazil, 05652-900

Actively Recruiting

72

Research Site

Vancouver, British Columbia, Canada, VSZ 4E6

Actively Recruiting

73

Research Site

Moncton, New Brunswick, Canada, E1C 6Z8

Actively Recruiting

74

Research Site

Halifax, Nova Scotia, Canada, B3H 2Y9

Actively Recruiting

75

Research Site

Brampton, Ontario, Canada, L6R 3J7

Actively Recruiting

76

Research Site

Hamilton, Ontario, Canada, L8V 1C3

Actively Recruiting

77

Research Site

Toronto, Ontario, Canada, M5G 1X6

Actively Recruiting

78

Research Site

Beijing, China, 100034

Actively Recruiting

79

Research Site

Beijing, China, 100142

Actively Recruiting

80

Research Site

Beijing, China, 101149

Actively Recruiting

81

Research Site

Changchun, China, 130000

Actively Recruiting

82

Research Site

Changsha, China, 410013

Actively Recruiting

83

Research Site

Chengdu, China, 610041

Actively Recruiting

84

Research Site

Chengdu, China, 610072

Actively Recruiting

85

Research Site

Chongqing, China, 400030

Actively Recruiting

86

Research Site

Fuzhou, China, 350011

Actively Recruiting

87

Research Site

Guangzhou, China, 510080

Actively Recruiting

88

Research Site

Hangzhou, China, 310022

Actively Recruiting

89

Research Site

Harbin, China, 150081

Actively Recruiting

90

Research Site

Hefei, China, 230610

Actively Recruiting

91

Research Site

Jiamusi, China, 154007

Actively Recruiting

92

Research Site

Jinan, China, 250117

Actively Recruiting

93

Research Site

Nanchang, China, 330006

Actively Recruiting

94

Research Site

Nanjing, China, 2100008

Actively Recruiting

95

Research Site

Shanghai, China, 200030

Actively Recruiting

96

Research Site

Shanghai, China, 200032

Not Yet Recruiting

97

Research Site

Shanghai, China, 200433

Actively Recruiting

98

Research Site

Shantou, China, 515041

Actively Recruiting

99

Research Site

Shenyang, China, 110004

Actively Recruiting

100

Research Site

Tianjin, China, 300050

Actively Recruiting

101

Research Site

Wuhan, China, 430030

Withdrawn

102

Research Site

Wuhan, China, 430060

Actively Recruiting

103

Research Site

Xuzhou, China, 221009

Withdrawn

104

Research Site

Zhengzhou, China, 450008

Actively Recruiting

105

Research Site

Zhengzhou, China, 450052

Actively Recruiting

106

Research Site

Boulogne-Billancourt, France, 92104

Not Yet Recruiting

107

Research Site

Lyon, France, 69008

Not Yet Recruiting

108

Research Site

Marseille, France, 13915

Not Yet Recruiting

109

Research Site

Saint-Herblain, France, 44800

Not Yet Recruiting

110

Research Site

Toulouse, France, 31400

Not Yet Recruiting

111

Research Site

Bad Saarow, Germany, 15526

Not Yet Recruiting

112

Research Site

Bielefeld, Germany, 33611

Not Yet Recruiting

113

Research Site

Bonn, Germany, 53127

Not Yet Recruiting

114

Research Site

Cologne, Germany, 51109

Not Yet Recruiting

115

Research Site

Essen, Germany, 45147

Not Yet Recruiting

116

Research Site

Frankfurt, Germany, 60488

Not Yet Recruiting

117

Research Site

Freiburg im Breisgau, Germany, 79106

Withdrawn

118

Research Site

Gauting, Germany, 82131

Not Yet Recruiting

119

Research Site

Hamburg, Germany, 20251

Not Yet Recruiting

120

Research Site

Heidelberg, Germany, 69126

Not Yet Recruiting

121

Research Site

Krefeld, Germany, 47805

Not Yet Recruiting

122

Research Site

Minden, Germany, 32429

Not Yet Recruiting

123

Research Site

Oldenburg, Germany, 26121

Not Yet Recruiting

124

Research Site

Stuttgart, Germany, 70174

Not Yet Recruiting

125

Research Site

Troisdorf, Germany, 53840

Not Yet Recruiting

126

Research Site

Velbert, Germany, 42551

Not Yet Recruiting

127

Research Site

Budapest, Hungary, 1083

Not Yet Recruiting

128

Research Site

Budapest, Hungary, 1121

Not Yet Recruiting

129

Research Site

Budapest, Hungary, 1145

Not Yet Recruiting

130

Research Site

Debrecen, Hungary, 4032

Not Yet Recruiting

131

Research Site

Gyöngyös - Mátraháza, Hungary, 3200

Not Yet Recruiting

132

Research Site

Győr, Hungary, 9024

Not Yet Recruiting

133

Research Site

Gyula, Hungary, 5700

Not Yet Recruiting

134

Research Site

Kecskemét, Hungary, 6000

Not Yet Recruiting

135

Research Site

Szolnok, Hungary, 5000

Not Yet Recruiting

136

Research Site

Törökbálint, Hungary, 2045

Not Yet Recruiting

137

Research Site

Bangalore, India, 560027

Actively Recruiting

138

Research Site

Kolkata, India, 700016

Actively Recruiting

139

Research Site

Mumbai, India, 400012

Actively Recruiting

140

Research Site

Nashik, India, 422011

Actively Recruiting

141

Research Site

New Delhi, India, 11029

Actively Recruiting

142

Research Site

Milan, Italy, 20141

Not Yet Recruiting

143

Research Site

Milan, Italy, 20162

Not Yet Recruiting

144

Research Site

Monza, Italy, 20052

Not Yet Recruiting

145

Research Site

Orbassano, Italy, 10043

Not Yet Recruiting

146

Research Site

Padova, Italy, 35128

Not Yet Recruiting

147

Research Site

Rozzano, Italy, 20089

Not Yet Recruiting

148

Research Site

Chūōku, Japan, 104-0045

Actively Recruiting

149

Research Site

Fukuoka, Japan, 812-8582

Actively Recruiting

150

Research Site

Hiroshima, Japan, 734-8551

Actively Recruiting

151

Research Site

Iwakuni-shi, Japan, 740-8510

Actively Recruiting

152

Research Site

Kashiwa, Japan, 277-8577

Not Yet Recruiting

153

Research Site

Kawasaki-shi, Japan, 216-8511

Actively Recruiting

154

Research Site

Kyoto, Japan, 612-8555

Actively Recruiting

155

Research Site

Matsuyama, Japan, 791-0280

Actively Recruiting

156

Research Site

Nagoya, Japan, 464-8681

Actively Recruiting

157

Research Site

Niigata, Japan, 951-8566

Actively Recruiting

158

Research Site

Osaka, Japan, 541-8567

Actively Recruiting

159

Research Site

Osakasayama-shi, Japan, 589-8511

Actively Recruiting

160

Research Site

Sendai, Japan, 981-0914

Actively Recruiting

161

Research Site

Sunto-gun, Japan, 411-8777

Actively Recruiting

162

Research Site

Yokohama, Japan, 241-8515

Actively Recruiting

163

Research Site

Lodz, Poland, 93-338

Not Yet Recruiting

164

Research Site

Olsztyn, Poland, 10-357

Not Yet Recruiting

165

Research Site

Poznan, Poland, 60-569

Not Yet Recruiting

166

Research Site

Warsaw, Poland, 02-781

Not Yet Recruiting

167

Research Site

Goyang-si, South Korea, 10408

Actively Recruiting

168

Research Site

Incheon, South Korea, 21565

Actively Recruiting

169

Research Site

Seoul, South Korea, 03722

Actively Recruiting

170

Research Site

Seoul, South Korea, 06351

Actively Recruiting

171

Research Site

Seoul, South Korea, 5505

Actively Recruiting

172

Research Site

Suwon, South Korea, 16247

Actively Recruiting

173

Research Site

A Coruña, Spain, 15009

Not Yet Recruiting

174

Research Site

Barcelona, Spain, 8035

Not Yet Recruiting

175

Research Site

L'Hospitalet de Llobregat, Spain, 08908

Not Yet Recruiting

176

Research Site

Madrid, Spain, 28041

Not Yet Recruiting

177

Research Site

Málaga, Spain, 29010

Not Yet Recruiting

178

Research Site

Seville, Spain, 41009

Not Yet Recruiting

179

Research Site

Zaragoza, Spain, 50009

Not Yet Recruiting

180

Research Site

Kaohsiung City, Taiwan, 80756

Actively Recruiting

181

Research Site

Taichung, Taiwan, 40705

Actively Recruiting

182

Research Site

Tainan, Taiwan, 73657

Actively Recruiting

183

Research Site

Taipei, Taiwan, 10002

Actively Recruiting

184

Research Site

Taipei, Taiwan, 11217

Actively Recruiting

185

Research Site

Taipei, Taiwan, 11490

Actively Recruiting

186

Research Site

Taoyuan, Taiwan, 333

Actively Recruiting

187

Research Site

Bangkok, Thailand, 10210

Actively Recruiting

188

Research Site

Bangkok, Thailand, 10300

Actively Recruiting

189

Research Site

Bangkok, Thailand, 10700

Actively Recruiting

190

Research Site

Hat Yai, Thailand, 90110

Actively Recruiting

191

Research Site

Muang, Thailand, 50200

Actively Recruiting

192

Research Site

Ankara, Turkey (Türkiye), 06530

Actively Recruiting

193

Research Site

Istanbul, Turkey (Türkiye), 32098

Actively Recruiting

194

Research Site

Huddersfield, United Kingdom, HD3 3EA

Actively Recruiting

195

Research Site

London, United Kingdom, SE1 9RT

Not Yet Recruiting

196

Research Site

London, United Kingdom, SW10 9NH

Not Yet Recruiting

197

Research Site

London, United Kingdom, SW170QT

Actively Recruiting

198

Research Site

Maidstone, United Kingdom, ME16 9QQ

Withdrawn

199

Research Site

Norwich, United Kingdom, NR4 7UY

Actively Recruiting

200

Research Site

Stoke-on-Trent, United Kingdom, ST4 6QG

Not Yet Recruiting

201

Research Site

Hanoi, Vietnam, 100000

Actively Recruiting

202

Research Site

Ho Chi Minh City, Vietnam, 700000

Actively Recruiting

203

Research Site

Ho Chi Minh City, Vietnam, 70000

Actively Recruiting

204

Research Site

Vinh, Vietnam, 460000

Actively Recruiting

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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