Actively Recruiting
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
Led by AstraZeneca · Updated on 2026-05-06
582
Participants Needed
166
Research Sites
382 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate efficacy and safety of osimertinib (tablet) in combination with Dato-DXd (i.v. infusion) compared with osimertinib (tablet) monotherapyas a first-line therapy in participants with locally advanced or metastatic EGFRm (Ex19del and/or L858R) NSCLC. Study details include: 1. The study duration will be event-driven, with an estimated duration of approximately 8 years. 2. Participants may receive study treatment until disease progression, unacceptable toxicity, or other specific discontinuation criteria are met. 3. The visit frequency will be every 3 weeks during the treatment period. Note: Participants on osimertinib treatment(osimertinib only arm or who have discontinued Dato-DXd while are still receiving osimertinib) are required to attend visits to perform assessments every 6 weeks from Cycle 7 until Cycle 17 and then visits every 12 weeks until disease progression or IP discontinuation. Participants who are receiving osimertinib + Dato-DXd are still required to attend visit to perform assessment every 3 weeks (q3w) per SoA.
CONDITIONS
Official Title
Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years or older.
- Histologically or cytologically confirmed nonsquamous NSCLC; mixed histology allowed if adenocarcinoma is predominant.
- Stage IIIB, IIIC, IV metastatic, or recurrent NSCLC not suitable for curative surgery or chemoradiation.
- No prior EGFR tyrosine kinase inhibitors or systemic therapy for advanced NSCLC.
- Tumor harbors at least one common EGFR mutation (Ex19del or L858R) assessed by certified laboratory.
- Provision of unstained archival tumor tissue for central EGFR mutation confirmation during randomization.
- WHO performance status of 0 or 1.
- At least one measurable lesion not previously irradiated, suitable for repeated measurement.
- Adequate bone marrow and organ function before first study treatment dose.
You will not qualify if you...
- Presence of severe or uncontrolled systemic diseases or conditions that could interfere with study participation.
- Chronic gastrointestinal disorders or inability to swallow osimertinib.
- History of another primary cancer.
- Spinal cord compression or unstable brain metastases.
- Clinically significant corneal disease.
- Active or uncontrolled hepatitis B or C infection.
- History or suspicion of interstitial lung disease or pneumonitis.
- Recent pulmonary embolism within 3 months or severe pulmonary function impairment due to other illnesses.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 166 locations
1
Research Site
Fountain Valley, California, United States, 92708
Suspended
2
Research Site
Los Alamitos, California, United States, 90720
Actively Recruiting
3
Research Site
Los Angeles, California, United States, 90017
Actively Recruiting
4
Research Site
Los Angeles, California, United States, 90033
Actively Recruiting
5
Research Site
Orange, California, United States, 92868
Not Yet Recruiting
6
Research Site
San Diego, California, United States, 92123
Actively Recruiting
7
Research Site
Santa Monica, California, United States, 90404
Actively Recruiting
8
Research Site
Walnut Creek, California, United States, 94598
Actively Recruiting
9
Research Site
New Haven, Connecticut, United States, 06510
Actively Recruiting
10
Research Site
Washington D.C., District of Columbia, United States, 20037
Withdrawn
11
Research Site
Jacksonville, Florida, United States, 32256
Actively Recruiting
12
Research Site
Ocala, Florida, United States, 34474
Actively Recruiting
13
Research Site
Orange City, Florida, United States, 32763
Actively Recruiting
14
Research Site
Honolulu, Hawaii, United States, 96819
Withdrawn
15
Research Site
Chicago, Illinois, United States, 60611
Withdrawn
16
Research Site
Hinsdale, Illinois, United States, 60521
Actively Recruiting
17
Research Site
North Chicago, Illinois, United States, 60064
Actively Recruiting
18
Research Site
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
19
Research Site
Bethesda, Maryland, United States, 20817
Actively Recruiting
20
Research Site
Detroit, Michigan, United States, 48201
Actively Recruiting
21
Research Site
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
22
Research Site
Bridgeton, Missouri, United States, 63044
Withdrawn
23
Research Site
St Louis, Missouri, United States, 63110
Actively Recruiting
24
Research Site
Las Vegas, Nevada, United States, 89169
Actively Recruiting
25
Research Site
Brooklyn, New York, United States, 11212
Not Yet Recruiting
26
Research Site
New York, New York, United States, 10065
Actively Recruiting
27
Research Site
Dallas, Texas, United States, 75390
Withdrawn
28
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
29
Research Site
Houston, Texas, United States, 77090
Withdrawn
30
Research Site
Webster, Texas, United States, 77598
Actively Recruiting
31
Research Site
Woodway, Texas, United States, 76712
Actively Recruiting
32
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
33
Research Site
Fort Belvoir, Virginia, United States, 22060
Actively Recruiting
34
Research Site
Midlothian, Virginia, United States, 23114
Actively Recruiting
35
Research Site
Seattle, Washington, United States, 98104
Withdrawn
36
Research Site
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
37
Research Site
Camperdown, Australia, 2050
Actively Recruiting
38
Research Site
Clayton, Australia, 3168
Actively Recruiting
39
Research Site
Kogarah, Australia, 2217
Actively Recruiting
40
Research Site
South Brisbane, Australia, 4101
Actively Recruiting
41
Research Site
Westmead, Australia, 2145
Actively Recruiting
42
Research Site
Barretos, Brazil, 14784-400
Actively Recruiting
43
Research Site
Natal, Brazil, 59075-740
Actively Recruiting
44
Research Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
45
Research Site
Salvador, Brazil, 41253-190
Actively Recruiting
46
Research Site
São Paulo, Brazil, 01246-000
Actively Recruiting
47
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
48
Research Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
49
Research Site
Beijing, China, 100029
Actively Recruiting
50
Research Site
Beijing, China, 100034
Actively Recruiting
51
Research Site
Beijing, China, 100142
Actively Recruiting
52
Research Site
Changchun, China, 130000
Actively Recruiting
53
Research Site
Changsha, China, 410013
Actively Recruiting
54
Research Site
Chengdu, China, 610000
Actively Recruiting
55
Research Site
Chengdu, China, 610042
Actively Recruiting
56
Research Site
Chengdu, China, 610072
Actively Recruiting
57
Research Site
Chongqing, China, 400030
Actively Recruiting
58
Research Site
Chongqing, China, 402260
Actively Recruiting
59
Research Site
Guangzhou, China, 510100
Actively Recruiting
60
Research Site
Hangzhou, China, 310006
Actively Recruiting
61
Research Site
Hangzhou, China, 31000
Actively Recruiting
62
Research Site
Hangzhou, China, 310022
Actively Recruiting
63
Research Site
Harbin, China, 150049
Actively Recruiting
64
Research Site
Hefei, China, 230031
Actively Recruiting
65
Research Site
Hefei, China, 230601
Actively Recruiting
66
Research Site
Jinan, China, 250021
Actively Recruiting
67
Research Site
Jinan, China, 250117
Actively Recruiting
68
Research Site
Kunming, China, 650118
Actively Recruiting
69
Research Site
Linhai, China, 317000
Actively Recruiting
70
Research Site
Ningbo, China, 315010
Actively Recruiting
71
Research Site
Shanghai, China, 200030
Actively Recruiting
72
Research Site
Shanghai, China, 200433
Actively Recruiting
73
Research Site
Shenyang, China, 110004
Actively Recruiting
74
Research Site
Wenzhou, China, 325000
Actively Recruiting
75
Research Site
Wuhan, China, 430022
Actively Recruiting
76
Research Site
Wuhan, China, 430030
Actively Recruiting
77
Research Site
Xi'an, China, 710061
Actively Recruiting
78
Research Site
Xuzhou, China, 221000
Actively Recruiting
79
Research Site
Yangzhou, China, 225001
Actively Recruiting
80
Research Site
Zhengzhou, China, 450000
Actively Recruiting
81
Research Site
Zhengzhou, China, 450008
Actively Recruiting
82
Research Site
Angers, France, 49055
Actively Recruiting
83
Research Site
Marseille, France, 13915
Actively Recruiting
84
Research Site
Paris, France, 75005
Actively Recruiting
85
Research Site
Strasbourg, France, 67091, Cedex
Actively Recruiting
86
Research Site
Berlin, Germany, 13125
Actively Recruiting
87
Research Site
Cologne, Germany, 51109
Actively Recruiting
88
Research Site
Erfurt, Germany, 99089
Actively Recruiting
89
Research Site
Frankfurt, Germany, 60488
Actively Recruiting
90
Research Site
Göttingen, Germany, 37075
Withdrawn
91
Research Site
Immenhausen, Germany, 34376
Actively Recruiting
92
Research Site
Kiel, Germany, 24105
Actively Recruiting
93
Research Site
Mainz, Germany, 55131
Actively Recruiting
94
Research Site
München, Germany, 81925
Actively Recruiting
95
Research Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
96
Research Site
Hong Kong, Hong Kong
Not Yet Recruiting
97
Research Site
Jordan, Hong Kong, 999077
Actively Recruiting
98
Research Site
Lai Chi Kok, Hong Kong
Not Yet Recruiting
99
Research Site
Bangalore, India, 560027
Actively Recruiting
100
Research Site
Delhi, India, 110085
Withdrawn
101
Research Site
Hyderabad, India, 500032
Actively Recruiting
102
Research Site
Kolkata, India, 700054
Withdrawn
103
Research Site
Mysuru, India, 570017
Suspended
104
Research Site
Nagpur, India, 440001
Withdrawn
105
Research Site
Nashik, India, 422011
Actively Recruiting
106
Research Site
New Delhi, India, 100049
Withdrawn
107
Research Site
New Delhi, India, 11029
Actively Recruiting
108
Research Site
Vadodara, India, 391760
Actively Recruiting
109
Research Site
Varanasi, India, 221005
Withdrawn
110
Research Site
Milan, Italy, 20141
Actively Recruiting
111
Research Site
Monza, Italy, 20900
Actively Recruiting
112
Research Site
Orbassano, Italy, 10043
Actively Recruiting
113
Research Site
Padova, Italy, 35128
Actively Recruiting
114
Research Site
Parma, Italy, 43100
Actively Recruiting
115
Research Site
Chūōku, Japan, 104-0045
Actively Recruiting
116
Research Site
Fukuoka, Japan, 812-8582
Actively Recruiting
117
Research Site
Kashiwa, Japan, 277-8577
Actively Recruiting
118
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
119
Research Site
Niigata, Japan, 951-8566
Actively Recruiting
120
Research Site
Osaka, Japan, 541-8567
Actively Recruiting
121
Research Site
Sakai, Japan, 590-0197
Actively Recruiting
122
Research Site
Sapporo, Japan, 003-0804
Actively Recruiting
123
Research Site
Sendai, Japan, 981-0914
Actively Recruiting
124
Research Site
Wakayama, Japan, 641-8510
Actively Recruiting
125
Research Site
Yokohama, Japan, 241-8515
Actively Recruiting
126
Research Site
Bystra, Poland, 43-360
Actively Recruiting
127
Research Site
Olsztyn, Poland, 10-357
Actively Recruiting
128
Research Site
Poznan, Poland, 60-569
Actively Recruiting
129
Research Site
Warsaw, Poland, 02-781
Actively Recruiting
130
Research Site
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
131
Research Site
San Juan, Puerto Rico, 00918
Actively Recruiting
132
Research Site
Goyang-si, South Korea, 410-769
Actively Recruiting
133
Research Site
Namdong-gu, South Korea, 21565
Actively Recruiting
134
Research Site
Seoul, South Korea, 03080
Actively Recruiting
135
Research Site
Seoul, South Korea, 06351
Actively Recruiting
136
Research Site
Seoul, South Korea, 120-752
Actively Recruiting
137
Research Site
Suwon, South Korea, 16247
Actively Recruiting
138
Research Site
A Coruña, Spain, 15006
Actively Recruiting
139
Research Site
Barcelona, Spain, 8036
Actively Recruiting
140
Research Site
Granada, Spain, 18007
Actively Recruiting
141
Research Site
Madrid, Spain, 28040
Actively Recruiting
142
Research Site
Majadahonda, Spain, 28222
Actively Recruiting
143
Research Site
Valencia, Spain, 46009
Actively Recruiting
144
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
145
Research Site
Tainan, Taiwan, 704
Actively Recruiting
146
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
147
Research Site
Taipei, Taiwan, 106
Actively Recruiting
148
Research Site
Taipei, Taiwan, TAIWAN
Actively Recruiting
149
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
150
Research Site
Bangkok, Thailand, 10400
Active, Not Recruiting
151
Research Site
Bangkok, Thailand, 10700
Active, Not Recruiting
152
Research Site
Dusit, Thailand, 10300
Active, Not Recruiting
153
Research Site
Hat Yai, Thailand, 90110
Actively Recruiting
154
Research Site
Udon Thani, Thailand, 41000
Active, Not Recruiting
155
Research Site
Adapazarı, Turkey (Türkiye), 54100
Actively Recruiting
156
Research Site
Ankara, Turkey (Türkiye), 06530
Actively Recruiting
157
Research Site
Goztepe Istanbul, Turkey (Türkiye)
Withdrawn
158
Research Site
Izmir, Turkey (Türkiye), 35100
Withdrawn
159
Research Site
Küçükçekmece, Turkey (Türkiye), 34295
Actively Recruiting
160
Research Site
Seyhan, Turkey (Türkiye), 1060
Actively Recruiting
161
Research Site
Hanoi, Vietnam, 100000
Active, Not Recruiting
162
Research Site
Hà Nội, Vietnam, 100000
Active, Not Recruiting
163
Research Site
Ho Chi Minh City, Vietnam, 700000
Active, Not Recruiting
164
Research Site
Ho Chi Minh City, Vietnam, 70000
Active, Not Recruiting
165
Research Site
Ho Chi Minh City, Vietnam
Active, Not Recruiting
166
Research Site
Vinh, Vietnam, 460000
Active, Not Recruiting
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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