Phase III Global Study of Datopotamab Deruxtecan with Rilvegostomig or Rilvegostomig Alone Versus Pembrolizumab Alone as First-Line Treatment for Advanced Non-squamous NSCLC with High PD-L1 Expression and No Actionable Genomic Alterations
Led by AstraZeneca · Updated on 2026-05-18
675
Participants Needed
281
Research Sites
N/A
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
Sponsors
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with rilvegostomig or rilvegostomig alone, compared to pembrolizumab alone, as first-line treatments for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have high PD-L1 expression (tumor cell 50% or greater) and no actionable genomic alterations. This Phase III, randomized, open-label global study aims to improve treatment options for this patient group.
Participants will be randomly assigned to one of three groups: one receiving Dato-DXd plus rilvegostomig, another receiving rilvegostomig alone, and the third receiving pembrolizumab alone. All treatments are given as intravenous infusions every three weeks on the first day of each 21-day cycle. The study compares these therapies to see which is more effective and safe as a first-line treatment.
During the study, participants will undergo regular assessments including tumor evaluations, biomarker testing, and symptom questionnaires. Researchers will monitor progression-free survival and overall survival over approximately four to six years, along with other measures such as response rate, duration of response, physical functioning, and quality of life. Safety and pharmacokinetics will also be evaluated to understand how the treatments affect participants over the long term.
CONDITIONS
Brief Title
Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Histologically or cytologically confirmed non-squamous NSCLC
Stage IIIB, IIIC, or IV metastatic NSCLC not suitable for curative surgery or definitive chemoradiation
No sensitising EGFR mutations, ALK or ROS1 rearrangements, or other actionable genomic alterations with approved targeted therapies
Must provide tumor sample for PD-L1, TROP2, and other biomarker testing
Tumor PD-L1 expression of 50% or greater
At least one lesion qualifying as a RECIST 1.1 target lesion that has not been previously irradiated
ECOG performance status of 0 or 1
Adequate bone marrow and organ function
You will not qualify if you...
Prior systemic therapy for advanced or metastatic NSCLC
Squamous or predominantly squamous NSCLC histology, mixed small cell lung cancer, or sarcomatoid variant
History of another primary cancer within 3 years
Active or prior autoimmune or inflammatory disorders (with some exceptions)
Severe or uncontrolled disease making participation unsafe or causing noncompliance
Clinically significant fluid retention not suitable for drainage
History or current evidence of interstitial lung disease or pneumonitis not ruled out
Significant pulmonary function impairment
Spinal cord compression or symptomatic brain metastases unless treated, stable, and off steroids or anticonvulsants
History of leptomeningeal carcinomatosis
Significant corneal disease
Active infections such as TB, hepatitis B, hepatitis C, hepatitis A, or uncontrolled HIV
History of active primary immunodeficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 6 years
Participants receive intravenous infusions of study drugs every 3 weeks as first-line treatment for advanced non-squamous NSCLC with high PD-L1 expression.
Infusions every 3 weeks on Day 1 of each 21-day cycle
Trial Site Locations
Total: 281 locations
1
Research Site
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Research Site
Tucson, Arizona, United States, 85719
Actively Recruiting
3
Research Site
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
Research Site
Springdale, Arkansas, United States, 72762
Actively Recruiting
5
Research Site
Anaheim, California, United States, 92801
Actively Recruiting
6
Research Site
Beverly Hills, California, United States, 90211
Actively Recruiting
7
Research Site
Fountain Valley, California, United States, 92708
Actively Recruiting
8
Research Site
Newport Beach, California, United States, 92663
Suspended
9
Research Site
Clermont, Florida, United States, 34711
Actively Recruiting
10
Research Site
Gainesville, Florida, United States, 32608
Actively Recruiting
11
Research Site
Miami Beach, Florida, United States, 33140
Actively Recruiting
12
Research Site
Orange City, Florida, United States, 32763
Actively Recruiting
13
Research Site
Orlando, Florida, United States, 32806
Actively Recruiting
14
Research Site
Orlando, Florida, United States, 32827
Withdrawn
15
Research Site
West Palm Beach, Florida, United States, 33401
Actively Recruiting
16
Research Site
Atlanta, Georgia, United States, 30303
Suspended
17
Research Site
Atlanta, Georgia, United States, 30318
Actively Recruiting
18
Research Site
Atlanta, Georgia, United States, 30322
Actively Recruiting
19
Research Site
Atlanta, Georgia, United States, 30342
Withdrawn
20
Research Site
Hinsdale, Illinois, United States, 60521
Actively Recruiting
21
Research Site
Noblesville, Indiana, United States, 46062
Actively Recruiting
22
Research Site
Paducah, Kentucky, United States, 42003
Not Yet Recruiting
23
Research Site
Annapolis, Maryland, United States, 21401
Actively Recruiting
24
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
Research Site
Boston, Massachusetts, United States, 02215
Actively Recruiting
26
Research Site
Dearborn, Michigan, United States, 48126
Actively Recruiting
27
Research Site
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
28
Research Site
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
29
Research Site
Traverse City, Michigan, United States, 49684
Withdrawn
30
Research Site
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
31
Research Site
Kansas City, Missouri, United States, 64132
Actively Recruiting
32
Research Site
Bozeman, Montana, United States, 59715
Withdrawn
33
Research Site
Grand Island, Nebraska, United States, 68803
Actively Recruiting
34
Research Site
Omaha, Nebraska, United States, 68130
Actively Recruiting
35
Research Site
Las Vegas, Nevada, United States, 89102
Actively Recruiting
36
Research Site
Reno, Nevada, United States, 89502
Withdrawn
37
Research Site
Voorhees Township, New Jersey, United States, 08043
Suspended
38
Research Site
Stony Brook, New York, United States, 11794
Actively Recruiting
39
Research Site
Greenville, North Carolina, United States, 27834
Actively Recruiting
40
Research Site
Salisbury, North Carolina, United States, 28144
Actively Recruiting
41
Research Site
Cincinnati, Ohio, United States, 45219
Actively Recruiting
42
Research Site
Columbus, Ohio, United States, 43210
Withdrawn
43
Research Site
Maumee, Ohio, United States, 43537
Actively Recruiting
44
Research Site
Toledo, Ohio, United States, 43623
Actively Recruiting
45
Research Site
Portland, Oregon, United States, 97213
Withdrawn
46
Research Site
Greenville, South Carolina, United States, 29607
Actively Recruiting
47
Research Site
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
48
Research Site
Chattanooga, Tennessee, United States, 37404
Withdrawn
49
Research Site
Knoxville, Tennessee, United States, 37920
Withdrawn
50
Research Site
Fort Worth, Texas, United States, 76104
Actively Recruiting
51
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
52
Research Site
Houston, Texas, United States, 77030
Withdrawn
53
Research Site
Houston, Texas, United States, 77090
Suspended
54
Research Site
Kingwood, Texas, United States, 77339
Actively Recruiting
55
Research Site
Odessa, Texas, United States, 79761
Actively Recruiting
56
Research Site
Fort Belvoir, Virginia, United States, 22060
Actively Recruiting
57
Research Site
Leesburg, Virginia, United States, 20176
Actively Recruiting
58
Research Site
Midlothian, Virginia, United States, 23114
Not Yet Recruiting
59
Research Site
Richmond, Virginia, United States, 23230
Actively Recruiting
60
Research Site
Tacoma, Washington, United States, 98405
Actively Recruiting
61
Research Site
Vancouver, Washington, United States, 98684
Actively Recruiting
62
Research Site
Wenatchee, Washington, United States, 98801
Actively Recruiting
63
Research Site
Appleton, Wisconsin, United States, 54911
Actively Recruiting
64
Research Site
Birtinya, Australia, 4575
Actively Recruiting
65
Research Site
Blacktown, Australia, 2148
Actively Recruiting
66
Research Site
Clayton, Australia, 3168
Actively Recruiting
67
Research Site
Gosford, Australia, 2250
Actively Recruiting
68
Research Site
Melbourne, Australia, 3000
Withdrawn
69
Research Site
South Brisbane, Australia, QL 4101
Actively Recruiting
70
Research Site
Wodonga, Australia, 3690
Actively Recruiting
71
Research Site
Innsbruck, Austria, 6020
Actively Recruiting
72
Research Site
Krems, Austria, 3500
Actively Recruiting
73
Research Site
Linz, Austria, 4020
Actively Recruiting
74
Research Site
Rankweil, Austria, 6830
Actively Recruiting
75
Research Site
Vienna, Austria, 1140
Actively Recruiting
76
Research Site
Vienna, Austria, 1210
Actively Recruiting
77
Research Site
Wels, Austria, 4600
Actively Recruiting
78
Research Site
Anderlecht, Belgium, 1070
Withdrawn
79
Research Site
Bruges, Belgium, 8000
Actively Recruiting
80
Research Site
Hasselt, Belgium, 3500
Actively Recruiting
81
Research Site
La Louvière, Belgium, 7100
Actively Recruiting
82
Research Site
Liège, Belgium, 4000
Actively Recruiting
83
Research Site
Barretos, Brazil, 14784-400
Actively Recruiting
84
Research Site
Curitiba, Brazil, 80730-150
Actively Recruiting
85
Research Site
Florianópolis, Brazil, 88034-000
Actively Recruiting
86
Research Site
Ipatinga, Brazil, 35162-189
Actively Recruiting
87
Research Site
Natal, Brazil, 59075-740
Actively Recruiting
88
Research Site
Porto Alegre, Brazil, 91350-200
Actively Recruiting
89
Research Site
Rio de Janeiro, Brazil, 22211-230
Actively Recruiting
90
Research Site
Santa Maria, Brazil, 97015-450
Actively Recruiting
91
Research Site
São Paulo, Brazil, 01221-020
Actively Recruiting
92
Research Site
Taubaté, Brazil, 12030-200
Actively Recruiting
93
Research Site
Vancouver, British Columbia, Canada, VSZ 4E6
Actively Recruiting
94
Research Site
Winnipeg, Manitoba, Canada, R3E 0V9
Withdrawn
95
Research Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naïve locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expression and without actionable genomic alterations.
Thomas Newsom-Davis, Barbara Melosky, Rebecca S Heist...