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 (TROPION-Lung10)

May 15, 2026 updated by: AstraZeneca

A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Study Overview

Status

Recruiting

Conditions

Non-Small Cell Lung Cancer

Intervention / Treatment

Detailed Description

This is a Phase III, randomized, open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig monotherapy compared with Pembrolizumab monotherapy for the first-line treatment of participants with locally-advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Study Type

Interventional

Enrollment (Estimated)

675

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Australia
- - Birtinya, Australia, 4575
    - Recruiting
    - Research Site
  - Blacktown, Australia, 2148
    - Recruiting
    - Research Site
  - Clayton, Australia, 3168
    - Recruiting
    - Research Site
  - Gosford, Australia, 2250
    - Recruiting
    - Research Site
  - Melbourne, Australia, 3000
    - Withdrawn
    - Research Site
  - South Brisbane, Australia, QL 4101
    - Recruiting
    - Research Site
  - Wodonga, Australia, 3690
    - Recruiting
    - Research Site
Austria
- - Innsbruck, Austria, 6020
    - Recruiting
    - Research Site
  - Krems, Austria, 3500
    - Recruiting
    - Research Site
  - Linz, Austria, 4020
    - Recruiting
    - Research Site
  - Rankweil, Austria, 6830
    - Recruiting
    - Research Site
  - Vienna, Austria, 1210
    - Recruiting
    - Research Site
  - Vienna, Austria, 1140
    - Recruiting
    - Research Site
  - Wels, Austria, 4600
    - Recruiting
    - Research Site
Belgium
- - Anderlecht, Belgium, 1070
    - Withdrawn
    - Research Site
  - Bruges, Belgium, 8000
    - Recruiting
    - Research Site
  - Hasselt, Belgium, 3500
    - Recruiting
    - Research Site
  - La Louvière, Belgium, 7100
    - Recruiting
    - Research Site
  - Liège, Belgium, 4000
    - Recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Recruiting
    - Research Site
  - Curitiba, Brazil, 80730-150
    - Recruiting
    - Research Site
  - Florianópolis, Brazil, 88034-000
    - Recruiting
    - Research Site
  - Ipatinga, Brazil, 35162-189
    - Recruiting
    - Research Site
  - Natal, Brazil, 59075-740
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-200
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22211-230
    - Recruiting
    - Research Site
  - Santa Maria, Brazil, 97015-450
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01221-020
    - Recruiting
    - Research Site
  - Taubaté, Brazil, 12030-200
    - Recruiting
    - Research Site
Canada
- - Chicoutimi, Canada, G7H 5H6
    - Recruiting
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada, VSZ 4E6
    - Recruiting
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Withdrawn
    - Research Site
- Newfoundland and Labrador
  - St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    - Recruiting
    - Research Site
- Ontario
  - London, Ontario, Canada, N6A 4L6
    - Recruiting
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Withdrawn
    - Research Site
  - Oshawa, Ontario, Canada, L1G 2B9
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Withdrawn
    - Research Site
- Quebec
  - Lévis, Quebec, Canada, G6V 0B8
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3T 1M5
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Research Site
  - Rimouski, Quebec, Canada, G5L 5T1
    - Recruiting
    - Research Site
  - Trois-Rivières, Quebec, Canada, G8Z 3R9
    - Recruiting
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Recruiting
    - Research Site
China
- - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Beijing, China, 101149
    - Recruiting
    - Research Site
  - Changchun, China, 130000
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Chengdu, China, 610000
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Chongqing, China, 400030
    - Recruiting
    - Research Site
  - Fuzhou, China, 350014
    - Recruiting
    - Research Site
  - Guangzhou, China, 510080
    - Recruiting
    - Research Site
  - Hangzhou, China, 310006
    - Recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Recruiting
    - Research Site
  - Hangzhou, China, 310016
    - Recruiting
    - Research Site
  - Harbin, China, 150049
    - Recruiting
    - Research Site
  - Hefei, China, 230601
    - Recruiting
    - Research Site
  - Hefei, China, 230031
    - Withdrawn
    - Research Site
  - Jinan, China, 250117
    - Recruiting
    - Research Site
  - Jining, China, 272011
    - Recruiting
    - Research Site
  - Kunming, China, 650118
    - Recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Linhai, China, 317000
    - Recruiting
    - Research Site
  - Linyi, China, 276001
    - Recruiting
    - Research Site
  - Nanjing, China, 210009
    - Recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Nanning, China, 530000
    - Recruiting
    - Research Site
  - Shanghai, China, 200032
    - Recruiting
    - Research Site
  - Shanghai, China, 200030
    - Recruiting
    - Research Site
  - Shanghai, China, 200433
    - Recruiting
    - Research Site
  - Shenyang, China, 110022
    - Recruiting
    - Research Site
  - Taiyuan, China, 030000
    - Recruiting
    - Research Site
  - Tianjin, China, 300060
    - Recruiting
    - Research Site
  - Wenzhou, China, 325000
    - Recruiting
    - Research Site
  - Wuhan, China, 430022
    - Recruiting
    - Research Site
  - Wuhan, China, 430030
    - Recruiting
    - Research Site
  - Wuhan, China, 430010
    - Recruiting
    - Research Site
  - Wuhan, China, 430000
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Yangzhou, China, 225001
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450000
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
Germany
- - Berlin, Germany, 10249
    - Not yet recruiting
    - Research Site
  - Bonn, Germany, 53113
    - Recruiting
    - Research Site
  - Cologne, Germany, 50677
    - Recruiting
    - Research Site
  - Düsseldorf, Germany, 40489
    - Withdrawn
    - Research Site
  - Essen, Germany, 45136
    - Recruiting
    - Research Site
  - Freiburg im Breisgau, Germany, 79106
    - Recruiting
    - Research Site
  - Gauting, Germany, 82131
    - Recruiting
    - Research Site
  - Georgsmarienhütte, Germany, 49124
    - Recruiting
    - Research Site
  - Gera, Germany, 07548
    - Withdrawn
    - Research Site
  - Gütersloh, Germany, 33332
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20251
    - Recruiting
    - Research Site
  - Hamburg, Germany, 22087
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69126
    - Recruiting
    - Research Site
  - Kempten, Germany, 87439
    - Recruiting
    - Research Site
  - Koblenz, Germany, 56068
    - Suspended
    - Research Site
  - Ludwigsburg, Germany, 71640
    - Withdrawn
    - Research Site
  - München, Germany, 81925
    - Not yet recruiting
    - Research Site
  - Nuremberg, Germany, 90419
    - Recruiting
    - Research Site
  - Potsdam, Germany, 14467
    - Recruiting
    - Research Site
  - Ravensburg, Germany, 88212
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1121
    - Recruiting
    - Research Site
  - Gyula, Hungary, 5700
    - Not yet recruiting
    - Research Site
  - Gyöngyös, Hungary, 3200
    - Withdrawn
    - Research Site
  - Gyöngyös - Mátraháza, Hungary, 3200
    - Recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Recruiting
    - Research Site
  - Kecskemét, Hungary, 6000
    - Recruiting
    - Research Site
  - Salgótarján, Hungary, 3100
    - Recruiting
    - Research Site
  - Szekszárd, Hungary, 7100
    - Recruiting
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Recruiting
    - Research Site
  - Törökbálint, Hungary, 2045
    - Recruiting
    - Research Site
India
- - Chennai, India, 600031
    - Recruiting
    - Research Site
  - Dwārka, India, 110075
    - Recruiting
    - Research Site
  - Jaipur, India, 302004
    - Recruiting
    - Research Site
  - Kolkata, India, 700099
    - Recruiting
    - Research Site
  - Marg Jaipur, India, 302004
    - Withdrawn
    - Research Site
  - Nagpur, India, 440001
    - Recruiting
    - Research Site
  - Nashik, India, 422011
    - Recruiting
    - Research Site
  - New Delhi, India, 11029
    - Recruiting
    - Research Site
  - New Delhi, India, 110085
    - Recruiting
    - Research Site
  - Surat, India, 395002
    - Recruiting
    - Research Site
  - Thiruvananthapuram, India, 695011
    - Recruiting
    - Research Site
Italy
- - Bergamo, Italy, 24125
    - Recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Recruiting
    - Research Site
  - Milan, Italy, 20141
    - Recruiting
    - Research Site
  - Milan, Italy, 20162
    - Recruiting
    - Research Site
  - Monza, Italy, 20052
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Pavia, Italy, 27100
    - Recruiting
    - Research Site
  - Ravenna, Italy, 48100
    - Recruiting
    - Research Site
  - Roma, Italy, 00128
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8431
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 160-0023
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 814-0180
    - Recruiting
    - Research Site
  - Hidaka-shi, Japan, 350-1298
    - Recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Recruiting
    - Research Site
  - Hirosaki-shi, Japan, 036-8563
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 730-8518
    - Recruiting
    - Research Site
  - Kanazawa, Japan, 920-8641
    - Recruiting
    - Research Site
  - Kashiwa, Japan, 227-8577
    - Recruiting
    - Research Site
  - Kawasaki-shi, Japan, 216-8511
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Recruiting
    - Research Site
  - Matsusaka-shi, Japan, 515-8544
    - Not yet recruiting
    - Research Site
  - Nagoya, Japan, 460-0001
    - Recruiting
    - Research Site
  - Niigata, Japan, 951-8566
    - Recruiting
    - Research Site
  - Okayama, Japan, 700-8558
    - Recruiting
    - Research Site
  - Osaka, Japan, 545-8586
    - Recruiting
    - Research Site
  - Osakasayama-shi, Japan, 589-8511
    - Recruiting
    - Research Site
  - Sagamihara-shi, Japan, 252-0375
    - Recruiting
    - Research Site
  - Sapporo, Japan, 003-0804
    - Recruiting
    - Research Site
  - Takaoka-shi, Japan, 933-8555
    - Recruiting
    - Research Site
  - Takatsuki-shi, Japan, 569-8686
    - Recruiting
    - Research Site
  - Tokushima, Japan, 770-8503
    - Recruiting
    - Research Site
  - Tokyo, Japan, 104-0045
    - Recruiting
    - Research Site
  - Utsunomiya, Japan, 320-0834
    - Recruiting
    - Research Site
  - Yokohama, Japan, 221-0855
    - Recruiting
    - Research Site
Poland
- - Olsztyn, Poland, 10-357
    - Recruiting
    - Research Site
  - Poznan, Poland, 60-569
    - Recruiting
    - Research Site
  - Przemyśl, Poland, 37-700
    - Recruiting
    - Research Site
  - Warsaw, Poland, 02-781
    - Recruiting
    - Research Site
  - Warsaw, Poland, 01-138
    - Recruiting
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00909
    - Recruiting
    - Research Site
South Korea
- - Changwon, South Korea, 51353
    - Recruiting
    - Research Site
  - Incheon, South Korea, 21565
    - Recruiting
    - Research Site
  - Seongnam-si, South Korea, 13496
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Suwon, South Korea, 16247
    - Recruiting
    - Research Site
  - Suwon, South Korea, 16499
    - Recruiting
    - Research Site
Spain
- - Alicante, Spain, 03010
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08036
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08003
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08041
    - Not yet recruiting
    - Research Site
  - Jerez de la Frontera, Spain, 11407
    - Recruiting
    - Research Site
  - Reus, Spain, 43204
    - Recruiting
    - Research Site
  - Salamanca, Spain, 37007
    - Withdrawn
    - Research Site
Taiwan
- - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 220
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40447
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Taipei, Taiwan, TAIWAN
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 112
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 0116
    - Recruiting
    - Research Site
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Recruiting
    - Research Site
  - Mueang, Thailand, 20000
    - Recruiting
    - Research Site
  - Mueang, Thailand, 32000
    - Recruiting
    - Research Site
Turkey (Türkiye)
- - Adapazarı, Turkey (Türkiye), 54100
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 6200
    - Recruiting
    - Research Site
  - Ankara, Turkey (Türkiye), 06560
    - Recruiting
    - Research Site
  - Antalya, Turkey (Türkiye), 07070
    - Recruiting
    - Research Site
  - Diyarbakır, Turkey (Türkiye), 21280
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34030
    - Recruiting
    - Research Site
  - Istanbul, Turkey (Türkiye), 34890
    - Recruiting
    - Research Site
United Kingdom
- - Cheltenham, United Kingdom, GL53 7AN
    - Suspended
    - Research Site
  - Inverness, United Kingdom, IV2 3UJ
    - Suspended
    - Research Site
  - London, United Kingdom, SW17 0QT
    - Recruiting
    - Research Site
  - London, United Kingdom, SW10 9NH
    - Recruiting
    - Research Site
  - London, United Kingdom, SE1 9RT
    - Withdrawn
    - Research Site
  - Norwich, United Kingdom, NR4 7UY
    - Not yet recruiting
    - Research Site
  - Preston, United Kingdom, PR2 9HT
    - Recruiting
    - Research Site
  - Truro, United Kingdom, TR1 3LJ
    - Recruiting
    - Research Site
United States
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Recruiting
    - Research Site
- Arizona
  - Tucson, Arizona, United States, 85719
    - Recruiting
    - Research Site
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Recruiting
    - Research Site
  - Springdale, Arkansas, United States, 72762
    - Recruiting
    - Research Site
- California
  - Anaheim, California, United States, 92801
    - Recruiting
    - Research Site
  - Beverly Hills, California, United States, 90211
    - Recruiting
    - Research Site
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Research Site
  - Newport Beach, California, United States, 92663
    - Suspended
    - Research Site
- Florida
  - Clermont, Florida, United States, 34711
    - Recruiting
    - Research Site
  - Gainesville, Florida, United States, 32608
    - Recruiting
    - Research Site
  - Miami Beach, Florida, United States, 33140
    - Recruiting
    - Research Site
  - Orange City, Florida, United States, 32763
    - Recruiting
    - Research Site
  - Orlando, Florida, United States, 32806
    - Recruiting
    - Research Site
  - Orlando, Florida, United States, 32827
    - Withdrawn
    - Research Site
  - West Palm Beach, Florida, United States, 33401
    - Recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30318
    - Recruiting
    - Research Site
  - Atlanta, Georgia, United States, 30342
    - Withdrawn
    - Research Site
  - Atlanta, Georgia, United States, 30303
    - Suspended
    - Research Site
- Illinois
  - Hinsdale, Illinois, United States, 60521
    - Recruiting
    - Research Site
- Indiana
  - Noblesville, Indiana, United States, 46062
    - Recruiting
    - Research Site
- Kentucky
  - Paducah, Kentucky, United States, 42003
    - Not yet recruiting
    - Research Site
- Maryland
  - Annapolis, Maryland, United States, 21401
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Research Site
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Research Site
- Michigan
  - Dearborn, Michigan, United States, 48126
    - Recruiting
    - Research Site
  - Farmington Hills, Michigan, United States, 48334
    - Recruiting
    - Research Site
  - Grand Rapids, Michigan, United States, 49503
    - Recruiting
    - Research Site
  - Traverse City, Michigan, United States, 49684
    - Withdrawn
    - Research Site
- Mississippi
  - Hattiesburg, Mississippi, United States, 39401
    - Recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64132
    - Recruiting
    - Research Site
- Montana
  - Bozeman, Montana, United States, 59715
    - Withdrawn
    - Research Site
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Recruiting
    - Research Site
  - Omaha, Nebraska, United States, 68130
    - Recruiting
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Recruiting
    - Research Site
  - Reno, Nevada, United States, 89502
    - Withdrawn
    - Research Site
- New Jersey
  - Voorhees Township, New Jersey, United States, 08043
    - Suspended
    - Research Site
- New York
  - Stony Brook, New York, United States, 11794
    - Recruiting
    - Research Site
- North Carolina
  - Greenville, North Carolina, United States, 27834
    - Recruiting
    - Research Site
  - Salisbury, North Carolina, United States, 28144
    - Recruiting
    - Research Site
- Ohio
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Withdrawn
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Recruiting
    - Research Site
  - Toledo, Ohio, United States, 43623
    - Recruiting
    - Research Site
- Oregon
  - Portland, Oregon, United States, 97213
    - Withdrawn
    - Research Site
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - Recruiting
    - Research Site
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Recruiting
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Withdrawn
    - Research Site
  - Knoxville, Tennessee, United States, 37920
    - Withdrawn
    - Research Site
- Texas
  - Fort Worth, Texas, United States, 76104
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77030
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77030
    - Withdrawn
    - Research Site
  - Houston, Texas, United States, 77090
    - Suspended
    - Research Site
  - Kingwood, Texas, United States, 77339
    - Recruiting
    - Research Site
  - Odessa, Texas, United States, 79761
    - Recruiting
    - Research Site
- Virginia
  - Fort Belvoir, Virginia, United States, 22060
    - Recruiting
    - Research Site
  - Leesburg, Virginia, United States, 20176
    - Recruiting
    - Research Site
  - Midlothian, Virginia, United States, 23114
    - Not yet recruiting
    - Research Site
  - Richmond, Virginia, United States, 23230
    - Recruiting
    - Research Site
- Washington
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Research Site
  - Vancouver, Washington, United States, 98684
    - Recruiting
    - Research Site
  - Wenatchee, Washington, United States, 98801
    - Recruiting
    - Research Site
- Wisconsin
  - Appleton, Wisconsin, United States, 54911
    - Recruiting
    - Research Site
Vietnam
- - Da Nang, Vietnam, 550000
    - Recruiting
    - Research Site
  - Hanoi, Vietnam, 100000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Research Site
  - Ho Chi Minh City, Vietnam, 700000
    - Withdrawn
    - Research Site
  - Huế, Vietnam, 530000
    - Withdrawn
    - Research Site
  - Hà Nội, Vietnam, 100000
    - Recruiting
    - Research Site
  - Vinh, Vietnam, 460000
    - Withdrawn
    - Research Site
  - Vĩnh Yên, Vietnam, 280000
    - Recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histologically or cytologically documented non-squamous NSCLC.
Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies.
Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
Known tumour PD-L1 expression status defined as TC ≥ 50%
At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
ECOG performance status of 0 or 1
Adequate bone marrow reserve and organ function

Exclusion Criteria:

Prior systemic therapy for advanced/metastatic NSCLC.
Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
History of another primary malignancy within 3 years
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol.
Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Has significant pulmonary function compromise, as determined by the investigator
Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
History of leptomeningeal carcinomatosis
Known clinically significant corneal disease
Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
History of active primary immunodeficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 2: Rilvegostomig Monotherapy Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.	Drug: Rilvegostomig Rilvegostomig IV (intravenous) Other Names: AZD2936
Active Comparator: Arm 3: Pembrolizumab Monotherapy Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.	Drug: Pembrolizumab Pembrolizumab IV (intravenous) Other Names: KEYTRUDA
Experimental: Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.	Drug: Datopotamab Deruxtecan Datopotamab Deruxtecan IV (intravenous) Other Names: Dato-DXd Drug: Rilvegostomig Rilvegostomig IV (intravenous) Other Names: AZD2936

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) in TROP2 biomarker positive participants. Time Frame: Approximately 4 years	PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.	Approximately 4 years
Overall Survival (OS) in TROP2 biomarker positive participants. Time Frame: Approximately 6 years	OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • TROP2 biomarker positive population The measure of interest is the HR of OS.	Approximately 6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK) Time Frame: Approximately 6 years	Concentration of rilvegostomig, Dato-DXd, total anti TROP2 antibody, and MAAA 1181a (payload deruxtecan) in plasma or serum and PK parameters (peak and trough concentrations).	Approximately 6 years
Immunogenicity Time Frame: Approximately 6 years	Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).	Approximately 6 years
Progression-Free Survival (PFS) in the FAS population. Time Frame: Approximately 4 years	PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following population: • FAS population The measure of interest is the HR of PFS. PFS by investigator will be reported as a sensitivity analysis.	Approximately 4 years
Overall Survival (OS) in the FAS population. Time Frame: Approximately 6 years	OS is defined as the time from randomisation until the date of death due to any cause. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy, in the following population: • FAS population The measure of interest is the HR of OS.	Approximately 6 years
Participant-reported lung cancer symptoms of NSCLC and participant-reported GHS/QOL in participants treated with Dato-DXd in combination with rilvegostomig relative to pembrolizumab. Time Frame: Approximately 6 years	Time to deterioration in: pulmonary symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ, in overall lung cancer symptoms as measured by the NSCLC-SAQ, and in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172. Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations: TROP2 biomarker positive population FAS population The measure of interest is the HR of time to deterioration in pulmonary symptoms, HR of time to deterioration in overall lung cancer symptoms, and HR of time to deterioration in GHS/QoL.	Approximately 6 years
Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab. Time Frame: Approximately 6 years	Time to deterioration in physical functioning as measured by PROMIS Physical Function short form 8c. Time to deterioration is defined as the time from randomisation until the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analyses will include all randomised participants, in the following populations: TROP2 biomarker positive population FAS population The measure of interest is the HR of time to deterioration in physical functioning.	Approximately 6 years
Second Progression-Free Survival (PFS2). Time Frame: Approximately 6 years	PFS2 is defined as the time from randomisation to the earliest of the progression events (following the initial progression), subsequent to first subsequent therapy, or death. Progression event includes radiological (RECIST 1.1) or clinical disease progression. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard practice. The analyses will include all randomised participants, as randomised, regardless of whether the participant withdraws from subsequent therapy and regardless of missed visits, in the following populations: TROP2 biomarker positive population FAS population The measure of interest is the HR of PFS2.	Approximately 6 years
Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations Time Frame: Approximately 4 years	ORR is defined as the proportion of participants who have a CR or PR, as determined by BICR per RECIST 1.1. The analyses will include all randomised participants, as randomised, with measurable disease at baseline, in the following populations: TROP2 biomarker positive population FAS population Data obtained from randomisation up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR, regardless of whether the participant withdraws from therapy. Participants who go off treatment without a response or progression, receive a subsequent therapy, and then respond will not be included as responders in the ORR. The measure of interest is the difference of the ORR. ORR by investigator will be reported as a sensitivity analysis.	Approximately 4 years
Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations Time Frame: Approximately 4 years	DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1, as assessed by BICR or death due to any cause. The analyses will include all randomised participants who have a response, as randomised, regardless of whether the participant withdraws from randomised therapy, receives another anti cancer therapy or clinically progresses prior to RECIST 1.1 progression, in the following populations: TROP2 biomarker positive population FAS population The measure of interest is the median of DoR. DoR by investigator will be reported as a sensitivity analysis.	Approximately 4 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Dato-DXd in combination with rilvegostomig and rilvegostomig monotherapy as compared with pembrolizumab. Time Frame: Approximately 6 years	Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE Version 5.0).	Approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo

Investigators

Principal Investigator: Suresh S. Ramalingam, MD, Emory University, Atlanta, Georgia, United States of America.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Newsom-Davis T, Melosky B, Heist RS, Lu S, Pasello G, Chen X, Stachowiak M, Lyfar P, Forcina A, Ramalingam SS. TROPION-Lung10: a phase 3 study of datopotamab deruxtecan and rilvegostomig in patients with treatment-naive locally advanced or metastatic nonsquamous non-small cell lung cancer with high PD-L1 expression and without actionable genomic alterations. Front Oncol. 2026 Jan 26;15:1721624. doi: 10.3389/fonc.2025.1721624. eCollection 2025.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Estimated)

December 28, 2029

Study Completion (Estimated)

December 28, 2029

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D7632C00001
2023-505077-32-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.

For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool .

Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on Datopotamab Deruxtecan

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