Non-Small Cell Lung CancerPhase 3TROPION-Lung10NCT06357533

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

A Phase 3 study testing Datopotamab Deruxtecan, Rilvegostomig and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 290 sites in 21 countries.

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Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Datopotamab Deruxtecan, Rilvegostomig and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 675 participants
Where: 290 sitesin 21 countries
Study dates: 11 Apr 2024to 28 Dec 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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

Trial locations and contacts

290 sites in 21 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

290 sites in 21 countries

United States63 sites, 49 recruiting

Research Site
Anaheim, California, 92801
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Anchorage, Alaska, 99508
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Annapolis, Maryland, 21401
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Appleton, Wisconsin, 54911
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Atlanta, Georgia, 30303
Suspended
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Atlanta, Georgia, 30318
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Research Site
Atlanta, Georgia, 30322
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Research Site
Atlanta, Georgia, 30342
Withdrawn
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Beverly Hills, California, 90211
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Boston, Massachusetts, 02114
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Boston, Massachusetts, 02215
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Bozeman, Montana, 59715
Withdrawn
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Chattanooga, Tennessee, 37404
Withdrawn
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Cincinnati, Ohio, 45219
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Clermont, Florida, 34711
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Columbus, Ohio, 43210
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Dearborn, Michigan, 48126
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Farmington Hills, Michigan, 48334
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Fort Belvoir, Virginia, 22060
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Fort Worth, Texas, 76104
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Fountain Valley, California, 92708
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Gainesville, Florida, 32608
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Grand Island, Nebraska, 68803
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Grand Rapids, Michigan, 49503
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Greenville, North Carolina, 27834
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Greenville, South Carolina, 29607
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Hattiesburg, Mississippi, 39401
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Hinsdale, Illinois, 60521
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Research Site
Houston, Texas, 77030
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Research Site
Houston, Texas, 77030
Withdrawn
Research Site
Houston, Texas, 77090
Suspended
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Kansas City, Missouri, 64132
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Kingwood, Texas, 77339
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Knoxville, Tennessee, 37920
Withdrawn
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Las Vegas, Nevada, 89102
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Leesburg, Virginia, 20176
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Little Rock, Arkansas, 72205
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Maumee, Ohio, 43537
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Miami Beach, Florida, 33140
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Midlothian, Virginia, 23114
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Newport Beach, California, 92663
Suspended
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Noblesville, Indiana, 46062
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Odessa, Texas, 79761
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Omaha, Nebraska, 68130
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Orange City, Florida, 32763
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Orlando, Florida, 32806
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Orlando, Florida, 32827
Withdrawn
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Paducah, Kentucky, 42003
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Portland, Oregon, 97213
Withdrawn
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Reno, Nevada, 89502
Withdrawn
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Richmond, Virginia, 23230
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Salisbury, North Carolina, 28144
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Sioux Falls, South Dakota, 57105
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Springdale, Arkansas, 72762
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Stony Brook, New York, 11794
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Tacoma, Washington, 98405
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Toledo, Ohio, 43623
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Traverse City, Michigan, 49684
Withdrawn
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Tucson, Arizona, 85719
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Vancouver, Washington, 98684
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Voorhees Township, New Jersey, 08043
Suspended
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Wenatchee, Washington, 98801
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West Palm Beach, Florida, 33401
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Other trials in United States

China39 sites, 37 recruiting

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Beijing, 100142
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Beijing, 101149
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Changchun, 130000
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Changsha, 410013
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Chengdu, 610000
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Chengdu, 610041
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Chongqing, 400030
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Fuzhou, 350014
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Guangzhou, 510080
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Hangzhou, 310006
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Hangzhou, 310016
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Hangzhou, 310022
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Harbin, 150049
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Hefei, 230031
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Hefei, 230601
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Jinan, 250117
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Jining, 272011
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Kunming, 650118
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Lanzhou, 730000
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Linhai, 317000
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Linyi, 276001
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Nanjing, 210009
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Nanning, 530000
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Nanning, 530021
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Shanghai, 200030
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Shanghai, 200032
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Shanghai, 200433
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Shenyang, 110022
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Taiyuan, 030000
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Tianjin, 300060
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Wenzhou, 325000
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Wuhan, 430000
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Wuhan, 430010
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Wuhan, 430022
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Wuhan, 430030
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Xi'an, 710061
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Yangzhou, 225001
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Zhengzhou, 450000
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Research Site
Zhengzhou, 450008
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Other trials in China

Japan28 sites, 27 recruiting

Research Site
Bunkyō City, 113-8431
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Bunkyō City, 160-0023
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Fukuoka, 812-8582
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Fukuoka, 814-0180
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Hakodate-shi, 040-8611
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Hidaka-shi, 350-1298
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Hirakata-shi, 573-1191
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Hirosaki-shi, 036-8563
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Hiroshima, 730-8518
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Kanazawa, 920-8641
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Kashiwa, 227-8577
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Kawasaki-shi, 216-8511
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Kumamoto, 860-8556
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Matsusaka-shi, 515-8544
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Matsuyama, 790-0024
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Nagoya, 460-0001
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Niigata, 951-8566
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Okayama, 700-8558
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Osaka, 545-8586
Withdrawn
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Osakasayama-shi, 589-8511
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Sagamihara-shi, 252-0375
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Sapporo, 003-0804
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Takaoka-shi, 933-8555
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Takatsuki-shi, 569-8686
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Tokushima, 770-8503
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Tokyo, 104-0045
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Utsunomiya, 320-0834
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Yokohama, 221-0855
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Other trials in Japan

Germany21 sites, 13 recruiting

Research Site
Berlin, 10249
Not yet recruiting
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Bonn, 53113
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Cologne, 50677
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Düsseldorf, 40489
Withdrawn
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Essen, 45136
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Freiburg im Breisgau, 79106
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Gauting, 82131
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Georgsmarienhütte, 49124
Withdrawn
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Gera, 07548
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Gütersloh, 33332
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Hamburg, 20251
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Hamburg, 22087
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Heidelberg, 69126
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Kempten, 87439
Suspended
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Kiel, 24116
Not yet recruiting
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Koblenz, 56068
Suspended
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Ludwigsburg, 71640
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München, 81925
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Nuremberg, 90419
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Potsdam, 14467
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Ravensburg, 88212
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Other trials in Germany

Canada15 sites, 11 recruiting

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Chicoutimi, G7H 5H6
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Lévis, Quebec, G6V 0B8
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London, Ontario, N6A 4L6
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Montreal, Quebec, H3T 1E2
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Montreal, Quebec, H3T 1M5
Withdrawn
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Montreal, Quebec, H4J 1C5
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Newmarket, Ontario, L3Y 2P9
Withdrawn
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Oshawa, Ontario, L1G 2B9
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Rimouski, Quebec, G5L 5T1
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Saskatoon, Saskatchewan, S7N 4H4
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St. John's, Newfoundland and Labrador, A1B 3V6
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Toronto, Ontario, M4N 3M5
Withdrawn
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Trois-Rivières, Quebec, G8Z 3R9
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Vancouver, British Columbia, VSZ 4E6
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Winnipeg, Manitoba, R3E 0V9
Withdrawn

Other trials in Canada

Hungary12 sites, 7 recruiting

Research Site
Budapest, 1121
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Edelény, 3780
Not yet recruiting
Research Site
Gyöngyös, 3200
Withdrawn
Research Site
Gyöngyös - Mátraháza, 3200
Recruiting
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Győr, 9024
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Research Site
Gyula, 5700
Suspended
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Kecskemét, 6000
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Salgótarján, 3100
Withdrawn
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Székesfehérvár, 8000
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Szekszárd, 7100
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Szolnok, 5000
Withdrawn
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Törökbálint, 2045
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Other trials in Hungary

India11 sites, 9 recruiting

Research Site
Chennai, 600031
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Dwārka, 110075
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Jaipur, 302004
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Kolkata, 700099
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Marg Jaipur, 302004
Withdrawn
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Nagpur, 440001
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Nashik, 422011
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New Delhi, 110085
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New Delhi, 11029
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Surat, 395002
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Thiruvananthapuram, 695011
Withdrawn

Other trials in India

Taiwan11 sites, 11 recruiting

Research Site
Changhua, 500
Not yet recruiting
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Kaohsiung City, 80756
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New Taipei City, 220
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Taichung, 40447
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Taichung, 40705
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Tainan, 704
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Taipei, 0116
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Taipei, 10002
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Taipei, 112
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Taipei, TAIWAN
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Taoyuan, 333
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Other trials in Taiwan

Brazil10 sites, 10 recruiting

Research Site
Barretos, 14784-400
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Curitiba, 80730-150
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Florianópolis, 88034-000
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Ipatinga, 35162-189
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Natal, 59075-740
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Porto Alegre, 91350-200
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Rio de Janeiro, 22211-230
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Santa Maria, 97015-450
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São Paulo, 01221-020
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Taubaté, 12030-200
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Other trials in Brazil

Italy10 sites, 10 recruiting

Research Site
Bergamo, 24125
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Genoa, 16132
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Milan, 20141
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Milan, 20162
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Monza, 20052
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Padova, 35128
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Pavia, 27100
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Ravenna, 48100
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Roma, 00128
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Rozzano, 20089
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Other trials in Italy

South Korea9 sites, 9 recruiting

Research Site
Changwon, 51353
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Incheon, 21565
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Seongnam-si, 13496
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Research Site
Seoul, 03080
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Seoul, 03722
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Seoul, 06973
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Research Site
Seoul, 08308
Not yet recruiting
Research Site
Suwon, 16247
Recruiting
Research Site
Suwon, 16499
Recruiting

Other trials in South Korea

United Kingdom8 sites, 5 recruiting

Research Site
Cheltenham, GL53 7AN
Suspended
Research Site
Inverness, IV2 3UJ
Suspended
Research Site
London, SE1 9RT
Withdrawn
Research Site
London, SW10 9NH
Recruiting
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London, SW17 0QT
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Norwich, NR4 7UY
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Preston, PR2 9HT
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Research Site
Truro, TR1 3LJ
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Other trials in United Kingdom

Vietnam8 sites, 5 recruiting

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Da Nang, 550000
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Hà Nội, 100000
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Hanoi, 100000
Recruiting
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Ho Chi Minh City, 700000
Recruiting
Research Site
Ho Chi Minh City, 700000
Withdrawn
Research Site
Huế, 530000
Withdrawn
Research Site
Vinh, 460000
Withdrawn
Research Site
Vĩnh Yên, 280000
Recruiting

Other trials in Vietnam

Australia7 sites, 4 recruiting

Research Site
Birtinya, 4575
Withdrawn
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Blacktown, 2148
Withdrawn
Research Site
Clayton, 3168
Recruiting
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Gosford, 2250
Recruiting
Research Site
Melbourne, 3000
Withdrawn
Research Site
South Brisbane, QL 4101
Recruiting
Research Site
Wodonga, 3690
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Other trials in Australia

Austria7 sites, 6 recruiting

Research Site
Innsbruck, 6020
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Krems, 3500
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Linz, 4020
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Research Site
Rankweil, 6830
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Vienna, 1140
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Vienna, 1210
Recruiting
Research Site
Wels, 4600
Withdrawn

Other trials in Austria

Spain7 sites, 6 recruiting

Research Site
Alicante, 03010
Recruiting
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Barcelona, 08003
Recruiting
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Barcelona, 08036
Recruiting
Research Site
Barcelona, 08041
Not yet recruiting
Research Site
Jerez de la Frontera, 11407
Recruiting
Research Site
Reus, 43204
Recruiting
Research Site
Salamanca, 37007
Withdrawn

Other trials in Spain

Turkey (Türkiye)7 sites, 7 recruiting

Research Site
Adapazarı, 54100
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Research Site
Ankara, 06560
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Research Site
Ankara, 6200
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Antalya, 07070
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Diyarbakır, 21280
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Istanbul, 34030
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Research Site
Istanbul, 34890
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Other trials in Turkey (Türkiye)

Thailand6 sites, 6 recruiting

Research Site
Bangkok, 10400
Recruiting
Research Site
Bangkok, 10700
Recruiting
Research Site
Hat Yai, 90110
Recruiting
Research Site
Muang, 22000
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Research Site
Mueang, 20000
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Research Site
Mueang, 32000
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Other trials in Thailand

Belgium5 sites, 4 recruiting

Research Site
Anderlecht, 1070
Withdrawn
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Bruges, 8000
Recruiting
Research Site
Hasselt, 3500
Recruiting
Research Site
La Louvière, 7100
Recruiting
Research Site
Liège, 4000
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Other trials in Belgium

Poland5 sites, 5 recruiting

Research Site
Olsztyn, 10-357
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Research Site
Poznan, 60-569
Recruiting
Research Site
Przemyśl, 37-700
Recruiting
Research Site
Warsaw, 01-138
Recruiting
Research Site
Warsaw, 02-781
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Other trials in Poland

Puerto Rico1 site, 1 recruiting

Research Site
San Juan, 00909
Recruiting

Other trials in Puerto Rico

About this study

Official title: 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)

Read the 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.

Conditions: Non-Small Cell Lung Cancer
Being tested: Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab
Keywords: NSCLC, Non-Small Cell Lung Cancer, Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab, Non-squamous, PD-L1 expression >=50%, Locally-advanced NSCLC, Metastatic NSCLC
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Datopotamab DeruxtecanDrug
Also called Dato-DXd
Datopotamab Deruxtecan IV (intravenous)
RilvegostomigDrug
Also called AZD2936
Rilvegostomig IV (intravenous)
PembrolizumabDrug
Also called KEYTRUDA
Pembrolizumab IV (intravenous)

Study groups in NCT06357533
Study group	Role	What they receive
Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig	Experimental	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. Receives: Drug: Datopotamab Deruxtecan; Drug: Rilvegostomig
Arm 2: Rilvegostomig Monotherapy	Experimental	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. Receives: Drug: Rilvegostomig
Arm 3: Pembrolizumab Monotherapy	Active comparator	Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS) in TROP2 biomarker positive participants.
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.
Measured: Approximately 4 years
Overall Survival (OS) in TROP2 biomarker positive participants.
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.
Measured: Approximately 6 years

Secondary outcomes (9)

Progression-Free Survival (PFS) in the FAS population.
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.
Measured: Approximately 4 years
Overall Survival (OS) in the FAS population.
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.
Measured: Approximately 6 years
Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations
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.
Measured: Approximately 4 years
Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations
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.
Measured: Approximately 4 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 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.
Measured: Approximately 6 years
Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.
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.
Measured: Approximately 6 years
Pharmacokinetics (PK)
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).
Measured: Approximately 6 years
Immunogenicity
Presence of ADA for Dato-DXd and rilvegostomig (confirmatory results, titres and neutralising antibodies for confirmed positive samples).
Measured: Approximately 6 years
Second Progression-Free Survival (PFS2).
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.
Measured: Approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Apr 202428 Dec 2029

First posted10 Apr 2024
Study start11 Apr 2024
Primary completion28 Dec 2029 (estimated)
Study completion28 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 675 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06357533
Sponsor's protocol ID: D7632C00001
Other IDs: 2023-505077-32-00, 2023
Acronym: TROPION-Lung10
Status last verified: Oct 2026
First submitted: 5 Apr 2024
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

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.
PubMed 41669261

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06357533
Acronym / sponsor ID: TROPION-Lung10 / D7632C00001
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC, Non-Small Cell Lung Cancer, Datopotamab Deruxtecan, Rilvegostomig, Pembrolizumab, Non-squamous, PD-L1 expression >=50%, Locally-advanced NSCLC
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 675 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo
Study start: 11 Apr 2024 (actual)
Primary completion: 28 Dec 2029 (estimated)
Study completion: 28 Dec 2029 (estimated)
First posted: 10 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Parallel Assignment

Arm	Type	Receives
Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig	Experimental	Drug: Datopotamab Deruxtecan, Drug: RilvegostomigParticipants 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.
Arm 2: Rilvegostomig Monotherapy	Experimental	Drug: RilvegostomigParticipants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Arm 3: Pembrolizumab Monotherapy	Active comparator	Drug: PembrolizumabParticipants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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%

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Datopotamab DeruxtecanAlso: Dato-DXdDatopotamab Deruxtecan IV (intravenous)	Drug	Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig
RilvegostomigAlso: AZD2936Rilvegostomig IV (intravenous)	Drug	Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig, Arm 2: Rilvegostomig Monotherapy
PembrolizumabAlso: KEYTRUDAPembrolizumab IV (intravenous)	Drug	Arm 3: Pembrolizumab Monotherapy

Primary outcome

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.
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.

9 secondary outcomes

Progression-Free Survival (PFS) in the FAS population.
Time frame: Approximately 4 years
Overall Survival (OS) in the FAS population.
Time frame: Approximately 6 years
Assessment of Objective Response Rate (ORR) by BICR in TROP2 biomarker positive and FAS populations
Time frame: Approximately 4 years
Assessment of Duration of Response (DoR) by BICR in TROP2 biomarker positive and FAS populations
Time frame: Approximately 4 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
Participant-reported physical functioning in participants treated with Dato DXd in combination with rilvegostomig relative to pembrolizumab.
Time frame: Approximately 6 years
Pharmacokinetics (PK)
Time frame: Approximately 6 years
Immunogenicity
Time frame: Approximately 6 years
Second Progression-Free Survival (PFS2).
Time frame: Approximately 6 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Derived from this study: PubMed 41669261Newsom-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.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Suresh S. Ramalingam, MD principal investigator

Emory University, Atlanta, Georgia, United States of America.

290 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Datopotamab Deruxtecan, Rilvegostomig and Pembrolizumab in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 290 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 290 sites in United States, China, Japan, Germany, Canada and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) in TROP2 biomarker positive participants. (time frame: Approximately 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.