A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung15)

May 13, 2026 updated by: AstraZeneca

A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

Study Overview

Status

Recruiting

Conditions

Metastatic Non-small Cell Lung Cancer

Intervention / Treatment

Detailed Description

This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in participants with epidermal growth factor receptor gene mutation (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on prior osimertinib treatment.

Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups:

Dato-DXd + osimertinib combination therapy
Dato-DXd monotherapy
Platinum-based doublet chemotherapy

Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator, unacceptable toxicity, or other discontinuation criterion is met.

After study intervention discontinuation, all participants will undergo an end of treatment (EoT) visit within 35 days of discontinuation and will be followed up for safety assessments 28 (+ 7) days after their last dose of study intervention.

Study Type

Interventional

Enrollment (Estimated)

744

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
- - Fitzroy, Australia, VIC3065
    - Recruiting
    - Research Site
  - Heidelberg, Australia, 3084
    - Recruiting
    - Research Site
  - Kogarah, Australia, 2217
    - Recruiting
    - Research Site
  - Liverpool, Australia, 2170
    - Recruiting
    - Research Site
  - Nedlands, Australia, 6009
    - Recruiting
    - Research Site
  - Port Macquarie, Australia, 2444
    - Recruiting
    - Research Site
  - St Leonards, Australia, 2065
    - Recruiting
    - Research Site
  - Westmead, Australia, 2145
    - Recruiting
    - Research Site
  - Woodville, Australia, 5011
    - Withdrawn
    - Research Site
  - Woolloongabba, Australia, 4102
    - Recruiting
    - Research Site
Belgium
- - Charleroi, Belgium, 6060
    - Recruiting
    - Research Site
  - Edegem, Belgium, 2650
    - Recruiting
    - Research Site
  - Ghent, Belgium, 9000
    - Recruiting
    - Research Site
  - Hasselt, Belgium, 3500
    - Recruiting
    - Research Site
  - Jette, Belgium, 1090
    - Recruiting
    - Research Site
  - La Louvière, Belgium, 7100
    - Recruiting
    - Research Site
  - Leuven, Belgium, 3000
    - Recruiting
    - Research Site
  - Namur, Belgium, 5000
    - Recruiting
    - Research Site
  - Roeselare, Belgium, 8800
    - Recruiting
    - Research Site
Brazil
- - Barretos, Brazil, 14784-400
    - Recruiting
    - Research Site
  - Betim, Brazil, 32671-550
    - Recruiting
    - Research Site
  - Blumenau, Brazil, 89010-340
    - Recruiting
    - Research Site
  - Florianópolis, Brazil, 88040-970
    - Recruiting
    - Research Site
  - Itajaí, Brazil, 88301-220
    - Recruiting
    - Research Site
  - Pelotas, Brazil, 96020-080
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90610-000
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-074
    - Recruiting
    - Research Site
  - Porto Alegre, Brazil, 90470-340
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22281-100
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22250-905
    - Recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22775-001
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01327-001
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 01323-900
    - Withdrawn
    - Research Site
Canada
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - Recruiting
    - Research Site
  - Newmarket, Ontario, Canada, L3Y 2P9
    - Withdrawn
    - Research Site
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 1Z5
    - Recruiting
    - Research Site
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - Research Site
  - Québec, Quebec, Canada, G1R 2J6
    - Recruiting
    - Research Site
China
- - Baoding, China, 071000
    - Recruiting
    - Research Site
  - Beijing, China, 100730
    - Recruiting
    - Research Site
  - Beijing, China, 100034
    - Recruiting
    - Research Site
  - Beijing, China, 100044
    - Recruiting
    - Research Site
  - Beijing, China, 100050
    - Recruiting
    - Research Site
  - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Beijing, China, 100005
    - Recruiting
    - Research Site
  - Beijing, China, 101199
    - Recruiting
    - Research Site
  - Bengbu, China, 233004
    - Recruiting
    - Research Site
  - Changchun, China, 130021
    - Recruiting
    - Research Site
  - Changchun, China, 130012
    - Recruiting
    - Research Site
  - Changsha, China, 410013
    - Recruiting
    - Research Site
  - Chengdu, China, 610041
    - Recruiting
    - Research Site
  - Deyang, China, 618000
    - Recruiting
    - Research Site
  - Ganzhou, China, 341099
    - Recruiting
    - Research Site
  - Guangzhou, China, 510180
    - Recruiting
    - Research Site
  - Hangzhou, China, 310003
    - Recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Recruiting
    - Research Site
  - Hefei, China, 230001
    - Recruiting
    - Research Site
  - Hengyang, China, 421001
    - Recruiting
    - Research Site
  - Huaian, China, 223399
    - Recruiting
    - Research Site
  - Jinan, China, 250013
    - Recruiting
    - Research Site
  - Linyi, China, 276000
    - Recruiting
    - Research Site
  - Luoyang, China, 471003
    - Recruiting
    - Research Site
  - Luzhou, China, 646000
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanjing, China, 210009
    - Recruiting
    - Research Site
  - Shanghai, China, 200433
    - Recruiting
    - Research Site
  - Shantou, China
    - Recruiting
    - Research Site
  - Shenyang, China, 110042
    - Recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Tianjin, China, 300201
    - Recruiting
    - Research Site
  - Tianjin, China, CN-300052
    - Recruiting
    - Research Site
  - Weifang, China, 261000
    - Recruiting
    - Research Site
  - Wuhan, China, 430060
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450000
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450001
    - Recruiting
    - Research Site
France
- - Angers, France, 49933
    - Recruiting
    - Research Site
  - Avignon, France, 84902
    - Recruiting
    - Research Site
  - Bordeaux, France, 33076
    - Recruiting
    - Research Site
  - Caen, France, 14000
    - Recruiting
    - Research Site
  - Lille, France, 59037
    - Recruiting
    - Research Site
  - Montpellier, France, 34298
    - Recruiting
    - Research Site
  - Nantes, France, 44093
    - Recruiting
    - Research Site
  - Paris, France, 75014
    - Recruiting
    - Research Site
  - Paris, France, 75970
    - Recruiting
    - Research Site
  - Pessac, France, 33604
    - Recruiting
    - Research Site
  - Quimper, France, 29000
    - Withdrawn
    - Research Site
  - Toulon Armees, France, 83800
    - Recruiting
    - Research Site
  - Toulouse, France, 31400
    - Recruiting
    - Research Site
  - Tours, France, 37000
    - Recruiting
    - Research Site
  - Villejuif, France, 94805
    - Recruiting
    - Research Site
Germany
- - Berlin, Germany, 12351
    - Recruiting
    - Research Site
  - Berlin-Zehlendorf, Germany, 14165
    - Recruiting
    - Research Site
  - Bonn, Germany, 53127
    - Withdrawn
    - Research Site
  - Essen, Germany, 45122
    - Recruiting
    - Research Site
  - Georgsmarienhütte, Germany, 49124
    - Recruiting
    - Research Site
  - Giessen, Germany, 35392
    - Recruiting
    - Research Site
  - Großhansdorf, Germany, 22927
    - Recruiting
    - Research Site
  - Hamburg, Germany, 20251
    - Recruiting
    - Research Site
  - Hamburg, Germany, 21075
    - Recruiting
    - Research Site
  - Heidelberg, Germany, 69126
    - Withdrawn
    - Research Site
  - Kempten, Germany, 87439
    - Withdrawn
    - Research Site
  - Löwenstein, Germany, 74245
    - Recruiting
    - Research Site
  - Nuremberg, Germany, 90419
    - Recruiting
    - Research Site
  - Oldenburg, Germany, 26121
    - Recruiting
    - Research Site
Greece
- - Athens, Greece, 11527
    - Recruiting
    - Research Site
  - Athens, Greece, 12462
    - Withdrawn
    - Research Site
  - Athens, Greece, 11526
    - Recruiting
    - Research Site
  - Athens, Greece, 18547
    - Recruiting
    - Research Site
  - Heraklion, Greece, 71110
    - Withdrawn
    - Research Site
  - Thessaloniki, Greece, 57010
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 57001
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 552 36
    - Recruiting
    - Research Site
  - Thessaloniki, Greece, 56249
    - Withdrawn
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - Research Site
  - Hong Kong, Hong Kong
    - Withdrawn
    - Research Site
  - Hong Kong, Hong Kong, 999077
    - Recruiting
    - Research Site
  - Hong Kong, Hong Kong, 999077
    - Withdrawn
    - Research Site
  - Shatin, Hong Kong, 00000
    - Recruiting
    - Research Site
India
- - Amravati, India, 444606
    - Recruiting
    - Research Site
  - Bhubaneswar, India, 751019
    - Recruiting
    - Research Site
  - Hyderabad, India, 500034
    - Recruiting
    - Research Site
  - Kolhāpur, India, 416234
    - Recruiting
    - Research Site
  - Mumbai, India, 400012
    - Not yet recruiting
    - Research Site
  - Mysuru, India, 570017
    - Recruiting
    - Research Site
  - Namakkal, India, 637001
    - Recruiting
    - Research Site
  - Pune, India, 411001
    - Recruiting
    - Research Site
  - Raipur, India, 492001
    - Recruiting
    - Research Site
  - Rajasthan, India, 313001
    - Recruiting
    - Research Site
  - Ranchi, India, 834001
    - Recruiting
    - Research Site
  - Thane, India, 401107
    - Recruiting
    - Research Site
  - Trivandrum, India, 695011
    - Recruiting
    - Research Site
  - Varanasi, India, 221005
    - Recruiting
    - Research Site
Israel
- - Beersheba, Israel, 8410101
    - Recruiting
    - Research Site
  - Haifa, Israel, 3109601
    - Recruiting
    - Research Site
  - Haifa, Israel, 34362
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91031
    - Recruiting
    - Research Site
  - Jerusalem, Israel, 91120
    - Recruiting
    - Research Site
  - Kfar Saba, Israel, 4428164
    - Recruiting
    - Research Site
  - Petah Tikva, Israel, 49100
    - Recruiting
    - Research Site
  - Ramat Gan, Israel, 52621
    - Recruiting
    - Research Site
  - Tel Aviv, Israel, 62748
    - Recruiting
    - Research Site
Italy
- - Bari, Italy, 70124
    - Recruiting
    - Research Site
  - Milan, Italy, 20141
    - Recruiting
    - Research Site
  - Misterbianco, Italy, 95045
    - Recruiting
    - Research Site
  - Monza, Italy, 20090
    - Recruiting
    - Research Site
  - Naples, Italy, 80131
    - Recruiting
    - Research Site
  - Orbassano, Italy, 10043
    - Recruiting
    - Research Site
  - Padova, Italy, 35128
    - Recruiting
    - Research Site
  - Parma, Italy, 43126
    - Withdrawn
    - Research Site
  - Perugia, Italy, 06100
    - Recruiting
    - Research Site
  - Roma, Italy, 00144
    - Recruiting
    - Research Site
  - Rozzano, Italy, 20089
    - Recruiting
    - Research Site
  - Verona, Italy, 37126
    - Recruiting
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8431
    - Recruiting
    - Research Site
  - Bunkyō City, Japan, 113-8603
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Hiroshima, Japan, 734-8551
    - Recruiting
    - Research Site
  - Iruma-Gun, Japan, 350-0495
    - Recruiting
    - Research Site
  - Iwakuni-shi, Japan, 740-8510
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0046
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Recruiting
    - Research Site
  - Kyoto, Japan, 602-8566
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Matsuyama, Japan, 791-0280
    - Recruiting
    - Research Site
  - Nagoya, Japan, 466-8560
    - Recruiting
    - Research Site
  - Nagoya, Japan, 464-8681
    - Withdrawn
    - Research Site
  - Niigata, Japan, 951-8566
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Osaka, Japan, 534-0021
    - Recruiting
    - Research Site
  - Sendai, Japan, 981-0914
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Recruiting
    - Research Site
  - Utsunomiya, Japan, 320-0834
    - Recruiting
    - Research Site
  - Wakayama, Japan, 641-8510
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
  - Yokohama, Japan, 236-0051
    - Recruiting
    - Research Site
  - Ōsaka-sayama, Japan, 589-8511
    - Recruiting
    - Research Site
Malaysia
- - Alor Star, Malaysia, 05460
    - Recruiting
    - Research Site
  - Cheras, Malaysia, 56000
    - Recruiting
    - Research Site
  - Johor Bahru, Malaysia, 81100
    - Recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Research Site
  - Kuala Selangor, Malaysia, 46050
    - Recruiting
    - Research Site
  - Kuching, Malaysia, 93586
    - Recruiting
    - Research Site
  - Perai, Malaysia, 13700
    - Recruiting
    - Research Site
  - Petaling Jaya, Malaysia, 47500
    - Recruiting
    - Research Site
Netherlands
- - Amersfoort, Netherlands, 3813 TZ
    - Withdrawn
    - Research Site
  - Amsterdam, Netherlands, 1066CX
    - Withdrawn
    - Research Site
  - Harderwijk, Netherlands, 3844 DG
    - Withdrawn
    - Research Site
  - Rotterdam, Netherlands, 3015 GD
    - Withdrawn
    - Research Site
  - Zutphen, Netherlands, 7207 AE
    - Withdrawn
    - Research Site
Philippines
- - Bacolod, Philippines, 6100
    - Recruiting
    - Research Site
  - Cebu City, Philippines, 6000
    - Recruiting
    - Research Site
  - Davao City, Philippines, 8000
    - Recruiting
    - Research Site
  - Manila, Philippines, 1000
    - Recruiting
    - Research Site
  - Quezon, Philippines, 1102
    - Recruiting
    - Research Site
  - Quezon, Philippines, 1104
    - Recruiting
    - Research Site
  - San Juan City, Philippines, 1500
    - Recruiting
    - Research Site
Poland
- - Katowice, Poland, 40-519
    - Recruiting
    - Research Site
  - Krakow, Poland, 30-727
    - Recruiting
    - Research Site
  - Lodz, Poland, 90-302
    - Recruiting
    - Research Site
  - Olsztyn, Poland, 10-357
    - Recruiting
    - Research Site
  - Poznan, Poland, 60-569
    - Recruiting
    - Research Site
Portugal
- - Braga, Portugal, 4710
    - Withdrawn
    - Research Site
  - Lisbon, Portugal, 1500-650
    - Withdrawn
    - Research Site
  - Loures, Portugal, 2674-514
    - Withdrawn
    - Research Site
  - Porto, Portugal, 4099-001
    - Withdrawn
    - Research Site
  - Porto, Portugal, 4200-072
    - Withdrawn
    - Research Site
Romania
- - Craiova, Romania, 200385
    - Withdrawn
    - Research Site
  - Craiova, Romania, 200542
    - Withdrawn
    - Research Site
Singapore
- - Singapore, Singapore, 308433
    - Recruiting
    - Research Site
  - Singapore, Singapore, 217562
    - Recruiting
    - Research Site
  - Singapore, Singapore, 168583
    - Recruiting
    - Research Site
South Korea
- - Busan, South Korea, 48108
    - Recruiting
    - Research Site
  - Chungcheongbuk-do, South Korea, 28644
    - Recruiting
    - Research Site
  - Goyang-si, South Korea, 10408
    - Recruiting
    - Research Site
  - Gyeonggi-do, South Korea, 13620
    - Recruiting
    - Research Site
  - Jinju, South Korea, 52727
    - Withdrawn
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 5505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
  - Suwon, South Korea, 16247
    - Recruiting
    - Research Site
Spain
- - A Coruña, Spain, 15009
    - Recruiting
    - Research Site
  - Barakaldo, Spain, 48903
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08041
    - Recruiting
    - Research Site
  - Barcelona, Spain, 08003
    - Recruiting
    - Research Site
  - El Palmar, Spain, 30120
    - Recruiting
    - Research Site
  - L'Hospitalet de Llobregat, Spain, 08908
    - Recruiting
    - Research Site
  - Madrid, Spain, 28027
    - Recruiting
    - Research Site
  - Madrid, Spain, 28046
    - Recruiting
    - Research Site
  - Majadahonda, Spain, 28222
    - Recruiting
    - Research Site
  - Málaga, Spain, 29004
    - Recruiting
    - Research Site
  - Oviedo, Spain, 33006
    - Recruiting
    - Research Site
  - Palma de Mallorca, Spain, 7120
    - Recruiting
    - Research Site
  - Pamplona, Spain, 31008
    - Recruiting
    - Research Site
  - Santander, Spain, 39008
    - Recruiting
    - Research Site
  - Santiago de Compostela-Coruña, Spain, 15706
    - Recruiting
    - Research Site
  - Seville, Spain, 41014
    - Recruiting
    - Research Site
  - Valencia, Spain, 46010
    - Recruiting
    - Research Site
  - Valencia, Spain, 46026
    - Recruiting
    - Research Site
  - Valladolid, Spain, 47003
    - Recruiting
    - Research Site
Taiwan
- - Changhua, Taiwan, 50006
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - New Taipei City, Taiwan, 23561
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Recruiting
    - Research Site
  - Taichung, Taiwan, 404
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 70403
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 73657
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 100
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 112
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 110
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
  - Pathum Thani, Thailand, 12120
    - Recruiting
    - Research Site
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Recruiting
    - Research Site
  - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Research Site
  - Glasgow, United Kingdom, G12 0YN
    - Recruiting
    - Research Site
  - Leicester, United Kingdom, LE1 5WW
    - Recruiting
    - Research Site
  - London, United Kingdom, EC1A 7BE
    - Recruiting
    - Research Site
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - Research Site
  - Middlesbrough, United Kingdom, TS4 3BW
    - Recruiting
    - Research Site
United States
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Recruiting
    - Research Site
- California
  - Duarte, California, United States, 91010
    - Withdrawn
    - Research Site
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Research Site
  - La Jolla, California, United States, 92093
    - Recruiting
    - Research Site
  - Los Angeles, California, United States, 90048
    - Withdrawn
    - Research Site
  - San Diego, California, United States, 92123
    - Recruiting
    - Research Site
- Colorado
  - Colorado Springs, Colorado, United States, 80909
    - Recruiting
    - Research Site
  - Fort Collins, Colorado, United States, 80528
    - Recruiting
    - Research Site
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Not yet recruiting
    - Research Site
- Florida
  - Gainesville, Florida, United States, 32608
    - Withdrawn
    - Research Site
  - Jacksonville, Florida, United States, 32256
    - Recruiting
    - Research Site
- Georgia
  - Athens, Georgia, United States, 30607
    - Recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Research Site
  - Evanston, Illinois, United States, 60201
    - Recruiting
    - Research Site
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Recruiting
    - Research Site
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Research Site
  - Boston, Massachusetts, United States, 02114
    - Withdrawn
    - Research Site
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64132
    - Recruiting
    - Research Site
- Nebraska
  - Omaha, Nebraska, United States, 68124
    - Recruiting
    - Research Site
- New Jersey
  - Morristown, New Jersey, United States, 07960
    - Recruiting
    - Research Site
  - Northfield, New Jersey, United States, 08225
    - Recruiting
    - Research Site
- New York
  - New York, New York, United States, 10065
    - Recruiting
    - Research Site
  - New York, New York, United States, 10016
    - Withdrawn
    - Research Site
  - The Bronx, New York, United States, 10461
    - Recruiting
    - Research Site
- Ohio
  - Maumee, Ohio, United States, 43537
    - Recruiting
    - Research Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Withdrawn
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15232
    - Recruiting
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Research Site
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Research Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Research Site
- Washington
  - Seattle, Washington, United States, 98104
    - Withdrawn
    - Research Site
Vietnam
- - Hanoi, Vietnam, 100000
    - 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 confirmed non-squamous NSCLC.
Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in combination with other EGFR mutations, which may include T790M).
Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
Less than or equal to (<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate bone marrow reserve and organ function within 7 days before randomization.

Exclusion Criteria:

Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
Has significant third-space fluid retention (example [eg.], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
Unstable spinal cord compression and/or unstable brain metastases.
Participants with symptomatic brain metastases (including leptomeningeal involvement).
Clinically significant corneal disease.
Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization.
Has known human immunodeficiency virus (HIV) infection that is not well controlled.

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: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 3: Platinum-based Doublet Chemotherapy Participants will receive pemetrexed 500 milligrams per meter square (mg/m2) in combination with carboplatin (AUC5) or cisplatin 75 mg/m2 as IV infusion Q3W for 4 cycles followed by pemetrexed maintenance 500 mg/m2 as IV infusion Q3W, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or another discontinuation criterion is met.	Drug: Carboplatin Carboplatin will be administered as IV infusion. Drug: Pemetrexed Pemetrexed will be administered as IV infusion. Drug: Cisplatin Cisplatin will be administered as IV infusion.
Experimental: Group 1: Dato-DXd + Osimertinib Combination Therapy Participants will receive Dato-DXd 6 milligrams per kilogram (mg/kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21-day cycle, and osimertinib 80 milligrams (mg) once daily (QD) orally, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.	Drug: Osimertinib Osimertinib will be administered orally. Other Names: AZD9291 Tagrisso Drug: Dato-DXd Dato-DXd will be administered as IV infusion. Other Names: DS-1062a
Experimental: Group 2: Dato-DXd Monotherapy Participants will receive Dato-DXd 6 mg/kg as IV infusion Q3W on Day 1 of every 21-day cycle, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.	Drug: Dato-DXd Dato-DXd will be administered as IV infusion. Other Names: DS-1062a

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free Survival (PFS) Time Frame: Up to 2.5 years	PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression.	Up to 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to 3.5 years	OS is defined as time from randomization until the date of death due to any cause.	Up to 3.5 years
Central Nervous System Progression-free Survival (CNS PFS) Time Frame: Up to 2.5 years	CNS PFS is defined as the time from randomization to BICR confirmed progression in the CNS or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinically progresses prior to BICR confirmed CNS modified RECIST v1.1 progression.	Up to 2.5 years
Objective Response Rate (ORR) Time Frame: Up to 2.5 years	ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by BICR per RECIST v1.1.	Up to 2.5 years
Duration of Response (DoR) Time Frame: Up to 2.5 years	DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, as assessed by BICR or death due to any cause.	Up to 2.5 years
Progression-free Survival-2 (PFS-2) Time Frame: Up to 3.5 years	PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial investigator assessed progression), after first subsequent therapy, or death.	Up to 3.5 years
Objective Response Rate (ORR) Using CNS Modified RECIST v1.1 Time Frame: Up to 2.5 years	ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, using CNS modified RECIST v1.1.	Up to 2.5 years
Duration of Response (DoR) Using CNS Modified RECIST v1.1 Time Frame: Up to 2.5 years	DoR is defined as the time from the date of first documented response until date of documented progression or death due to any cause using CNS modified RECIST v1.1.	Up to 2.5 years
Time to Deterioration in Pulmonary Symptoms Time Frame: Up to 3.5 years	Time to deterioration (in pulmonary symptoms [dyspnea, cough, and chest pain]) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.	Up to 3.5 years
Time to Deterioration in Physical Functioning Time Frame: Up to 3.5 years	Time to deterioration in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 8c will be evaluated. Time to deterioration (in physical functionating) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.	Up to 3.5 years
Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) Time Frame: Up to 3.5 years	Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172 will be reported. Time to deterioration (in GHS/QoL) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.	Up to 3.5 years
Pharmacokinetics (PK) of Dato-DXd Time Frame: Up to 3.5 years	Concentration of Dato-DXd, total anti-TROP2 antibody and DXd in plasma.	Up to 3.5 years
Immunogenicity of Dato-DXd Time Frame: Up to 3.5 years	Presence of antidrug antibody (ADAs) for Dato-DXd (confirmatory results: positive or negative, titers).	Up to 3.5 years

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Daiichi Sankyo

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

Tan DS, Nadal E, Cheema P, Wu YL, Ahn MJ, Tanizaki J, Grainger E, Nizialek E, Forcina A, van der Gronde T, Yu HA. TROPION-Lung15: a randomized phase III study of osimertinib combined with datopotamab deruxtecan (Dato-DXd) or Dato-DXd alone versus platinum-doublet chemotherapy in patients with EGFR-mutated advanced non-small cell lung cancer and whose disease has progressed on prior osimertinib. Ther Adv Med Oncol. 2025 Dec 23;17:17588359251385410. doi: 10.1177/17588359251385410. 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)

October 4, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 27, 2028

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

D516KC00001
2024-511362-37-00 (Registry Identifier: CTIS)

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.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage 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

Collaborators and Investigators

Sponsor

Collaborators

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

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