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
NCT ID: NCT06417814
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
744 participants
INTERVENTIONAL
2024-10-04
2028-09-27
Brief Summary
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Detailed Description
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Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups:
1. Dato-DXd + osimertinib combination therapy
2. Dato-DXd monotherapy
3. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Dato-DXd
Dato-DXd will be administered as IV infusion.
Osimertinib
Osimertinib will be administered orally.
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.
Dato-DXd
Dato-DXd will be administered as IV infusion.
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.
Pemetrexed
Pemetrexed will be administered as IV infusion.
Carboplatin
Carboplatin will be administered as IV infusion.
Cisplatin
Cisplatin will be administered as IV infusion.
Interventions
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Dato-DXd
Dato-DXd will be administered as IV infusion.
Osimertinib
Osimertinib will be administered orally.
Pemetrexed
Pemetrexed will be administered as IV infusion.
Carboplatin
Carboplatin will be administered as IV infusion.
Cisplatin
Cisplatin will be administered as IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
130 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Fayetteville, Arkansas, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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La Jolla, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Athens, Georgia, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Morristown, New Jersey, United States
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Northfield, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Maumee, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Fairfax, Virginia, United States
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Seattle, Washington, United States
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Fitzroy, , Australia
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Heidelberg, , Australia
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Kogarah, , Australia
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Liverpool, , Australia
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Nedlands, , Australia
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Port Macquarie, , Australia
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St Leonards, , Australia
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Westmead, , Australia
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Woodville, , Australia
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Woolloongabba, , Australia
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Charleroi, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Jette, , Belgium
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La Louvière, , Belgium
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Leuven, , Belgium
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Namur, , Belgium
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Roeselare, , Belgium
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Barretos, , Brazil
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Betim, , Brazil
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Blumenau, , Brazil
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Florianópolis, , Brazil
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Pelotas, , Brazil
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Brampton, Ontario, Canada
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Newmarket, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Baoding, , China
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Beijing, , China
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Luzhou, , China
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Nanjing, , China
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Shanghai, , China
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Shantou, , China
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Shenyang, , China
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Tianjin, , China
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Weifang, , China
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Wuhan, , China
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Zhengzhou, , China
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Angers, , France
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Avignon, , France
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Lille, , France
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Pessac, , France
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Quimper, , France
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Toulon Armees, , France
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Toulouse, , France
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Tours, , France
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Villejuif, , France
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Berlin, , Germany
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Berlin-Zehlendorf, , Germany
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Bonn, , Germany
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Essen, , Germany
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Georgsmarienhütte, , Germany
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Giessen, , Germany
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Heidelberg, , Germany
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Kempten, , Germany
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Löwenstein, , Germany
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Nuremberg, , Germany
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Oldenburg, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Thessaloniki, , Greece
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Amravati, , India
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Bhubaneswar, , India
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Hyderabad, , India
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Kolhāpur, , India
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Mumbai, , India
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Mysuru, , India
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Namakkal, , India
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Pune, , India
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Raipur, , India
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Rajasthan, , India
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Ranchi, , India
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Thane, , India
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Trivandrum, , India
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Varanasi, , India
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Beersheba, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Bari, , Italy
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Bunkyō City, , Japan
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Fukuoka, , Japan
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Niigata, , Japan
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Osaka, , Japan
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Sendai, , Japan
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Sunto-gun, , Japan
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Toyoake-shi, , Japan
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Utsunomiya, , Japan
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Wakayama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Alor Star, , Malaysia
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Cheras, , Malaysia
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Johor Bahru, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Kuching, , Malaysia
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Perai, , Malaysia
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Petaling Jaya, , Malaysia
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Amersfoort, , Netherlands
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Harderwijk, , Netherlands
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Rotterdam, , Netherlands
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Zutphen, , Netherlands
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Bacolod, , Philippines
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Cebu City, , Philippines
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Davao City, , Philippines
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Manila, , Philippines
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Quezon, , Philippines
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Quezon, , Philippines
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San Juan City, , Philippines
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Katowice, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Braga, , Portugal
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Lisbon, , Portugal
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Loures, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Craiova, , Romania
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Craiova, , Romania
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Busan, , South Korea
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Chungcheongbuk-do, , South Korea
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Goyang-si, , South Korea
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Gyeonggi-do, , South Korea
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Jinju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, , South Korea
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A Coruña, , Spain
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Barakaldo, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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El Palmar, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Oviedo, , Spain
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Palma de Mallorca, , Spain
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Pamplona, , Spain
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Santander, , Spain
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Santiago de Compostela-Coruña, , Spain
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Seville, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Pathum Thani, , Thailand
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Birmingham, , United Kingdom
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Cambridge, , United Kingdom
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Glasgow, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Middlesbrough, , United Kingdom
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Hanoi, , Vietnam
Countries
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Central Contacts
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References
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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.
Other Identifiers
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2024-511362-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D516KC00001
Identifier Type: -
Identifier Source: org_study_id
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