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)
Status: Recruiting
Location: See all (283) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 without actionable genomic alterations.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alaska
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Anchorage
Arkansas
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Little Rock
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Springdale
Arizona
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Tucson
California
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Anaheim
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Beverly Hills
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Fountain Valley
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Newport Beach
Florida
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Clermont
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Gainesville
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Miami Beach
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Orange City
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Orlando
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Orlando
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West Palm Beach
Georgia
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Atlanta
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Atlanta
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Atlanta
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Atlanta
Illinois
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Hinsdale
Indiana
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Noblesville
Kentucky
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Paducah
Massachusetts
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Boston
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Boston
Maryland
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Annapolis
Michigan
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Dearborn
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Farmington Hills
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Grand Rapids
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Traverse City
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Kansas City
Mississippi
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Hattiesburg
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Bozeman
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Greenville
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Salisbury
Nebraska
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Grand Island
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Omaha
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Voorhees Township
Nevada
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Las Vegas
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Reno
New York
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Stony Brook
Ohio
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Cincinnati
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Columbus
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Maumee
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Toledo
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Portland
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Greenville
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Sioux Falls
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Chattanooga
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Knoxville
Texas
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Fort Worth
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Houston
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Houston
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Houston
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Kingwood
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Odessa
Virginia
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Fort Belvoir
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Leesburg
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Midlothian
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Richmond
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Tacoma
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Wenatchee
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Australia
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Birtinya
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Blacktown
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Clayton
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Gosford
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South Brisbane
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Wodonga
Austria
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Innsbruck
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Krems
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Linz
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Rankweil
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Vienna
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Vienna
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Wels
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Bruges
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Liège
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Natal
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Porto Alegre
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Rio De Janeiro
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Santa Maria
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São Paulo
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Taubaté
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Chicoutimi
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Lévis
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London
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Montreal
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Montreal
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Montreal
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Newmarket
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Oshawa
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Rimouski
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Saskatoon
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St. John's
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Toronto
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Trois-rivières
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Vancouver
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Winnipeg
China
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Beijing
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Beijing
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Guangzhou
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Hangzhou
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Hangzhou
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Hangzhou
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Harbin
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Jining
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Nanning
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Wuhan
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Wuhan
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Xi'an
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Yangzhou
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Zhengzhou
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Zhengzhou
Germany
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Bonn
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Cologne
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Essen
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Freiburg Im Breisgau
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Gauting
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Heidelberg
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Ravensburg
Hungary
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Budapest
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Kanazawa
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Nagoya
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Okayama
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Sapporo
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Suwon
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Jerez De La Frontera
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Reus
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Salamanca
Taiwan
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Kaohsiung City
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New Taipei City
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Taichung
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Tainan
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Taoyuan
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Mueang
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Adapazarı
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Ankara
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Ankara
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Antalya
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Diyarbakır
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Istanbul
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Istanbul
United Kingdom
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Cheltenham
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Inverness
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London
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London
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London
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Norwich
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Preston
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Truro
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Da Nang
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Hà Nội
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Hanoi
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Ho Chi Minh City
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Ho Chi Minh City
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Huế
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Vinh
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Vĩnh Yên
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2024-04-11
Estimated Completion Date:2029-12-28
Participants
Target number of participants:675
Treatments
Experimental: Arm 1: Datopotamab Deruxtecan in Combination With Rilvegostomig
Participants in the Datopotamab Deruxtecan (Dato-DXd) in combination with Rilvegostomig group will receive Dato-DXd plus rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Experimental: Arm 2: Rilvegostomig Monotherapy
Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Active_comparator: Arm 3: Pembrolizumab Monotherapy
Participants in the pembrolizumab group will receive pembrolizumab as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.