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RECRUITING

NCT06357533

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

675

Start Date

2024-04-11

Completion Date

2029-12-28

Last Updated

2026-09-23

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

Datopotamab Deruxtecan

Datopotamab Deruxtecan IV (intravenous)

DRUG

Rilvegostomig

Rilvegostomig IV (intravenous)

DRUG

Pembrolizumab

Pembrolizumab IV (intravenous)

Inclusion Criteria: * Histologically or cytologically documented non-squamous NSCLC. * Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation. * Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted first-line therapies. * Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers. * Known tumour PD-L1 expression status defined as TC ≥ 50% * At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline * ECOG performance status of 0 or 1 * Adequate bone marrow reserve and organ function Exclusion Criteria: * Prior systemic therapy for advanced/metastatic NSCLC. * Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant. * History of another primary malignancy within 3 years * Active or prior documented autoimmune or inflammatory disorders (with exceptions) * Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol. * Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage. * History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has significant pulmonary function compromise, as determined by the investigator * Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants. * History of leptomeningeal carcinomatosis * Known clinically significant corneal disease * Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled * History of active primary immunodeficiency

Locations (289)

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Anchorage, Alaska, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Springdale, Arkansas, United States

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Anaheim, California, United States

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Beverly Hills, California, United States

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Fountain Valley, California, United States

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Newport Beach, California, United States

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Clermont, Florida, United States

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Gainesville, Florida, United States

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Miami Beach, Florida, United States

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Orange City, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Hinsdale, Illinois, United States

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Noblesville, Indiana, United States

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Paducah, Kentucky, United States

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Annapolis, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Dearborn, Michigan, United States

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Farmington Hills, Michigan, United States

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Grand Rapids, Michigan, United States

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Traverse City, Michigan, United States

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Hattiesburg, Mississippi, United States

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Kansas City, Missouri, United States

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Bozeman, Montana, United States

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Grand Island, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Voorhees Township, New Jersey, United States

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Stony Brook, New York, United States

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Greenville, North Carolina, United States

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Salisbury, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Maumee, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Greenville, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kingwood, Texas, United States

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Odessa, Texas, United States

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Fort Belvoir, Virginia, United States

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Leesburg, Virginia, United States

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Midlothian, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Vancouver, Washington, United States

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Wenatchee, Washington, United States

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Appleton, Wisconsin, United States

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Birtinya, Australia

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Blacktown, Australia

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Clayton, Australia

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Gosford, Australia

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Melbourne, Australia

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South Brisbane, Australia

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Wodonga, Australia

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Innsbruck, Austria

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Krems, Austria

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Linz, Austria

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Rankweil, Austria

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Vienna, Austria

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Vienna, Austria

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Wels, Austria

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Anderlecht, Belgium

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Bruges, Belgium

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Hasselt, Belgium

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La Louvière, Belgium

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Liège, Belgium

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Barretos, Brazil

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Curitiba, Brazil

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Florianópolis, Brazil

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Ipatinga, Brazil

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Natal, Brazil

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Porto Alegre, Brazil

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Rio de Janeiro, Brazil

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Santa Maria, Brazil

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São Paulo, Brazil

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Taubaté, Brazil

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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London, Ontario, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Lévis, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Rimouski, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Chicoutimi, Canada

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Beijing, China

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Beijing, China

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Changchun, China

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Changsha, China

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Chengdu, China

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Chengdu, China

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Chongqing, China

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Fuzhou, China

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Guangzhou, China

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Hangzhou, China

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Hangzhou, China

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Hangzhou, China

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Harbin, China

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Hefei, China

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Hefei, China

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Jinan, China

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Jining, China

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Kunming, China

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Lanzhou, China

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Linhai, China

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Linyi, China

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Nanjing, China

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Nanning, China

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Nanning, China

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Shanghai, China

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Shanghai, China

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Shanghai, China

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Shenyang, China

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Taiyuan, China

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Tianjin, China

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Wenzhou, China

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Wuhan, China

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Wuhan, China

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Wuhan, China

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Wuhan, China

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Xi'an, China

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Yangzhou, China

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Zhengzhou, China

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Zhengzhou, China

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Berlin, Germany

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Bonn, Germany

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Cologne, Germany

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Düsseldorf, Germany

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Essen, Germany

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Freiburg im Breisgau, Germany

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Gauting, Germany

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (289)