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A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505993-14-00
Acronym
D926NC00001
Enrollment
442
Registered
2024-06-04
Start date
2023-01-05
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Progression-Free Survival as assessed by BICR in non-squamous TROP2 biomarker positive analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous TROP2 biomarker positive analysis set, defined as the time from randomisation until the date of death due to any cause, Progression-Free Survival as assessed by BICR in non-squamous full analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous full analysis set, defined as the time from randomisation until the date of death due to any cause

Detailed description

Progression-Free Survival as assessed by BICR, Overall Survival, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Time to second progression or death in ITT and TROP2 biomarker-defined populations, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Progression-Free Survival 2 in the non-squamous population, Clinical Outcome Assessments as measured by the NSCLC-SAQ and PROMIS Physical Function short form 8c., Pharmacokinetics and immunogenicity

Interventions

DRUGPEMETREXED
DRUGDatopotamab deruxtecan
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGMYCOPHENOLATE MOFETIL
DRUGINFLIXIMAB
DRUGCISPLATIN
DRUGCARBOPLATIN
DRUGPACLITAXEL
DRUGPEMBROLIZUMAB

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival as assessed by BICR in non-squamous TROP2 biomarker positive analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous TROP2 biomarker positive analysis set, defined as the time from randomisation until the date of death due to any cause, Progression-Free Survival as assessed by BICR in non-squamous full analysis set, defined as time from randomisation until progression per RECIST 1.1 or death due to any cause., Overall Survival in non-squamous full analysis set, defined as the time from randomisation until the date of death due to any cause

Secondary

MeasureTime frame
Progression-Free Survival as assessed by BICR, Overall Survival, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Time to second progression or death in ITT and TROP2 biomarker-defined populations, Objective Response Rate as determined by BICR, Duration of Response as assessed by BICR and investigator assessment, Progression-Free Survival as assessed by investigator assessment, and Progression-Free Survival 2 in the non-squamous population, Clinical Outcome Assessments as measured by the NSCLC-SAQ and PROMIS Physical Function short form 8c., Pharmacokinetics and immunogenicity

Countries

Austria, Bulgaria, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026