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A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2-overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer. (DESTINY-Lung06)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515658-26-00
Acronym
DS8201-793
Enrollment
159
Registered
2025-10-06
Start date
2026-01-21
Completion date
Unknown
Last updated
2025-12-10

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

Conditions

Unresectable or Metastatic HER2 overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer

Brief summary

Progression-free survival (PFS) by BICR. PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause. Tumor response will be determined by BICR assessment of tumor scans using RECIST v1.1.

Detailed description

Overall Survival (OS). OS is defined as the time interval from the date of randomization to the date of death due to any cause.

Interventions

DRUGCARBOPLATIN
DRUGDS-8201a
DRUGPEMBROLIZUMAB
DRUGCISPLATIN
DRUGPEMETREXED

Sponsors

Daiichi Sankyo Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-free survival (PFS) by BICR. PFS is defined as the time interval from the date of randomization to the date of radiographic disease progression or death due to any cause. Tumor response will be determined by BICR assessment of tumor scans using RECIST v1.1.

Secondary

MeasureTime frame
Overall Survival (OS). OS is defined as the time interval from the date of randomization to the date of death due to any cause.

Countries

Belgium, France, Germany, Greece, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 3, 2026