CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 740 enrolled / 740 target
Drug / intervention
Datopotamab Deruxtecan +1 moredrug
Likely dose
Pembrolizumab 200 mg IV every 3 weeks + Datopotamab Deruxtecan (Dato-DXd) 6.0 mg/kg IV every 3 weeksAI-extracted
Key inclusion· 9
  • ✓Histologically documented non-squamous NSCLC (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0)
  • ✓Stage IIIB/IIIC not candidates for surgery/chemoradiation, or Stage IV NSCLC
  • ✓Documented negative EGFR, ALK, ROS1 testing; no known AGAs in NTRK, BRAF, RET, MET, or other actionable driver kinases with locally approved therapies
  • ✓PD-L1 high expression (TPS ≥50%) by central IHC 22C3 pharmDx assay
Key exclusion· 12
  • ✕Prior systemic treatment for advanced or metastatic NSCLC
  • ✕Prior topoisomerase I-targeted chemotherapy in any setting (adjuvant/neoadjuvant/advanced)
  • ✕Prior TROP2-targeted therapy
  • ✕Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or other checkpoint inhibitors (CTLA-4, OX40, CD137, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05215340
NCT05215340Phase 3ActiveOn Track (14.3/mo)
CompareCT.gov

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

Daiichi Sankyo·interventional·Posted Jan 31, 2022·Updated Jun 12, 2026

In Brief

A Phase 3 clinical trial evaluating Datopotamab Deruxtecan and Pembrolizumab for Metastatic Non Small Cell Lung Cancer. Active but no longer recruiting, targeting 740 participants across 234 sites in 28 countries.

Detailed Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC) of non-squamous histology.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Non Small Cell Lung Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
CollaboratorsAstraZeneca, Merck Sharp & Dohme LLC

Timeline

Phase 3Active
20222023202420252026202720282029203020312032
First PostedJan 31, 2022
Enrollment StartMar 4, 2022
Primary CompletionMar 4, 2030
Study CompletionMar 4, 2032
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 4.4 years agoPrimary completion in 3.7 years

Arms & Interventions

Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd)experimental

Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.

Drug: Datopotamab DeruxtecanDrug: Pembrolizumab
Pembrolizumbactive_comparator

Participants will be randomized to receive 200 mg pembrolizumab.

Drug: Pembrolizumab

Interventions

Datopotamab Deruxtecandrug

Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Pembrolizumabdrug

Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.