# Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionab

Source: https://onco.cc/trials/nct05215340/  
OnCo record `nct05215340` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Datopotamab deruxtecan, Pembrolizumab in non-small-cell lung cancer and small-cell lung cancer, run by Daiichi Sankyo, active and no longer recruiting.

## Summary

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations. ClinicalTrials.gov record last updated 2026-09-24: active not recruiting. Enrollment is actual at 740 participants. Primary completion is estimated at 2030-03-04. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: Datopotamab Deruxtecan, Pembrolizumab. Registered primary measures: Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab; Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-10-06
- Also known as: TROPION-Lung08
- Tags: ctgov-ingest
- Registry id: NCT05215340
- Phase: 3
- Setting: Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
- Sponsor: Daiichi Sankyo
- Enrolled: 740

## Notes

- ClinicalTrials.gov record last updated 2026-09-24: active not recruiting. Enrollment is actual at 740 participants. Primary completion is estimated at 2030-03-04. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications.

## Sources

- ClinicalTrials.gov NCT05215340: https://clinicaltrials.gov/study/NCT05215340

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [PD-L1-high non-small-cell lung cancer without a driver mutation](https://onco.cc/cancers/pdl1-high-nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [TROP2](https://onco.cc/targets/trop2/)
- drugs: [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Daiichi Sankyo](https://onco.cc/companies/daiichi-sankyo/)

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JSON: https://onco.cc/api/v1/entities/nct05215340.json