Trial Watch: 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
Important context
- Trial eligibility (participation has strict criteria): Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
In plain English
The 30-second version
What happened?
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
Why does it matter?
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
What does this not prove?
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Keep reading for evidence stage, limitations, study details, and sources.
What changed: ClinicalTrials.gov lists 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 (NCT05215340) as a Phase 3 interventional cancer study. The registry status is Active Not Recruiting, with the record last updated 2026-09-24.
Study snapshot: Phase 3; Active Not Recruiting; planned enrollment 740. Conditions listed: Metastatic Non Small Cell Lung Cancer. A primary outcome listed by the registry is: 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.
This entry tracks verified trial-registry facts. Trial registration by itself does not show that an intervention is effective, safe for a particular person, FDA-approved for this use, or recommended by clinical guidelines.
Population / Applicability
Studied in: Participants age 18 Years and older with Metastatic Non Small Cell Lung Cancer who meet the study-specific registry eligibility criteria. (Adults)
Eligibility is study-specific. Registry information does not determine whether any individual should enroll in or receive the intervention.
Full evidence details
- Study design
- Not specified in this summary
- Sample size
- 740
- Primary outcome
- 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
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as Daiichi Sankyo. Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Country or region not specified
- Status
- Investigational
- Last verified
- 2026-09-24
Cancer-type scope for this record is not yet recorded.
Guideline positions
Guideline
- Position
- Not addressed
- Last verified
- 2026-09-24
Primary evidence supporting this story
- ClinicalTrials.gov — NCT05215340 (opens in a new tab) (Clinical-trial registry) NCT05215340 Primary source NCT05215340
ClinicalTrials.gov — NCT05215340. NCT05215340.
Last reviewed
Trial Watch: 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
https://cancerdiscoveries.com/discoveries/trial-watch-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/
Research type: Registered later-phase trial
What This Means
ClinicalTrials.gov confirms that this Phase 3 study is registered and currently listed as Active Not Recruiting. This establishes the study's existence and registry-reported design/status, not a treatment benefit.
What This Doesn't Mean
A registered trial is not proof that the intervention works, is not FDA approval for this cancer or use, and is not a clinical-guideline recommendation.
Why It Matters
Phase 3 trials can contribute later-stage human evidence. CancerDiscoveries can track this record as results and regulatory information emerge.
Important Limitations
- Clinical-trial participation has study-specific eligibility criteria; registry listing does not mean a person qualifies or should enroll.
Primary sources
- ClinicalTrials.gov — NCT05215340 — https://clinicaltrials.gov/study/NCT05215340 (NCT05215340)
Date verified: 2026-09-24
Correction status: No correction or retraction