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

Evidence stage: Later-Stage HumanRegulatory status: InvestigationalGuideline status: Not addressed

Important context

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.

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.

Promise & Proof

Proof — strength of the evidence 4 / 5
  • Base score from evidence stage: Later-Stage Human.
Promise — potential significance if later evidence holds up 3 / 5
  • Baseline — a validly-evidenced story starts here; every further point below is an explicit, checkable reason.
  • The record includes substantive editorial reasoning about why this discovery matters.
  • Targets a cancer type with historically limited effective treatment options.

These two ratings are automatically computed from this story's own structured evidence fields and are shown separately on purpose — they are never combined into one score. They describe this record, not a medical recommendation: they do not establish medical certainty, do not substitute for reading the cited sources, and are recalculated whenever the underlying evidence changes.

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
Other / not applicable
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

Unspecified jurisdiction

Status
Investigational
Last verified
2026-09-24

This record has no structured cancer-type scope on file yet — editorial review recommended before treating it as applicable to a specific cancer type.

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-09-24

Primary evidence supporting this story

Why Should I Trust This?

  • 1 source at Tier 1 — Government/regulatory authority (FDA, NCI, NIH, ClinicalTrials.gov, CDC, and equivalent)
  • Correction/retraction status: No correction or retraction
  • Last reviewed: 2026-09-24

This panel summarizes real, checkable facts about this record's own sources and review status — it is not a trust score, and reading it is not a substitute for reading the cited sources yourself.

Discovery Timeline

Every recorded change to this record's content or publication status, in order.

  1. Status change — Status changed from "Legacy / Unverified" to "In editorial review".
  2. Status change — Status changed from "In editorial review" to "Verified".

Last reviewed

Related 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

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/

Evidence stage: Later-Stage Human

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