Trial Watch: A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
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 A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations (NCT05048797) as a Phase 3 interventional cancer study. The registry status is Active Not Recruiting, with the record last updated 2026-10-21.
Study snapshot: Phase 3; Active Not Recruiting; planned enrollment 454. Conditions listed: Locally Advanced or Metastatic Non-Small Cell Lung Cancer. A primary outcome listed by the registry is: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR).
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 ages 18 Years to 123 Years with Locally Advanced or 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
- 454
- Primary outcome
- Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
- Replication
- Unknown
Funding & Conflicts
ClinicalTrials.gov lists the lead sponsor as AstraZeneca. Sponsorship is reported for transparency and does not establish efficacy.
Regulatory status by jurisdiction
Unspecified jurisdiction
- Status
- Investigational
- Last verified
- 2026-10-21
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
- 2026-10-21
Primary evidence supporting this story
- ClinicalTrials.gov — NCT05048797 (opens in a new tab) (Clinical-trial registry) NCT05048797 Load-bearing source NCT05048797
ClinicalTrials.gov — NCT05048797. NCT05048797.
Last reviewed
Trial Watch: A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
https://cancerdiscoveries.com/discoveries/trial-watch-a-study-to-investigate-the-efficacy-and-safety-of-trastuzumab-deruxtecan-as-the-first-treatment-option-for-unresectable-locally-advanced-metastatic-non-small-cell-lung-cancer-with-her2-m/
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 — NCT05048797 — https://clinicaltrials.gov/study/NCT05048797 (NCT05048797)
Date verified: 2026-10-21
Correction status: No correction or retraction