Clinical trial · Interventional
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
An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)
NCT05048797CI-TRIAL-00117499active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced or Metastatic Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Trastuzumab Deruxtecan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Trastuzumab Deruxtecan (T-DXd)
- interventionNames
- Drug: Trastuzumab Deruxtecan
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Standard of Care Treatment (platinum, pemetrexed and pembrolizumab)
- interventionNames
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Pembrolizumab
- Drug: Pemetrexed
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 123 Years
Show eligibility criteria text
Inclusion Criteria: * Participants at least 18 years of age * Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease * Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA * Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease * Left ventricular ejection fraction (LVEF) ≥ 50% * Measurable disease assessed by Investigator based on RECIST 1.1 * Protocol-defined adequate organ function including cardiac, renal, hepatic function * ECOG 0-1 * Having tumour tissue available for central testing Exclusion Criteria: * Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy) * Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases * Active autoimmune or inflammatory disorders * Medical history of myocardial infarction within 6 months prior to randomization * History of non-infectious pneumonitis/ILD, current or suspected ILD * Lung-specific intercurrent clinical significant severe illness * Contraindication to platinum-based doublet chemotherapy or pembrolizumab
References
Publications (0)
Data not yet available
No reference posted for this study.