BridgeMD
A study to investigate the efficacy and safety of trastuzumab deruxtecan as the first treatment option for locally advanced/metastatic Non-Small Cell Lung Cancer with HER2 mutations
EU CTIS ID: 2023-503674-20-00
What this study is testing
To assess the efficacy of T-DXd relative to platinum with pemetrexed plus pembrolizumab by assessment of Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) in participants with unresectable, locally advanced, or metastatic NSCLC harboring HER2 exon 19 or 20 mutations.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male and female participants at least 18 years of age
- Locally advanced 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 (locally or centrally tested)
- 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 v1.1
You likely can't join if
- 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)
- Clinically active brain metastases, defined as untreated AND/OR symptomatic, or requiring therapy to control associated symptoms. All participants with brain metastases must have previously completed local therapy.
- 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
See the full eligibility criteria
- Male and female participants at least 18 years of age
- Locally advanced 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 (locally or centrally tested)
- 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 v1.1
- Protocol-defined adequate organ function including cardiac, renal, hepatic function
- ECOG 0-1
- Having tumour tissue available for central testing
- 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)
- Clinically active brain metastases, defined as untreated AND/OR symptomatic, or requiring therapy to control associated symptoms. All participants with brain metastases must have previously completed local therapy.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Canada
- China
- United States
- Hong Kong
- Mexico
- Japan
- Brazil
- Turkey
- Taiwan
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Canada; China; United States; Hong Kong; Mexico and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.