At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Trastuzumab Deruxtecan (drug), pembrolizumab (drug), Pemetrexed (drug), Platinum Chemotherapy (drug)
- How long the study runs
- Study runs about 85 months (dates as stated)
- About the drug or intervention
- Trastuzumab Deruxtecan — drug: T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W) · pembrolizumab — drug: pembrolizumab will be administered at a dose of 200 mg IV Q3W · Pemetrexed — drug: Pemetrexed will be administered at a dose of 500 mg/m\^2 IV Q3W · Platinum Chemotherapy — drug: One of the following two will be administered in Arm B: Cisplatin at a dose of 75 mg/m\^2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV Q3W
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 686
- Started
- 2025-10-24
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase3 - 686 participants
- • This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Eastbourne - Eastbourne District General Hospital
- • London - Charing Cross Hospital
- • Londonderry - Altnagelvin Area Hospital
- • Nottingham - Nottingham University Hospitals City Campus
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ if the participant's most recent archival tumor tissue sample cannot be supplied
What the study is looking for
- ✓Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior...
- ✓Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner...
- ✓Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of...
- ✓Histologically documented non-squamous that has grown locally unresectable or that has spread
- ✓NSCLC and meets all of the following criteria:
Who cannot take part
- ✗Has a QTc prolongation to \>480 ms based on the average of the Screening triplicate 12- lead ECG.
- ✗Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where...
- ✗Has clinically severe lung compromise resulting from intercurrent, lung illnesses including, but not...
- ✗Any underlying lung disorder (eg, lung emboli within 3 months of the trial randomization, severe asthma,...
- ✗Any auto immune, connective tissue, or inflammatory disorders with potential lung involvement (eg, rheumatoid...
See the full criteria
Where Is This Study? (4 UK sites)
Eastbourne District General Hospital
Eastbourne BN21 2UD, United Kingdom
Jo-Anne Taylor
esh-tr.researchanddevelopment@nhs.net0300 13 14 500 ext 771439Charing Cross Hospital
London, United Kingdom
Altnagelvin Area Hospital
Londonderry BT47 6SB, United Kingdom
Nottingham University Hospitals City Campus
Nottingham NG5 1PB, United Kingdom
How to Get in Touch
Contact for Trial Information
Sponsor contactCONTACT
