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Looking for participantsPhase3

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Sponsor: Daiichi Sankyo

NCT ID: NCT06899126

View on ClinicalTrials.gov ↗

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.

Non-small Cell Lung Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

HER2PD-L1

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
Inclusion Criteria: 1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable. 2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old. 3. Histologically documented non-squamous locally advanced unresectable or metastatic NSCLC and meets all of the following criteria: Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on the local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting. Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if non-squamous NSCLC is the predominant histology. Mixed tumors will be classified based on the predominant cell type. 4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose if their disease has progressed at least 6 months after the last dose date of adjuvant/neoadjuvant therapy. 1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I. 2. HER2-targeted antibody-based anticancer therapy. 5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied. Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual. Exclusion Criteria: 1. Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period. 2. Has a QTc prolongation to \>480 ms based on the average of the Screening triplicate 12- lead ECG. 3. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 4. Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to: 1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion). 2. Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis). Severe conditions are those defined as impacting daily activities and/or requiring use of supplemental oxygen. 5. Had a prior complete pneumonectomy.

Where Is This Study? (4 UK sites)

Eastbourne District General Hospital

Eastbourne BN21 2UD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jo-Anne Taylor

esh-tr.researchanddevelopment@nhs.net0300 13 14 500 ext 771439

Charing Cross Hospital

London, United Kingdom

Recruiting

Altnagelvin Area Hospital

Londonderry BT47 6SB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mary Mc Gonigle

research.office@westerntrust.hscni.net028 71611362

Nottingham University Hospitals City Campus

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

How to Get in Touch

Contact for Trial Information

Sponsor contact

CONTACT

908-992-6400 CTRinfo_us@daiichisankyo.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09