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Looking for participantsPhase3

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Sponsor: AstraZeneca

NCT ID: NCT06417814

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
Dato-DXd (drug), Osimertinib (drug), Pemetrexed (drug), Carboplatin (drug)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Dato-DXd — drug: Dato-DXd will be administered as IV infusion. · Osimertinib — drug: Osimertinib will be administered orally. · Pemetrexed — drug: Pemetrexed will be administered as IV infusion. · Carboplatin — drug: Carboplatin will be administered as IV infusion. · Cisplatin — drug: Cisplatin will be administered as IV infusion.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at how well and how safely a drug called Dato-DXd works, either alone or with a drug called osimertinib, compared with standard platinum-based chemotherapy (a combination of two chemotherapy drugs). It is for people with a type of lung cancer called non-small cell lung cancer that has a change (mutation) in a gene called EGFR and has spread or cannot be removed with treatment. The study is run by AstraZeneca.

Who can take part

  • Have non-squamous non-small cell lung cancer confirmed by tissue or cell tests
  • Have a known EGFR mutation linked to sensitivity to EGFR-blocking tablets (such as Ex19del, L858R, G719X, S768I or L861Q, alone or with other EGFR changes, which may include T790M)
  • Have scans showing the cancer got worse outside the brain while taking osimertinib on its own as the most recent treatment
  • Have had 2 or fewer previous courses of EGFR-blocking tablets (osimertinib is the only previous third-generation EGFR tablet allowed)
  • Have at least one tumour that has not been treated with radiotherapy and can be measured on scans
  • Are well enough to care for themselves, with a performance status (a measure of daily activity) of 0 or 1
  • Have bone marrow and organs (such as liver and kidneys) working well enough, checked within 7 days before joining

Who may not be able to

  • Have had chemotherapy, drugs blocking blood vessel growth, immunotherapy or other cancer treatment once the cancer had spread; or platinum chemotherapy before it spread within 12 months of joining
  • Have had another cancer, unless it was treated with the aim of cure and has not been active in the past 2 years
  • Have a severe or uncontrolled illness, such as active bleeding, infection, heart disease, or lung inflammation (pneumonitis)
  • Have a build-up of fluid (such as in the tummy or around the lungs) that cannot be managed with regular draining
  • Have or may have lung inflammation (including from radiation or drugs), or severe lung problems from other illness
  • Have pressure on the spinal cord or unstable cancer spread in the brain
  • Have cancer spread to the brain or spinal fluid that is causing symptoms
  • Have a significant problem with the cornea (the clear front part of the eye)
  • Have an uncontrolled infection or needed antibiotics within 14 days of joining
  • Have HIV that is not well controlled

What taking part involves

  • • Being given Dato-DXd, either on its own or together with osimertinib, or being given platinum-based doublet chemotherapy (two chemotherapy drugs) — which group you are in is decided by chance (at random)
  • • Regular scans and tests to see how well the treatment works and check for side effects
  • • Blood tests within 7 days before joining to check bone marrow and organ function

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part will involve day to day.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 130 Years
Who
All
Number of participants
744
Started
2024-10-04
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic non-small cell lung cancer
  • • Phase3 - 744 participants
  • • This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS)

Who can take part?

  • • Ages 18 Years to 130 Years
  • • Diagnosed with metastatic non-small cell lung cancer

Where?

  • • Birmingham - Research Site
  • • Cambridge - Research Site
  • • Glasgow - Research Site
  • • Leicester - Research Site
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).

More detail

This is a Phase III, open-label, 3-arm, multicenter study assessing the effects of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in participants with epidermal growth factor receptor gene mutation (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on prior osimertinib treatment. Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups: 1. Dato-DXd + osimertinib combination therapy 2. Dato-DXd monotherapy 3. Platinum-based doublet chemotherapy Participants will receive study intervention until Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) -defined radiological progression by the investigator, unacceptable toxicity, or other discontinuation criterion is met. After study intervention discontinuation, all participants will undergo an end of treatment (EoT) visit within 35 days of discontinuation and will be followed up for safety assessments 28 (+ 7) days after their last dose of study intervention.

Metastatic Non-small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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 - 130 Years
  • Who can join: All genders

Biomarkers mentioned

EGFR

What the study is looking for

  • ✓confirmed by testing a sample non-squamous NSCLC.
  • ✓Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment)...
  • ✓Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR...
  • ✓At least one lesion, not previously irradiated, that qualifies as a (standard scan measurements) TL at baseline and can be accurately...
  • ✓World Health Organization (WHO)/activity scale (ECOG) performance status of 0 or 1.

Who cannot take part

  • ✗History of another primary cancer except for cancer treated with curative intent with no known active...
  • ✗Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases,...
  • ✗Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the...
  • ✗Has severe lung function compromise resulting from intercurrent lung illnesses.
  • ✗Unstable spinal cord compression and/or unstable brain metastases.
See the full criteria
Inclusion Criteria: * Histologically or cytologically confirmed non-squamous NSCLC. * Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutations, which may include T790M). * Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting. * Less than or equal to (\<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI). * At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline. * World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow reserve and organ function within 7 days before randomization. Exclusion Criteria: * Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention. * Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease. * Has significant third-space fluid retention (example \[eg.\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage. * History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses. * Unstable spinal cord compression and/or unstable brain metastases. * Participants with symptomatic brain metastases (including leptomeningeal involvement). * Clinically significant corneal disease. * Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization. * Has known human immunodeficiency virus (HIV) infection that is not well controlled.

Where Is This Study? (7 UK sites)

Research Site

Birmingham B9 5SS, United Kingdom

Recruiting

Research Site

Cambridge CB2 0QQ, United Kingdom

Recruiting

Research Site

Glasgow G12 0YN, United Kingdom

Recruiting

Research Site

Leicester LE1 5WW, United Kingdom

Recruiting

Research Site

London EC1A 7BE, United Kingdom

Recruiting

Research Site

Manchester M20 4BX, United Kingdom

Recruiting

Research Site

Middlesbrough TS4 3BW, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05