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.
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 - 130 Years
- Who can join: All genders
Biomarkers mentioned
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
Where Is This Study? (7 UK sites)
Research Site
Birmingham B9 5SS, United Kingdom
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Glasgow G12 0YN, United Kingdom
Research Site
Leicester LE1 5WW, United Kingdom
Research Site
London EC1A 7BE, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Middlesbrough TS4 3BW, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
