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
- Fluorouracil (5-FU) (drug), Capecitabine (drug), Durvalumab (biological), Oxaliplatin (drug)
- How long the study runs
- Study runs about 83 months (dates as stated)
- About the drug or intervention
- Fluorouracil (5-FU) — drug: 5-FU: administered as an IV infusion · Capecitabine — drug: Capecitabine: administered orally · Durvalumab — biological: Durvalumab: administered as an IV infusion · Oxaliplatin — drug: Oxaliplatin: administered as an IV infusion · Trastuzumab — biological: Trastuzumab: administered as an IV infusion · Trastuzumab deruxtecan — drug: T-DXd: administered as an IV infusion · Cisplatin — drug: Cisplatin: administered as an IV infusion · Pembrolizumab — biological: Pembrolizumab: administered as an IV infusion · Volrustomig — biological: Volrustomig: administered as an IV infusion · Rilvegostomig — biological: Rilvegostomig: administered as an IV infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at how safe and useful combinations of a drug called T-DXd are for people with advanced stomach cancer, including cancer where it cannot be removed by surgery or has spread. The trial has different parts: some for people whose cancer has high levels of a protein called HER2, and some for people with lower levels. It is run by AstraZeneca.
Who can take part
- Adults aged 18 or over (other age rules may apply locally)
- Advanced stomach or food-pipe cancer (adenocarcinoma of the stomach, gastro-oesophageal junction, or oesophagus) that cannot be removed by surgery or has spread
- Cancer tissue tests showing either HER2-positive or HER2-low, depending on the trial part
- Some parts need prior treatment with trastuzumab; other parts are for people not yet treated for cancer that has spread
- Measurable disease on scans, judged by the study doctor
- Good enough bone marrow, heart, kidney and liver function as set out in the study plan
- If you could have children, you must use highly effective contraception or avoid sex during and after the study
Who may not be able to
- HIV, hepatitis B or hepatitis C infections (rules differ by trial part)
- Other serious illness that is not under control
- Current or past inflammation or scarring of the lungs (pneumonitis or interstitial lung disease), or suspected cases that cannot be ruled out by scans
- Serious lung illnesses
- Infection needing treatment through a drip (into a vein)
- Fluid build-up around the lungs, in the tummy, or around the heart that needs draining, a shunt, or reinfusion therapy
- Spinal cord compression or active cancer spread to the brain or spinal cord that is causing symptoms
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.
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
- 452
- Started
- 2020-06-03
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for gastric cancer
- • Phase2 - 452 participants
- • DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients
Who can take part?
- • Ages 18 Years to 130 Years
- • Diagnosed with gastric cancer
Where?
- • Cambridge - Research Site
- • Dundee - Research Site
- • London - Research Site
- • Manchester - Research Site
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in HER2-expressing advanced/metastatic gastric/gastroesophageal junction (GEJ) and esophageal adenocarcinoma patients. Study hypotheses: Combination of T-DXd with cytotoxic chemotherapy and/or immunotherapy administered to subjects at the recommended phase 2 dose will show manageable safety and tolerability and preliminary anti-tumor efficacy so as to permit further clinical testing. T-DXd in combination with cytotoxic chemotherapy or immune checkpoint inhibitor administered to HER2-expressing gastric, GEJ and esophageal cancer patients who have not received prior treatment for advanced/metastatic disease will show preliminary evidence of anti-tumour activity and the potential to become a therapeutic option for this patient population.
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
- ✓Male and female participants must be at least 18 years of age. Other age restrictions may apply as per local regulations
- ✓Disease Characteristics:
- ✓that has grown locally, unresectable, or that has spread disease based on most recent imaging
- ✓For Part 1, 2, 3a, 4a pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-positive (IHC 3+...
- ✓For Part 3b,4b and Part 5, pathologically documented adenocarcinoma of the stomach/GEJ/esophagus, HER2-low (IHC...
Who cannot take part
- ✗Uncontrolled intercurrent illness.
- ✗History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging...
- ✗Lung-specific intercurrent clinically significant severe illnesses.
- ✗Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- ✗Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and...
See the full criteria
Where Is This Study? (5 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
Dundee DD1 9SY, United Kingdom
Research Site
London NW1 2PG, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom
Research Site
Sutton SM2 5PT, United Kingdom
