Phase 3 Stomach Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People whose gastric cancer tumour tests positive for a protein called HER2.
• People whose tumour has a PD-L1 combined positive score (CPS) of 1 or higher — a measure of how much of a certain protein is present in the tumour (confirm with trial site if unsure what this means for your situation).
• People who can provide a recent tumour tissue sample suitable for HER2 and PD-L1 testing.
• People who have not yet received any treatment for their gastric or gastroesophageal junction (GEJ) cancer, and whose cancer cannot be surgically removed and has either spread to nearby areas or to other parts of the body.
• People who are generally well enough to carry out light activity and care for themselves, based on a standard medical scoring system (performance status of 0 or 1).
• People whose cancer has at least one measurable area that can be tracked on scans, assessed using standard guidelines called RECIST v1.1.
• People whose organs (such as kidneys and liver) and bone marrow are functioning well enough to tolerate treatment.
• People whose heart pumping function (called LVEF) is at least 50%, measured within 28 days before being assigned to a treatment group.
• People who have waited an adequate period of time since their last treatment before joining the trial (confirm specific timeframes with trial site).

Who may not be able to join:

• People who have a structural problem affecting the upper digestive tract that affects how it works normally.
• People who have a known deficiency of an enzyme called dihydropyrimidine dehydrogenase (DPD), which affects how certain chemotherapy drugs are processed by the body.
• People for whom any of the study drugs — pembrolizumab, trastuzumab, fluoropyrimidine-based chemotherapy (5-FU or capecitabine), or platinum-based chemotherapy (cisplatin or oxaliplatin) — are medically unsuitable or contraindicated.
• People with a history of another cancer, unless that cancer was treated with the intention of curing it, has shown no signs of returning for at least 3 years, and carries a low risk of coming back.
• People who still have significant side effects from a previous cancer treatment that have not resolved.
• People with cancer that has spread to the spine or brain, unless it has been treated, is stable, causes no symptoms, and does not require steroids or anti-seizure medications — and the person has recovered from any side effects of radiotherapy to those areas.
• People with an uncontrolled infection, including tuberculosis or active hepatitis A.
• People with an active infection that currently requires intravenous (IV) antibiotics, antiviral, or antifungal treatment.
• People who have recently received a live or live-attenuated vaccine (such as certain flu or travel vaccines).
• People with an ongoing or active hepatitis B (HBV) or hepatitis C (HCV) infection that is not well controlled.
• People with significant heart or mental health conditions (confirm specific conditions with trial site).
• People with active or previously diagnosed autoimmune or inflammatory conditions that require ongoing treatment with steroids or other immune-suppressing medications.
• People with a history of, or current, non-infectious lung inflammation (ILD/pneumonitis), or where this condition cannot be ruled out based on screening scans.
• People with other significant ongoing lung conditions (confirm details with trial site).
• People with an active non-infectious skin condition that requires systemic (whole-body) treatment.
• People who have a build-up of fluid around the lungs, in the abdomen, or around the heart that requires drainage or a specialised procedure to manage.
• People who have previously experienced a severe skin reaction caused by a drug.
• People who are currently receiving any other cancer treatment, with the exception of a specific type of bone-protecting medication called a RANK-L inhibitor.
• People who have had a major surgical procedure recently, have had a significant traumatic injury recently, or are expected to need major surgery during the trial period (routine placement of a vascular access device is excluded from this).
• People who have used immune-suppressing medications within the 14 days before starting the trial treatment.

Important: Always verify eligibility with the trial site directly before applying.