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:

• You must be willing to sign consent forms before any trial-related testing or procedures begin.
• You must be 18 years of age or older when you sign the consent form.
• You have stomach (gastric) or gastroesophageal junction (GEJ) cancer that cannot be removed by surgery and has either spread to nearby areas or to other parts of the body, and you have not yet received treatment for this advanced stage — though prior treatment given around the time of surgery is allowed if it ended more than 6 months before your cancer came back.
• Your cancer must test positive for a protein called HER2, confirmed by a central laboratory test on a tumor tissue sample.
• Your tumor must be tested for a protein called PD-L1 by a central laboratory — different levels of PD-L1 may place you in different groups within the trial (confirm with trial site).
• You must be able to provide a tumor tissue sample (either from a previous biopsy or a new one) for central laboratory testing.
• You must have at least one measurable tumor that can be seen on a CT or MRI scan.
• Your heart must be pumping at least 50% efficiently, confirmed by a heart scan taken within 28 days before joining the trial.

Who may not be able to join:

• You have previously received any treatment that specifically targets HER2, including a type of drug called an antibody-drug conjugate (ADC).
• You have a serious condition affecting how your upper digestive system absorbs food (such as severe Crohn's disease), which could prevent you from taking one of the chemotherapy medicines used in this trial in pill form.
• You have a known deficiency of an enzyme called DPD, which affects how your body processes certain chemotherapy drugs (confirm with trial site, as testing requirements vary by country).
• You have a medical reason why you cannot take any of the specific drugs used in this trial — trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin.
• You have had a heart attack within the past 6 months, or you currently have moderate to severe heart failure with symptoms.
• Your heart's electrical activity shows an abnormal reading (called a prolonged QT interval) on an ECG, above specific limits depending on your sex (confirm with trial site).
• You have a history of lung inflammation (not caused by infection) that needed steroid treatment, or you currently have lung inflammation, or lung inflammation cannot be ruled out at screening.
• You have a significant ongoing lung condition, such as a blood clot in the lungs within the last 3 months, severe asthma, severe chronic obstructive pulmonary disease, restricted lung function, or fluid around the lungs.

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