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 who have been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus (called gastric or GEJ adenocarcinoma), confirmed by laboratory testing of a tissue or cell sample.
• People whose cancer has been confirmed by scans to be advanced, unable to be surgically removed, or has spread to other parts of the body, within 28 days before joining the trial.
• People whose doctors estimate they have a life expectancy of at least 12 weeks.
• Women who are not pregnant at the time of screening, confirmed by a blood test, and who are either not able to become pregnant, or who agree to follow strict contraception guidelines from the time of consent until at least 9 months after the last dose of one of the study drugs (oxaliplatin) and 6 months after the last dose of all other study drugs. (Note: special additional testing may allow some participants with unusual hormone results to confirm they are not pregnant and still be considered eligible.)
• Women who agree not to breastfeed from the time of screening until at least 9 months after the last dose of oxaliplatin and 6 months after the last dose of all other study drugs.
• Women who agree not to donate eggs from the first dose of study treatment until at least 9 months after the last dose of oxaliplatin and 6 months after the last dose of all other study drugs.
• Men who agree to use contraception with female partners who could become pregnant (including those who are breastfeeding) throughout treatment and for 6 months after the last dose of study drugs.
• Men who agree to use a condom or remain abstinent with pregnant partners throughout the study and for 6 months after the last dose of study drugs.
• Men who agree not to donate sperm during treatment and for 6 months after the last dose of study drugs.
• People who have disease that can be assessed or measured by scans according to standard guidelines, with scans done within 28 days before joining (with specific conditions if the only detectable area of disease was previously treated with radiation within 3 months).
• People whose tumour has tested negative for a protein called HER2, based on laboratory testing.
• People who have provided a preserved tumour tissue sample that meets the study's laboratory requirements.
• People whose tumour has tested positive for a protein called CLDN18.2, based on central laboratory testing.
• People who have a valid test result for a protein called PD-L1, based on central laboratory testing of a tumour sample.
• People with a known tumour type that has certain DNA repair issues (called microsatellite instability-high or mismatch repair deficient), as long as their tumour also shows a PD-L1 combined positive score of 1 or higher on central testing.
• People with a general health and activity level rated 0 or 1 on a standard medical scale (meaning they are fully active or have only minor limitations in strenuous activity).
• People whose recent blood test results (within 14 days before joining) meet specific laboratory value requirements set out in the study (including a haemoglobin level of at least 9 g/dL after any blood transfusion, measured at least 24 hours after transfusion).

For participants in South Korea specifically:

• People aged 19 or older at the time of signing the consent form.
• Women who are not pregnant and who meet contraception or non-childbearing criteria, with contraception required for at least 15 months after the last dose of oxaliplatin and 6 months after all other study drugs.
• Women who agree not to breastfeed for at least 15 months after the last dose of oxaliplatin and 6 months after all other study drugs.
• Women who agree not to donate eggs for at least 15 months after the last dose of oxaliplatin and 6 months after all other study drugs.
• Men who agree to use contraception with female partners who could become pregnant for 12 months after the last dose of oxaliplatin and 6 months after all other study drugs.
• Men who agree to use a condom or remain abstinent with pregnant partners for 12 months after the last dose of oxaliplatin and 6 months after all other study drugs.
• Men who agree not to donate sperm for 12 months after the last dose of oxaliplatin and 6 months after all other study drugs.

For participants in Japan specifically:

• Women who are not pregnant and who either cannot become pregnant or have a negative pregnancy blood test at screening (including a medical interview), and who agree to follow contraception guidelines until at least 9 months after the last dose of oxaliplatin and 6 months after all other study drugs.

Who may not be able to join:

• People whose cancer is a mixed type or a type that is not classified as adenocarcinoma.
• People with active cancer that has spread to the brain or the lining around the brain and spinal cord. (People with previously treated and stable brain metastases that have not progressed for at least 4 weeks on repeat scans, are clinically stable, and have not needed steroid treatment for at least 14 days before joining may still be considered — confirm with trial site.)
• People who have had a hole or abnormal opening in the digestive tract, untreated stomach ulcers that would prevent participation, an arterial blood clot event within the past 6 months, or a significant bleed or major vein blood clot within the past 3 months.
• People with a complete blockage of the stomach outlet, or a partial blockage with ongoing or repeated vomiting.
• People who already have nerve damage in their hands or feet worse than a mild level (greater than Grade 1 on a standard medical scale).
• People with poorly controlled high blood pressure.
• People with serious heart conditions, including: severe heart failure, a heart attack, unstable chest pain, certain heart procedures or bypass surgery, a stroke, or a hypertensive crisis within the past 6 months; a heart rhythm measurement (QTc interval) that is too long; a personal or family history of a condition called long QT syndrome; certain irregular heart rhythms needing medication (except for well-controlled atrial fibrillation for more than 1 month); reliance on a pacemaker; or a history of serious dangerous heart rhythms.
• People with a known immune system deficiency or an autoimmune disease that has needed systemic medical treatment in the past 2 years. (People who only need simple hormone or gland replacement therapy, such as thyroid hormone or insulin, may still be considered — confirm with trial site.)
• People with mental health conditions or social circumstances that would make it difficult to follow the study requirements.
• People who have had another cancer within the past 3 years, or who still have signs of a previous cancer. (Some exceptions apply, including certain non-aggressive skin cancers, certain prostate cancers with no sign of progression, or cancers that were fully removed — confirm with trial site.)
• People who have had lung inflammation (pneumonitis) that needed steroid treatment in the past, currently have pneumonitis, or have a history of scarring lung disease (interstitial lung disease).
• People with an existing uncontrolled blood clotting disorder, or who are taking blood-thinning medications at a level that makes their clotting time too long (INR greater than 2). (Certain types of blood thinners for vein clots, such as LMWH or direct oral anticoagulants, may be allowed — confirm with trial site.)
• People with a history of abnormal bleeding tendencies or a recent significant bleeding event (Grade 2 or higher) within 28 days before joining.
• People with another serious illness that is not under control.
• People with an active infection requiring systemic (whole-body) medication that has not fully cleared within 7 days before joining.
• People known to have HIV infection, unless their immune cell counts and infection history meet specific criteria set by the trial (confirm with trial site). HIV screening may be required depending on local rules.
• People with active hepatitis B or hepatitis C infection. Specific testing rules apply, and some people with past hepatitis B or successfully treated hepatitis C may still be considered eligible (confirm with trial site). Screening may be required depending on local rules.
• People with a known history of a positive tuberculosis test or an active tuberculosis infection. Screening requirements depend on local rules.
• People with a known complete deficiency of an enzyme called DPD, which affects how certain chemotherapy drugs are processed by the body. Screening requirements depend on local rules. (In the EU, all participants must be tested for this deficiency before receiving fluoropyrimidine-based chemotherapy, in line with European medical guidelines.)
• People with pernicious anaemia or other types of anaemia caused by vitamin B12 deficiency.
• People who have already received chemotherapy or immunotherapy as a treatment for their advanced or spread stomach or GEJ cancer. (A limited exception exists for people who have had at most one cycle of specific chemotherapy combinations, with or without immunotherapy, before joining — confirm with trial site. Previous treatment given before or after surgery at least 6 months ago, with disease progression at least 6 months after the last dose, may also be allowed. Herbal medicines with known anti-cancer activity taken more than 28 days before joining may also be permitted — confirm with trial site.)
• People who have received immune-suppressing medications, including steroid tablets, within 7 days before joining. (Low-dose replacement steroids and certain one-off or pre-procedure uses may be allowed — confirm with trial site.)
• People who have had a major operation within 28 days before joining and have not fully recovered.
• People who have received a treatment specifically targeting CLDN18.2 within 28 days or 5 half-lives of that drug (whichever is longer) before joining, or who have had a serious digestive side effect (Grade 3 or higher) from such a treatment.
• People who have received radiation therapy for their advanced stomach or GEJ cancer within 14 days before joining and have not recovered from the side effects. (A shorter 7-day gap may be allowed for certain shorter-course palliative radiation to areas outside the brain — confirm with trial site.)
• People who have previously received certain types of immunotherapy drugs, such as anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint treatments, unless those treatments were given as part of surgery-related (perioperative) care.
• People who have received a live or live-weakened vaccine within 30 days before joining. (Standard inactivated flu vaccines are allowed.)
• People who have received certain antiviral medicines called brivudine, sorivudine, or related drugs within 28 days or within 5 half-lives of the drug (whichever is shorter) before joining.
• People who have participated in another clinical trial or received an experimental treatment within 28 days before joining, or within 5 half-lives of that experimental drug (whichever is longer).
• People with any other serious condition or health problem that the trial team considers would make participation unsafe or unsuitable.
• People who have had a severe allergic reaction, or who are known or suspected to be allergic, intolerant, or have a medical reason not to take any of the study treatments.

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