Ongoing Clinical Trials for HER2 Positive Gastric Cancer
There are currently 5 clinical trials recruiting patients with HER2 positive gastric cancer across multiple European countries. These studies are testing new treatment combinations including targeted therapies like trastuzumab deruxtecan and rilvegostomig, immunotherapy agents such as pembrolizumab, and various chemotherapy regimens, with the goal of improving outcomes for patients with this type of stomach or gastroesophageal junction cancer.
Clinical trial locations
- Austria
- Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer
- Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
- Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer
- Belgium
- Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer
- Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
- Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors
- Czechia
- France
- Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer
- Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
- Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors
- Germany
- Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer
- Study of Pembrolizumab, Trastuzumab, and Drug Combination for Patients with HER2-Positive, Localized Esophagogastric Cancer
- Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
- Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer
- Hungary
- Italy
- Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer
- Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
- Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Spain
- Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer
- Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
- Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors
Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer
This trial is testing a new combination of treatments for patients with advanced stomach cancer that cannot be removed by surgery. The study compares a new treatment approach using rilvegostomig, fluoropyrimidine, and trastuzumab deruxtecan against the current standard treatment, which includes trastuzumab, chemotherapy, and pembrolizumab.
Who can participate: Patients with HER2-positive gastric or gastroesophageal junction cancer that is either locally advanced or has spread to other parts of the body are eligible. Participants must not have received prior treatment for this cancer and must have a PD-L1 combined positive score of 1 or higher. Adequate organ and bone marrow function is required, along with a heart function measurement of 55% or higher. Both male and female participants of appropriate age can join.
Who cannot participate: The study excludes patients with any cancer type other than HER2-positive gastric or gastroesophageal junction cancer, those who have previously received treatment with the study drugs, individuals with severe uncontrolled medical conditions, pregnant or breastfeeding women, and those unable to comply with study procedures or follow-up visits.
What the trial involves: The main goal is to evaluate whether the new combination of rilvegostomig, fluoropyrimidine, and trastuzumab deruxtecan can improve how long patients live without their cancer worsening compared to standard treatment. Participants will be randomly assigned to one of the two treatment groups and receive their medications through intravenous infusions. Regular monitoring will track treatment effectiveness and any side effects experienced.
Medications being tested: The investigational drugs include rilvegostomig, a targeted therapy being studied for its potential effectiveness against HER2-positive cancer; fluoropyrimidine, a chemotherapy drug that interferes with cancer cell growth; trastuzumab deruxtecan, which combines HER2 targeting with chemotherapy delivery directly to cancer cells; trastuzumab, which targets the HER2 protein on cancer cells; and pembrolizumab, an immunotherapy that helps the immune system recognize and attack cancer.
Study of Trastuzumab Deruxtecan and Drug Combination for Patients with Advanced or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
This clinical trial explores treatment options for patients with advanced stomach cancer or cancer at the junction where the stomach meets the esophagus. The study compares a new treatment combination involving trastuzumab deruxtecan along with chemotherapy, with or without pembrolizumab, against the current standard treatment of chemotherapy and trastuzumab, with or without pembrolizumab.
Who can participate: Eligible participants must be at least 18 years old with advanced stomach or gastroesophageal junction cancer that is HER2-positive and cannot be surgically removed. They must not have received prior treatment for their advanced cancer, have adequate organ and bone marrow function, and maintain a heart function measurement of at least 50%. Participants must also have measurable disease and a tumor sample tested for PD-L1 expression.
Who cannot participate: The trial excludes patients with other types of cancer, those who have had recent cancer treatment, individuals with serious heart problems or uncontrolled high blood pressure, those with active infections requiring treatment, pregnant or breastfeeding women, and patients with allergies to the study medications or history of severe allergic reactions.
What the trial involves: The study aims to determine the effectiveness of trastuzumab deruxtecan combined with chemotherapy and potentially pembrolizumab in treating previously untreated advanced disease. Participants will receive their treatments through intravenous injections and will be monitored regularly through clinic visits, blood tests, and imaging scans. The trial will last up to 60 weeks, during which participants will complete questionnaires about their well-being and side effects.
Medications being tested: The trial is investigating trastuzumab deruxtecan, an antibody-drug conjugate that targets HER2-positive cancer cells and delivers chemotherapy directly to them; pembrolizumab, an immunotherapy that helps the immune system attack cancer cells; and trastuzumab, which targets the HER2 protein to slow cancer cell growth.
Study on Long-Term Safety of Trastuzumab Deruxtecan for Patients with Advanced HER2-Positive or HER2-Mutated Solid Tumors
This trial focuses on monitoring the long-term safety of trastuzumab deruxtecan for patients with advanced cancers that express or have mutations in the HER2 protein. The study provides continued access to this treatment for patients who are already benefiting from it in previous studies.
Who can participate: Participants must currently be enrolled in a specific previous study that has reached a certain stage and must be experiencing clinical benefit from the treatment without signs of disease progression. Those who can have children must agree to use highly effective birth control during the study and for several months after the last dose. Women must have negative pregnancy tests throughout the study period.
Who cannot participate: The study excludes patients whose cancer is not advanced or cannot be surgically removed, those whose cancer does not show HER2 expression or mutations, individuals who are no longer benefiting from the treatment, and those who have not been monitored for long-term safety while on the treatment.
What the trial involves: The main objective is to gather information on the long-term safety of continued treatment with trastuzumab deruxtecan. Participants will continue receiving the medication through intravenous infusions and will be regularly monitored by healthcare professionals. The study will track any adverse events or health changes that occur during the treatment period.
Medications being tested: The study is monitoring trastuzumab deruxtecan, an established medication used for treating HER2-positive cancers. It works by binding to the HER2 protein on cancer cells and delivering chemotherapy directly to these cells, combining targeted therapy with traditional chemotherapy in a single medication.
Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer
This clinical trial investigates whether trastuzumab deruxtecan combined with other medications can be safely and effectively administered before surgery to patients with removable stomach or esophageal cancer. The study will evaluate if this combination therapy helps reduce the cancer before surgical removal.
Who can participate: Patients must be at least 18 years old with locally advanced cancer of the stomach or gastroesophageal junction that can be surgically removed and has not spread to distant areas in the abdomen. The cancer must be HER2-positive, and participants must have an ECOG performance status of 0 or 1, meaning they are either fully active or have some symptoms but can carry out light work. Adequate blood, liver, and kidney function are required.
Who cannot participate: The trial excludes patients who do not have HER2-positive cancer, those whose cancer cannot be removed by surgery, patients without locally advanced disease, individuals not within the specified age range, and those who cannot safely undergo the treatment regimens being tested.
What the trial involves: The study aims to evaluate the safety and effectiveness of administering trastuzumab deruxtecan combined with fluorouracil, calcium folinate pentahydrate, and oxaliplatin before surgery. Participants will receive these medications through intravenous infusion under medical supervision. Throughout the treatment, regular monitoring will assess safety and effectiveness, including checking for side effects and evaluating the cancer’s response. Following the treatment, an evaluation will determine if the tumor can be completely removed surgically.
Medications being tested: The investigational drug is trastuzumab deruxtecan, a targeted therapy that combines an anti-HER2 antibody with a chemotherapy drug. This combination helps deliver chemotherapy directly to cancer cells while minimizing damage to healthy cells, potentially improving treatment effectiveness.
Study of Pembrolizumab, Trastuzumab, and Drug Combination for Patients with HER2-Positive, Localized Esophagogastric Cancer
This trial examines the effectiveness of combining pembrolizumab and trastuzumab with the FLOT chemotherapy regimen for patients with localized cancer affecting the area where the esophagus meets the stomach. The study aims to assess whether this combination can prevent cancer recurrence and achieve complete response after treatment.
Who can participate: Eligible participants must be at least 18 years old with a confirmed diagnosis of HER2-positive adenocarcinoma of the gastroesophageal junction or stomach that can be surgically removed and does not involve distant spread. Patients must be candidates for curative surgery and have an ECOG performance status of 0 or 1. They must not have received any previous cancer treatment such as chemotherapy or radiotherapy, and must have adequate organ function.
Who cannot participate: The study excludes patients with any cancer type other than HER2-positive, localized esophagogastric adenocarcinoma, those who have had previous cancer treatment, individuals with serious heart problems or uncontrolled infections, pregnant or breastfeeding women, and those unable to follow study procedures.
What the trial involves: The main focus is to assess how well the combination of pembrolizumab, trastuzumab, and FLOT chemotherapy works in preventing cancer recurrence and achieving complete response after surgery. Participants will receive treatments through intravenous infusions both before and after surgical removal of the tumor. Regular follow-up appointments will monitor health and treatment effectiveness, with any side effects recorded and managed according to study guidelines.
Medications being tested: The trial is testing pembrolizumab, an immunotherapy that helps the immune system recognize and attack cancer cells; trastuzumab, a targeted therapy that attaches to the HER2 protein on cancer cells to slow their growth; and FLOT, a combination of four chemotherapy drugs that work together to kill cancer cells and stop them from growing.
Summary
The five ongoing clinical trials for HER2 positive gastric cancer demonstrate significant research activity across Europe, with Germany participating in four out of five trials, indicating strong engagement in this area. The trials are distributed across 14 European countries, with Austria, Belgium, France, Italy, and Spain each hosting three studies.
A notable trend is the focus on trastuzumab deruxtecan, which appears in four of the five trials, suggesting strong interest in this antibody-drug conjugate as a potential treatment option. The combination of targeted therapies with immunotherapy, particularly pembrolizumab, is also being extensively investigated. The trials address different stages of the disease, from resectable localized cancer to advanced or metastatic disease, providing a comprehensive approach to treatment development.
Three trials focus specifically on patients who have not received prior treatment for their advanced cancer, while one examines long-term safety for patients already benefiting from treatment. This range of study designs reflects efforts to optimize treatment at various points in the disease course and to understand both effectiveness and safety profiles of new therapeutic approaches.
