Novel perioperative drug combinations for locally advanced resectable gastric and gastroesophageal junction adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, open-label, multi-center platform tests multiple novel agents or combinations as perioperative therapy for patients with locally advanced resectable gastric, gastroesophageal junction, or esophageal adenocarcinoma who are treatment-naïve. Participants are assigned into one of three biomarker-driven sub-studies (CLDN18.2-positive/HER2-negative, HER2-positive, or unselected) and receive the recommended dose confirmed by a Safety Review Committee. The protocol collects data on safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity before and after surgery. Individual sub-studies can add or compare different agents such as trastuzumab deruxtecan, AZD0901, rilvegostomig, capecitabine, or 5-FU.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease
* Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ and bone marrow function
* Body weight \> 35 kg

Exclusion Criteria:

* Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.
* Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment
* Central nervous system (CNS) pathology
* Uncontrolled infections
* Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis
* History of another primary malignancy
* Participants with any known or suspicious distant metastasis
* Uncontrolled hepatitis B and/or chronic or active hepatitis B
* Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention

Where it's running

• Research Site
  Newark, Delaware, United States Recruiting
• Research Site
  Washington D.C., District of Columbia, United States Recruiting
• Research Site
  Fairway, Kansas, United States Recruiting
• Research Site
  North Shores, Michigan, United States Recruiting
• Research Site
  Pittsburgh, Pennsylvania, United States Recruiting
• Research Site
  Montreal, Quebec, Canada Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.