A Study of Amivantamab in People With Esophagogastric Cancer (NCT05117931) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Amivantamab in People With Esophagogastric Cancer
United States25 participantsStarted 2021-12-02
Plain-language summary
The purpose of this study is to see whether the study drug, amivantamab, is an effective treatment for people with EGFR- or MET-amplified esophagogastric cancer. The researchers will also look at whether amivantamab is a safe treatment that causes few or mild side effects in participants.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject or legally authorized representative is willing and able to provide written informed consent.
* Patients with previously treated metastatic or unresectable histologically-confirmed esophagogastric cancer who have received at least 1 line of therapy.
* EGFR or MET amplification by tissue-NGS with copy number \>8 and/or ctDNA amplification by any FDA and CLIA-approved assay
* No prior receipt of an EGFR or MET inhibitor for esophagogastric cancer. (Note: if a patient previously received a EGFR inhibitor, but subsequently demonstrated a MET amplification, or previously received a MET inhibitor, but subsequently demonstrated an EGFR-amplification, inclusion is permitted).
* Patients with HER2+ (IHC 3+ or IHC 2+/FISH+) tumors must have progressed on trastuzumab.
* Measurable disease based on RECIST 1.1.
* ≥ 18 years of age on day of signing informed consent.
* Have an ECOG performance status of 0, 1, or 2.
* Adequate organ function, defined as:
A. Hemoglobin ≥9 g/dL
B. ANC ≥1.0 x 10\^9 /L
C. Platelets ≥75 x 10\^9 /L
D. AST and ALT ≤3 x ULN (≤5 x ULN for subjects with liver metastases)
E. Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits
F. Serum creatinine \<1.5 x ULN or if available, calculated or measured creatinine clearance \>50 mL/min/1.73 m\^2
* Women of childbearing potential and male patients with women of childbearing potential partners must be willing to use an ade…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.