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Have you or a loved one been recently diagnosed with advanced or metastatic stomach cancer or GEJ cancer?

Then you may be interested in the SPOTLIGHT study. It will test how well an investigational drug works and how safe it is. This website will tell you what you need to know about being in the study.

Study Information Study Participation

About the SPOTLIGHT study

Who is this clinical study for?

Adults with newly diagnosed locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) cancer who:

  • Have not received any prior systemic chemotherapy
  • Have a HER2-negative tumor

This website is for US residents only. Additional sites, not currently listed on this website, may accept patients. Please go to clinicaltrials.gov for more information.

Study Title

A Phase 3 efficacy, safety and tolerability study of zolbetuximab (experimental drug) plus mFOLFOX6 chemotherapy compared to placebo plus mFOLFOX6 as treatment for gastric and gastroesophageal junction (GEJ) cancer

ClinicalTrials.gov

Identifier: NCT03504397

Please note that if you decide to participate in the study you can also choose to stop at any time.

Things to think about before being part of a clinical trial:

Participating in a study requires time and effort for you and your caregivers. Below is important information about the number of visits you can expect during the SPOTLIGHT study period should you decide to participate:

Clinic Visits
The number of clinic visits. Number of visits may be different for each participant. You can talk to the study doctor to learn more.

4 visits

Per cycle*

5 or more

Cycles depending upon
disease status

* 1 treatment cycle lasts 42 days.

What do you need to know about the study?

Purpose of the study

The main purpose of the SPOTLIGHT Study is to gather information about the investigational study drug, zolbetuximab (IMAB362), to see if it is effective in people with locally advanced unresectable or metastatic gastric or GEJ cancer when used in combination with an approved cancer treatment called mFOLFOX6.

Conditions being studied
The disease, disorder, syndrome, illness, or injury that is being studied.

  • Locally Advanced Unresectable Gastric Adenocarcinoma or cancer
  • Metastatic Gastric Adenocarcinoma or cancer
  • Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or cancer

Drugs being tested in the study

Zolbetuximab or placebo, in combination with mFOLFOX6 (fluorouracil, leucovorin, oxaliplatin)

Facts about the study
Clinical trials happen in phases. Each phase has a different goal that helps researchers answer specific questions. For example, in Phase 2, the goal is to find out if the medicine works and learn more about its safety. In Phase 3, the goal is to test the medicine compared to different treatments. Also, researchers can learn more about the medicine's side effects and how to use it safely.

Trial phase

3

Searching for

550

participants
worldwide

What can you expect from being in this study?

Being part of the SPOTLIGHT study takes time and effort for the person participating and their caregiver. You may:

  • be in the study for several years
  • need to travel to the clinical trial site location
  • receive study drug infusions
  • need blood taken or other tests such as heart monitoring. This helps researchers learn how the drug is working

This drug is experimental. Because of that, not all risks are known before starting a clinical trial. People who are in the study may stop at any time.

Why is this study being done?

A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Why is this study being done?

SPOTLIGHT is a new clinical study for adult patients who have any of:
  • advanced unresectable gastric or GEJ cancer
  • metastatic gastric or GEJ cancer
These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells.

For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death.

Patients will be assigned to one of two groups by chance and given either:
  • zolbetuximab with mFOLFOX6; or
  • a placebo with mFOLFOX6
A placebo is a treatment that looks like the experimental medicine, but contains no medicine.

The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.



Patients will receive one of two different treatments by chance Patients will receive one of two different treatments by chance

Could you be a good candidate for this study?

Answer these questions to learn more.

1. Have you been diagnosed with stomach cancer known as either gastric or gastroesophageal junction (GEJ) cancer?
2. Is your stomach cancer advanced or metastatic?
3. Have you received chemotherapy for your stomach cancer in the past 6 months?

Based on your answers, you may be a good candidate for this study.

To find the clinical trial center closest to you, enter your location below.

The clinical trial center will determine your eligibility for participation in this study.

Based on your answers, this study may not be right for you. Please talk to your doctor if you still have questions about the SPOTLIGHT study. Or, if you still think you may be a good candidate for this clinical trial, search below for a clinical trial center near you.

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CLINICAL TRIALS
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Clinical trial centers
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please visit: https://www.astellas.com/us/privacy-policy

If you have questions, please contact your nearest
study center. If you can't
reach them, please call the
Astellas Medical Information team at 1 (800) 727‑7003.
We are available Monday–Friday, 8:00 AM–4:30 PM CT.