Zolbetuximab + Chemotherapy for Gastric Cancer
(Spotlight Trial)

Recruiting in Palo Alto (17 mi)

+226 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Astellas Pharma Global Development, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?A study of Zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in participants with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why was this study being done? SPOTLIGHT was a new clinical study for adult participants who had any of advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers had 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 participants with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) was a current treatment option. This study was testing an experimental medicine called Zolbetuximab (IMAB362). Zolbetuximab attached itself to Claudin 18.2 on the cancer cells causing cancer cell death. Participants were assigned to one of two groups by chance and given either: Zolbetuximab with mFOLFOX6; or a placebo with mFOLFOX6. A placebo was a treatment that looks like the experimental medicine, but contained no medicine. The goal of the study was to find out if Zolbetuximab with mFOLFOX6 helped participants to live longer by stopping the cancer from getting worse.

Eligibility Criteria

Adults with advanced unresectable or metastatic gastric/GEJ cancer that's HER2-negative and expresses Claudin 18.2 proteins can join this trial. They must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants should not be pregnant, breastfeeding, or planning to donate eggs/sperm; contraception is required. Those who've had certain treatments for these cancers within specific timeframes before the study starts cannot participate.

Inclusion Criteria

I agree not to breastfeed during and for 6 months after the study.

I will not donate eggs during and up to 9 months after my last oxaliplatin dose, and 6 months after other study drugs.

Subject must meet laboratory test criteria within 14 days prior to randomization

+11 more

Exclusion Criteria

I have tested positive for HIV or active hepatitis B or C.

I have been treated for an autoimmune disease in the last 3 months.

I have had chemotherapy for advanced stomach or GEJ cancer that cannot be surgically removed.

+18 more

Participant Groups

The trial tests zolbetuximab (IMAB362), which targets Claudin 18.2 on cancer cells, combined with mFOLFOX6 chemotherapy versus a placebo plus mFOLFOX6 in patients with specific gastric cancers. The goal is to see if zolbetuximab helps extend life by preventing cancer progression.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: mFOLFOX6 + ZolbetuximabExperimental Treatment4 Interventions

Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\^2) on cycle1 day1(C1D1) followed by 600 mg/m\^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 \& 29 of each cycle (5-FU:400mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85mg/m\^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU \& Folinic acid on Days 1, 15 \& 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.

Group II: Placebo plus mFOLFOX6Placebo Group4 Interventions

Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\^2 IV bolus over 5-15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.

Fluorouracil is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as 5-Fluorouracil for: