Trial · NCT03504397

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

NCT03504397, Phase 3, Active not recruiting, Astellas Pharma Global Development, Inc.; results first posted 2025-02-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. Trials, record NCT03504397. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03504397

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
NCT number: NCT03504397
Status: Active not recruiting
Phases: Phase 3
Enrollment: 565 participants, actual
Lead sponsor: Astellas Pharma Global Development, Inc.
Conditions: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
Interventions: zolbetuximab, placebo, oxaliplatin, folinic acid, fluorouracil
First posted: 2018-04-20
Last updated: 2026-10-20
Other registries' IDs: eudract:2017-002567-17
Results first posted: 2025-02-26

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression Free Survival (PFS)	From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)	PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 by independent review committee \[IRC\]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan -Meier (KM) estimates was used.
Secondary	Overall Survival (OS)	From the date of randomization until 62 months and 18 days	OS was defined as the time from the date of randomization until the date of death from any cause. Kaplan-Meier estimates was used.
Secondary	Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)	From the date of randomization until 62 months and 18 days	TTCD: time from randomization to first clinically meaning full deterioration (CMD) that was confirmed at next scheduled visit. EORTC-QLQ-C30 was a 30-item cancer-specific instrument consisting of 5 functional scales (physical,role,emotional,social \& cognitive), 9 symptom scales (fatigue, nausea/vomiting,general pain,dyspnea,insomnia,appetite loss,constipation,diarrhea,financial difficulties) \& global health status scale. Most items were scored 1(not at all) to 4(very much) except for items contributing to global health status/QoL, which were scored 1(very poor) to 7(excellent). All raw domain scores were linearly transformed to 0-100scale with higher scores on symptoms indicate worse health state. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of -13. This was derived from an Exit Survey conducted using Patient Global Impression of Severity/Change(PGIS/PGIC) questionnaires as an anchor for estimating meaningful change. KM estimates was used.
Secondary	Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25	From the date of randomization until 62 months and 18 days	TTCD: time from randomization to first CMD that was confirmed at next scheduled visit. EORTC QLQ-OG25 evaluated gastric and GEJ cancer specific symptoms. A 25 item instrument with 6 scales: dysphagia (3 items), eating restrictions (4 ), reflux (2), odynophagia (2), pain and discomfort (2), anxiety (2), as well as 10 single items: eating in front of others, dry mouth, trouble with taste, body image, trouble swallowing saliva, choked when swallowing, trouble with coughing, trouble talking, weight and hair loss. Items were scored:1: not at all; 2: a little, 3: quite a bit, 4: very much, and were transformed linearly into scores (0 to 100) with higher scores indicating worse symptoms. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of 16.67. This was derived from an Exit Survey conducted to use PGIS/PGIC questionnaires as an anchor for estimating the meaningful change. KM estimates was used.
Secondary	Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30	From the date of randomization until 62 months and 18 days	TTCD: time from randomization to first CMD that was confirmed at the next scheduled visit. The EORTC-QLQ-C30 was a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items were scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which were scored 1 ("very poor") to 7 ("excellent"). All raw domain scores were linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of -10. This was derived from an Exit Survey conducted to use PGIS/PGIC questionnaires as an anchor for estimating the meaningful change. KM estimates was used.
Secondary	Objective Response Rate (ORR)	From the date of randomization until 62 months and 18 days	ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as was assessed by IRC per RECIST 1.1. CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.
Secondary	Duration Of Response (DOR)	From date of first response (CR/PR) until 62 months and 18 day	DOR was defined as the time from the date of the first response (CR/PR) until the date of PD as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest.CR was defined as complete resolution of all attributable clinical symptoms and physical findings. PR was defined as partial resolution of at Least some of the clinical symptoms and physical findings.PD was defined as development of new, or progression of existing metastases to the primary cancer under the sudy.
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From first dose until 62 months and 18 days	An Adverse event (AE) is any untoward medical occurrence in a participant administered a study drug, and which does not have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or notconsidered related to the medicinal product. TEAE defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
Secondary	Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status	Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C39	ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead.
Secondary	Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire	Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up	The EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the global health status/QoL, which are scored 1 ("very poor") to 7 ("excellent"). All raw domain scores are linearly transformed to a 0-100 scale with higher scores on symptoms indicate a worse health state.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival (PFS)	From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)	FAS	Months	MEDIAN
SECONDARY	Overall Survival (OS)	From the date of randomization until 62 months and 18 days	FAS	Months	MEDIAN
SECONDARY	Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)	From the date of randomization until 62 months and 18 days	FAS	Months	MEDIAN
SECONDARY	Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25	From the date of randomization until 62 months and 18 days	FAS	Months	MEDIAN
SECONDARY	Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30	From the date of randomization until 62 months and 18 days	FAS	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR)	From the date of randomization until 62 months and 18 days	FAS	Percentage of participants	NUMBER
SECONDARY	Duration Of Response (DOR)	From date of first response (CR/PR) until 62 months and 18 day	FAS - All Objective Responders	Months	MEDIAN
SECONDARY	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	From first dose until 62 months and 18 days	Safety analysis set (SAF) included all participants who received at least 1 dose of any study drug (zolbetuximab/placebo and mFOLFOX6).	Participants	NUMBER
SECONDARY	Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status	Baseline, cycle (C) 1 day (D) 22, D1 and D22 of C2 through C39	FAS with available data was analyzed.	Participants	NUMBER
SECONDARY	Change From Baseline in Health Related Quality of Life (HRQoL) Measured by the EORTC-QLQ-C30 Questionnaire	Baseline, C1D22, D1 and D22 of C2 through C25, C26D1, C27D1,C28D1 30 day follow up, 90 day follow up	FAS with available data was analyzed.	units on Scale	MEAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group4,598

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression Free Survival (PFS)	mFOLFOX6 + Zolbetuximab	11.04	95% Confidence Interval 9.69 to 12.52	Months
Progression Free Survival (PFS)	mFOLFOX6+ Placebo	8.94	95% Confidence Interval 8.21 to 10.41	Months
Overall Survival (OS)	mFOLFOX6 + Zolbetuximab	18.23	95% Confidence Interval 16.13 to 20.63	Months
Overall Survival (OS)	mFOLFOX6+ Placebo	15.57	95% Confidence Interval 13.67 to 16.92	Months
Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)	mFOLFOX6 + Zolbetuximab	9.89	95% Confidence Interval 6.01 to NA	Months
Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)	mFOLFOX6+ Placebo	12.32	95% Confidence Interval 9.26 to NA	Months
Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25	mFOLFOX6 + Zolbetuximab	NA	95% Confidence Interval NA to NA	Months
Time to Confirmed Deterioration (TTCD) Using Oesophago-gastric Questionnaire (OG25) on Abdominal Pain and Discomfort as Measured by EORTC QLQ-OG25	mFOLFOX6+ Placebo	NA	95% Confidence Interval 15.67 to NA	Months
Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30	mFOLFOX6 + Zolbetuximab	15.44	95% Confidence Interval 7.06 to 23.89	Months
Time to Confirmed Deterioration (TTCD) Using Global Health Status as Measured by EORTC QLQ-C30	mFOLFOX6+ Placebo	11.83	95% Confidence Interval 9.23 to 15.08	Months

1 to 10 of 4,598Source ClinicalTrials.gov

See all 4,598 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	mFOLFOX6 + Zolbetuximab	283
Overall Study	STARTED	mFOLFOX6+ Placebo	282
Overall Study	Participants Who Received at Least One Dose of Study Drug	mFOLFOX6 + Zolbetuximab	279
Overall Study	Participants Who Received at Least One Dose of Study Drug	mFOLFOX6+ Placebo	278
Overall Study	COMPLETED	mFOLFOX6 + Zolbetuximab	26
Overall Study	COMPLETED	mFOLFOX6+ Placebo	17
Overall Study	NOT COMPLETED	mFOLFOX6 + Zolbetuximab	257
Overall Study	NOT COMPLETED	mFOLFOX6+ Placebo	265

Source ClinicalTrials.gov

Adverse events1,430

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Zolbetuximab	105	279	309
other	Anaemia	Blood and lymphatic system disorders	5-fluorouracil	211	557	616
other	Anaemia	Blood and lymphatic system disorders	Folinic Acid / Leucovorin	211	557	616
other	Anaemia	Blood and lymphatic system disorders	Oxaliplatin	211	557	616
other	Anaemia	Blood and lymphatic system disorders	Placebo	106	278	307
other	Leukopenia	Blood and lymphatic system disorders	Zolbetuximab	17	279	34
other	Leukopenia	Blood and lymphatic system disorders	5-fluorouracil	30	557	57
other	Leukopenia	Blood and lymphatic system disorders	Folinic Acid / Leucovorin	30	557	57
other	Leukopenia	Blood and lymphatic system disorders	Oxaliplatin	30	557	57
other	Leukopenia	Blood and lymphatic system disorders	Placebo	13	278	23

1 to 10 of 1,430Source ClinicalTrials.gov

See all 1,430 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zolbetuximab	197	283
Total, all-cause mortality	5-fluorouracil	414	565
Total, all-cause mortality	Folinic Acid / Leucovorin	414	565
Total, all-cause mortality	Oxaliplatin	414	565
Total, all-cause mortality	Placebo	217	282
Total, other adverse events	Zolbetuximab	276	279
Total, other adverse events	5-fluorouracil	550	557
Total, other adverse events	Folinic Acid / Leucovorin	550	557
Total, other adverse events	Oxaliplatin	550	557
Total, other adverse events	Placebo	274	278

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
37068504	DERIVED	PubMed
38861294	DERIVED	PubMed
40680855	DERIVED	PubMed
42095986	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
mFOLFOX6 + Zolbetuximab vs mFOLFOX6+ Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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