Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer

A Randomized, Open-label, Japan-Korea-Taiwan Collaborative Phase 3 Study to Compare the Efficacy of Nimotuzumab and Irinotecan Combination Therapy Versus Irinotecan Monotherapy as Second Line Treatment in Subjects With Advanced or Recurrent Gastric and Gastroesophageal Junction Cancer

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01813253

Enrollment

400

Registered

2013-03-18

Start date

2013-05-13

Completion date

2018-02-19

Last updated

2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Keywords

epidermal growth factor receptor, second line

Brief summary

This study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer.

Detailed description

This randomized, open-label, Japan, Korea and Taiwan collaborative, phase 3 study will evaluate overall survival of nimotuzumab in combination with irinotecan compared to irinotecan alone in subjects with EGFR overexpressed advanced gastric or gastroesophageal junction cancer. Approximately 400 subjects will be randomized in a 1:1 ratio to receive irinotecan (control group) or nimotuzumab and irinotecan (combination group). Nimotuzumab and/or irinotecan should be continued until disease progression or intolerable toxicity. Nimotuzumab is administered at 400 mg once weekly as an intravenous infusion and irinotecan is administered at 150 mg/m2 once every 2 weeks as an intravenous infusion.

Interventions

DRUGIrinotecan

150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops

DRUGNimotuzumab

400mg IV once weekly until progression or unacceptable toxicity develops

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Advanced or recurrent subjects with gastric or gastroesophageal junction adenocarcinoma. 2. Subjects who experienced disease progression during first line or within 6 months after the last dose of first line therapy. The first line regimen must have contained a 5-fluorouracil based agent and platinum agent. 3. Subjects with EGFR overexpression (2+ or 3+ in IHC)

Exclusion criteria

1. Subjects who have received irinotecan 2. Subjects who have received EGFR-directed therapy 3. Other active malignancy within the last 5 years

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	Around 4.5 years after first subject randomization	Overall survival is defined as the time from the date of randomization to the date of the death from any cause.

Secondary

Measure	Time frame	Description
Progression Free Survival	Around 4.5 years after first subject randomization	Progression Free Survival is defined as the time from the date of randomization to the date of progression or death from any cause, whichever comes first.
Overall Response Rate	Around 4.5 years after first subject randomization	Overall Response Rate is defined as the proportion of subjects with CR or PR in the best overall response.
Disease Control Rate	Around 4.5 years after first subject randomization	Disease Control Rate is defined as the proportion of subjects with CR, PR or SD in the best overall response.
Incidence of adverse events	Around 4.5 years after first subject randomization	Incidence of adverse events using latest CTCAE version 4 including minor version

Countries

Japan, South Korea, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026