CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 520 enrolled
Drug / intervention
CMAB009 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03206151
NCT03206151Phase 3Completed

Open, Randomized, Controlled, Multicenter Phase III Study Comparing CMAB009 Plus FOLFIRI Versus FOLFIRI Alone as First-line Treatment for Epidermal Growth Factor Receptor-expressing, RAS/BRAF Wild-type, Metastatic Colorectal Cancer

Taizhou Mabtech Pharmaceutical Co.,Ltd·interventional·Posted Jul 2, 2017·Updated May 23, 2025

In Brief

A Phase 3 clinical trial evaluating CMAB009, Irinotecan, and 2 other interventions for Metastatic Colorectal Cancer. Completed, enrolled 520 participants across 2 sites.

Detailed Summary

Drugs used against cancer work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as CMAB009, can block tumor growth in different ways. Giving combination chemotherapy together with CMAB009 as first treatment after diagnosis of a metastatic colorectal cancer(first-line treatment)may improve the treatment efficacy. However, it is not yet known whether giving combination chemotherapy together with CMAB009 is more effective than combination chemotherapy alone. This open-label trial investigates the effectiveness of CMAB009 in combination with a standard and effective chemotherapy FOLFIRI(5-Fluorouracil /Folinic acid plus Irinotecan)for RAS/BRAF wild-type, metastatic colorectal cancer in first-line setting, compared to the same chemotherapy alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJul 2, 2017
Enrollment StartDec 12, 2017
Primary CompletionMay 6, 2022
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9 years ago

Interventions

CMAB009drug

for injection only

Irinotecandrug

for injection only

Folinic aciddrug

for injection only

5-fluorouracildrug

for injection only