QL1203 In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy and Safety

NCT ID: NCT04233151

Last Updated: 2023-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 590 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2025-07-30

Brief Summary

The purpose of this study is to determine the treatment effect of QL1203 in combination with mFOLFOX6 compared to Placebo in combination with mFOLFOX6 as first line therapy for metastatic colorectal cancer.

Detailed Description

The study is a randomized, double-blind, Placebo-controlled, multi-center Phase III study. It is planned to enroll 590 patients with previously untreated wild-type RAS metastatic colorectal cancer. Subjects are randomized into the QL1203 combined with Oxaliplatin/5-fluorouracil/ Leucovorin or Placebo combined with Oxaliplatin/5-fluorouracil/ Leucovorin treatment group by a ratio of 2:1.

Conditions

Metastatic Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mFOLFOX6 + QL1203

Participants receive QL1203, 6mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity

Group Type: EXPERIMENTAL

QL1203

Intervention Type: DRUG

6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

mFOLFOX6 regimen

Intervention Type: DRUG

The mFOLFOX6 regimen is consist of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1;leucovorin, 200 mg/m\^2 on Days 1 and 5-fluorouracil 400 mg/m\^2 IV bolus on day 1, then 1200 mg/m\^2/dx2days(total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion. Each cycle was 14 days.

mFOLFOX6 + Placebo

Participants received Placebo，6 mg/kg on Day 1 and mFOLFOX6 chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

mFOLFOX6 regimen

Intervention Type: DRUG

The mFOLFOX6 regimen is consist of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1;leucovorin, 200 mg/m\^2 on Days 1 and 5-fluorouracil 400 mg/m\^2 IV bolus on day 1, then 1200 mg/m\^2/dx2days(total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion. Each cycle was 14 days.

Interventions

QL1203

6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

Intervention Type: DRUG

Placebo

6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.

Intervention Type: DRUG

mFOLFOX6 regimen

The mFOLFOX6 regimen is consist of oxaliplatin 85 mg/m\^2 intravenous (IV) infusion on Day 1;leucovorin, 200 mg/m\^2 on Days 1 and 5-fluorouracil 400 mg/m\^2 IV bolus on day 1, then 1200 mg/m\^2/dx2days(total 2400 mg/m\^2 over 46-48 hours) IV continuous infusion. Each cycle was 14 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosed as metastatic colorectal adenocarcinoma and is not suitable for local treatment such as radical resection, radiotherapy, radiofrequency and so on.
• Man or woman at least 18 years old.
• At least one measurable lesion can be evaluated according to Response Evaluation Criteria In Solid Tumors 1.1（RECIST1.1） criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status should be 0-1 before randomization.
• The level of organ function must meet the requirements before randomization.
• Prior to randomization, the damage caused by other treatments had recovered to < grade 2 (CTCAE version 4.03).

Exclusion Criteria

• Prior systemic or local chemotherapy for colorectal cancer，except in the following cases: the interval between the last dose of neoadjuvant or adjuvant therapy and recurrence> 6 months。
• Prior epithelial growth factor receptor(EGFR)-targeted drugs for colorectal cancer.
• Presence of central nervous system (CNS) metastases before the informed consent was signed, except for those who had stabilized CNS metastases for more than 4 weeks and had no symptoms after treatment.
• History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment.
• History of interstitial lung disease.
• Existing intestinal obstruction before randomization, active inflammatory bowel disease.
• Patients with non-healing abdominal fistula and gastrointestinal perforation before randomization.
• There were severe active infections or uncontrollable infections that required systemic treatment and could not be enrolled at the decision of the investigator within 14 days before randomization.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin Shen, Professor

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Weijian Guo, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyan Kang, CMO

Role: CONTACT

Xiaoyan.Kang@qilu-pharma.com

0531-83129659

Facility Contacts

Lin Shen, Professor

Role: primary

Weijian Guo, Professor

Role: primary

Other Identifiers

QL1203-003

Identifier Type: -

Identifier Source: org_study_id