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

Qilu Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: mFOLFOX6 regimen; Drug: Placebo; Drug: QL1203

Study type: Interventional

Funder types: Industry

Identifiers

NCT04233151

QL1203-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 590 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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590 participants in 2 patient groups

mFOLFOX6 + QL1203

Experimental group

Description:

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

Treatment:

Drug: mFOLFOX6 regimen

Drug: QL1203

mFOLFOX6 + Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: mFOLFOX6 regimen

Drug: Placebo