A Study of QL1706 Combined With Chemotherapy in Advanced Non-small Cell Lung Cancer

Qilu Pharmaceutical Co., Ltd.100 enrolled

Overview

This study will evaluate the efficacy and safety of QL1706 when given in combination with bevacizumab, paclitaxel or pemetrexed, and carboplatin in patients with Stage IIIB/C and Stage IV Non-Small Cell Lung Cancer (NSCLC). The study will be conducted in two phases: Induction Phase and Maintenance Phase.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Non-small-cell Lung Cancer

Interventions

QL1706DRUG

QL1706 will be administered by IV infusion at 5mg/kg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically or cytologically confirmed Stage IIIB/C or IV non-squamous NSCLC Measurable disease, as defined by RECIST v1.1 Eastern Cooperative Oncology Group Performance Status of 0 or 1 Life expectancy \>=3 months Adequate hematologic and organ function Exclusion Criteria: * History of leptomeningeal disease Uncontrolled tumor-related pain Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Uncontrolled or symptomatic hypercalcemia Active or history of autoimmune disease or immune deficiency History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Adverse events Adverse events Adverse events adverse events

Time frame: Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)

Secondary Outcomes

Progression Free Survival (PFS) in the intent to treat (ITT) population, as determined by the investigator

Time frame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

Objective Response Rate (ORR) in the ITT population

Time frame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

Duration of response (DOR) in the ITT population

Time frame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

Overall Survival (OS) in the ITT population

Time frame: First administration until disease progression or death, which ever occurs first (up to approximately 24 months)

Data from ClinicalTrials.gov

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