Non-small-cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGQL1706
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.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events Adverse events Adverse events adverse events | Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) in the intent to treat (ITT) population, as determined by the investigator | First administration until disease progression or death, which ever occurs first (up to approximately 24 months) |
| Objective Response Rate (ORR) in the ITT population | First administration until disease progression or death, which ever occurs first (up to approximately 24 months) |
| Duration of response (DOR) in the ITT population | First administration until disease progression or death, which ever occurs first (up to approximately 24 months) |
| Overall Survival (OS) in the ITT population | First administration until disease progression or death, which ever occurs first (up to approximately 24 months) |
Countries
China
Outcome results
None listed