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Clinical trial

A Study of the Safety and Efficacy of QL1706 in Combination With Chemotherapy in First-Line Treatment of Patients With Stage IIIB/C and Stage IV Non-Small Cell Lung Cancer

ID
Name
QL1706-201
Description
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.
Trial arms
Trial start
2022-06-01
Estimated PCD
2024-01-01
Trial end
2024-01-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
QL1706
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.
Arms:
Treatment A, Treatment B
Size
100
Primary endpoint
Adverse events Adverse events Adverse events adverse events
Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-11-24

1 organization

1 product

1 indication

Organization
Qilu Pharmaceutical
Product
QL1706
Indication
Non-small-cell Lung Cancer