Clinical Study of QL1706 Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment A Participants with squamous cell carcinoma will receive QL1706, paclitaxel and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706 until unacceptable toxicity or loss of clinical benefit. |
Drug: 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.
|
| Experimental: Treatment B Participants with non-squamous cell carcinoma will receive QL1706, bevacizumab, pemetrexed, and carboplatin by intravenous (IV) injection on Day 1 of each 21-day cycle for 4 cycles in the induction treatment. In the maintenance phase, participants will be treated with QL1706, bevacizumab and pemetrexed until unacceptable toxicity or loss of clinical benefit. |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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)]
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Qilu Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- QL1706-201