Back to resultsClinical Study of QL1706 Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer
Primary Purpose
Non-small-cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
QL1706
Sponsored by
About this trial
This is an interventional treatment trial for Non-small-cell Lung Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment A
Treatment B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Adverse events Adverse events Adverse events adverse events
Secondary Outcome Measures
Progression Free Survival (PFS) in the intent to treat (ITT) population, as determined by the investigator
Objective Response Rate (ORR) in the ITT population
Duration of response (DOR) in the ITT population
Overall Survival (OS) in the ITT population
Full Information
NCT ID
NCT05329025
First Posted
April 7, 2022
Last Updated
April 7, 2022
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05329025
Brief Title
Clinical Study of QL1706 Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer
Official Title
Clinical 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small-cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
QL1706
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of QL1706 Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer
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