Clinical Study of QL1706 Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer
April 7, 2022 updated by: Qilu Pharmaceutical Co., Ltd.
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
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
Informed consent until disease progression or death, which ever occurs first (up to approximately 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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)
|
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)
|
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)
|
First administration until disease progression or death, which ever occurs first (up to approximately 24 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2022
Primary Completion (Anticipated)
January 1, 2023
Study Completion (Anticipated)
January 1, 2024
Study Registration Dates
First Submitted
April 7, 2022
First Submitted That Met QC Criteria
April 7, 2022
First Posted (Actual)
April 14, 2022
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QL1706-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.