Back to resultsSafety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer
Primary Purpose
Extensive-stage Small-cell Lung Cancer
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
QL1706
Carboplatin
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Extensive-stage Small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects participate voluntarily and sign informed consent.
- Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end organ function
Exclusion Criteria:
- Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
- Active, known or suspected autoimmune disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, radiation pneumonia requiring steroid treatment or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Significant cardiovascular disease
Sites / Locations
- Zhejiang Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QL1706+chemotherapy
Arm Description
Participants received intravenous infusions of QL1706 5mg/kg in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle for 4-6 cycles. On Days 2 and 3 of every 21-day cycle, etoposide 100 mg/m^2 was administered alone for 4-6 cycles. Thereafter, participants received maintenance QL1706 5mg/kg on Day 1 of every 21-day cycle until progressive disease, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Outcomes
Primary Outcome Measures
Number of Participants Who Experienced At Least One Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented.
Secondary Outcome Measures
Percentage of Participants With Objective Response (OR)
The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1
Duration of Response (DOR)
The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1
Duration of Progression-Free Survival (PFS)
The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1
Duration of Overall Survival (OS)
Baseline until death from any cause
Full Information
NCT ID
NCT05309629
First Posted
March 25, 2022
Last Updated
May 16, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05309629
Brief Title
Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer
Official Title
An Open-label Phase 2 Study of QL1706 Plus Carboplatin and Etoposide as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
November 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open label, phase 2 clinical study to evaluate the safety, tolerability, efficacy, pharmacokinetic (PK) profile, and immunogenicity of QL1706 plus carboplatin and etoposide as first-line therapy in patients with extensive-stage small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-stage 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
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QL1706+chemotherapy
Arm Type
Experimental
Arm Description
Participants received intravenous infusions of QL1706 5mg/kg in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 mg/mL/min followed by etoposide 100 mg/m^2 on Day 1 of every 21-day cycle for 4-6 cycles. On Days 2 and 3 of every 21-day cycle, etoposide 100 mg/m^2 was administered alone for 4-6 cycles. Thereafter, participants received maintenance QL1706 5mg/kg on Day 1 of every 21-day cycle until progressive disease, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
Intervention Type
Drug
Intervention Name(s)
QL1706
Intervention Description
Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle for 4-6 cycles.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle for 4-6 cycles.
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced At Least One Adverse Event (AE)
Description
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of all participants who experienced at least one AE is presented.
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response (OR)
Description
The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1
Time Frame
Up to approximately 2 years
Title
Duration of Response (DOR)
Description
The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1
Time Frame
Up to approximately 2 years
Title
Duration of Progression-Free Survival (PFS)
Description
The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1
Time Frame
Up to approximately 2 years
Title
Duration of Overall Survival (OS)
Description
Baseline until death from any cause
Time Frame
Up to approximately 2 years and a half
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects participate voluntarily and sign informed consent.
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
No prior systemic treatment for ES-SCLC
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease, as defined by RECIST v1.1
Adequate hematologic and end organ function
Exclusion Criteria:
Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
Active, known or suspected autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, radiation pneumonia requiring steroid treatment or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
Positive test result for human immunodeficiency virus (HIV)
Active hepatitis B or hepatitis C
Significant cardiovascular disease
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of First-line Treatment With QL1706 Plus Chemotherapy in Extensive-Stage Small Cell Lung Cancer
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