Extensive-stage Small-cell Lung Cancer
Conditions
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.
Interventions
DRUGQL1706
Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle.
DRUGCarboplatin
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.
DRUGEtoposide
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.
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects participate voluntarily and sign informed consent. 2. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system) 3. No prior systemic treatment for ES-SCLC 4. Eastern Cooperative Oncology Group performance status of 0 or 1 5. Measurable disease, as defined by RECIST v1.1 6. Adequate hematologic and end organ function
Exclusion criteria
1. Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation 2. Active, known or suspected autoimmune disease 3. 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. 4. Positive test result for human immunodeficiency virus (HIV) 5. Active hepatitis B or hepatitis C 6. Significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced At Least One Adverse Event (AE) | Up to approximately 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | Up to approximately 2 years | The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1 |
| Duration of Response (DOR) | Up to approximately 2 years | The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1 |
| Duration of Progression-Free Survival (PFS) | Up to approximately 2 years | The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1 |
| Duration of Overall Survival (OS) | Up to approximately 2 years and a half | Baseline until death from any cause |
Countries
China
Outcome results
None listed