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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Intravenous infusions of QL1706 5mg/kg on Day 1 of every 21-day cycle.
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.
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.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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.
Time frame: Up to approximately 2 years
Percentage of Participants With Objective Response (OR)
The efficacy outcome of objective response rate (ORR) as assessed by the investigator using RECIST v1.1
Time frame: Up to approximately 2 years
Duration of Response (DOR)
The efficacy outcome of DOR as assessed by the investigator using RECIST v1.1
Time frame: Up to approximately 2 years
Duration of Progression-Free Survival (PFS)
The efficacy outcome of PFS as assessed by the investigator using RECIST v1.1
Time frame: Up to approximately 2 years
Duration of Overall Survival (OS)
Baseline until death from any cause
Time frame: Up to approximately 2 years and a half
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