Phase Ib/II, open-label, multicentre study to evaluate the efficacy and safety of low-dose radiotherapy (LDRT) combined with AK104 and chemotherapy as first-line treatment for patients with ES-SCLC.
This trial aims to assess the safety and efficacy of a new therapeutic strategy that combines to low-dose radiotherapy combination With AK104 plus etoposide and carboplatin/cisplatin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
IV infusion
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
China West Hospital
Chengdu, Sichuan, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGIncidence of treatment-related adverse events
The incidence of treatment-related adverse events were measured for determining tolerability and safety. Adverse events (AEs) are evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0). Events of grade 3-5 are defined as moderate and severe adverse events.
Time frame: 48 months
Progression free survival at 6 months (PFS-6)
PFS-6 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving progression-free status at 6 months from diagnosis.
Time frame: 6 months
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST V1.1
Time frame: Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years
Progression free survival (PFS)
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first)
Time frame: Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months.
PFS Rates at 12 months (PFS-12)
PFS-6 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients achieving progression-free status at 12 months from diagnosis.
Time frame: 12 months.
Overall survival (OS)
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The subjects will receive LDRT, from C1D1-C1D5, once a day for 3Gy, until the target dose of 15Gy is achieved (Cycles 1). LDRT treatment for primary/mediastinal positive lymph nodes/metastatic lesions during maintenance therapy (C1D1-C1D5, 15Gy).
OS is defined as the time from randomization to death.
Time frame: Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months.
OS Rates at 12 Months (OS-12)
OS-12 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients survival at 12 months from diagnosis.
Time frame: 12 months
OS Rates at 24 Months ( OS-24)
OS-24 is defined as patient outcomes were evaluated at diagnosis and in the subsets of patients survival at 24 months from diagnosis.
Time frame: 24 months
Objective Response Rate (ORR)
ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders.
Time frame: Interval between the date of enrollment and the date of death from any cause, up to a maximum of 18 months.
Number of participants with adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product. temporally associated with the use of study treatment, whether or not considered related to the study treatment
Time frame: From the subject signs the Informed Consent Form to 90 days after the last dose of study treatment or initiation of other anti-tumor therapy