Phase 1b/2 Study of LDRT in Combination With AK104 Plus Chemotherapy as First-line Treatment for ES-SCLC
NCT Number: NCT06477523
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: SCLC, Extensive Stage
Interventions: DRUG: AK104|DRUG: Etoposide|DRUG: Carboplatin|RADIATION: low-dose radiotherapy
Sponsor: Sichuan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 57
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-16
Completion Date: 2026-12
Locations: China West Hospital, Chengdu, Sichuan, 610000, China|West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China

Summary:
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.

Primary Outcome Measures: Incidence 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., 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., 6 months
Secondary Outcome Measures: 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, 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), 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., 12 months.|Overall survival (OS), OS is defined as the time from randomization to death., 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., 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., 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., 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, 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