Small Cell Lung Cancer Extensive Stage
Conditions
Keywords
SCLC, Adebrelimab, LDRT
Brief summary
Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
Detailed description
Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)
Interventions
DRUGAdebrelimab
Adebrelimab combined with chemotherapy synchronous LDRT
DRUGChemotherapy
Chemotherapy
RADIATIONlow dose radiotherapy
low dose radiotherapy
Sponsors
Sichuan University
Shanghai Shengdi Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants aged 18 to 75 years, regardless of gender; * ECOG Performance Status (PS) score of 0-1; * Expected survival duration of no less than 8 weeks; * Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system); * Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.
Exclusion criteria
* Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer; * Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator); * Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study; * Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents; * History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy; * Any previous T-cell co-stimulation or immune checkpoint therapies administered; * Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\"
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | From date of randomization to the time when the subject died from any cause, up to approximately 36 months | Time from randomization to death from any cause. Unit of measure: median overall survival (months); hazard ratio (HR) and 95% confidence interval (CI); 12- and 24-month survival rates (%). Assessment schedule: survival status assessed every 3 months after the end of treatment until death or study cut-off (up to 36 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months. | Time from randomization to the earliest of radiologically documented progressive disease (per RECIST 1.1 assessed by the investigator) or death from any cause. Unit of measure: median progression-free survival (months); hazard ratio (HR) and 95% confidence interval (CI); 6- and 12-month PFS rate (%). Measurement tool: contrast-enhanced CT or MRI scanned every 6 weeks for the first 48 weeks, then every 12 weeks until disease progression, death, or study cut-off. |
| Time to second progression or death (PFS2) | From date of randomization to the date of second documented progression or death from any cause, whichever occurs first, assessed up to 36 months | Defined as time from randomization to the earliest of radiologically documented second progression (per RECIST 1.1 assessed by the investigator ) or death from any cause. Unit of measure: median PFS2 (months); hazard ratio (HR) and 95% CI; 6- and 12-month PFS2 rate (%). Measurement tool: contrast-enhanced CT/MRI. Assessment schedule: imaging every 6 weeks during induction; every 4-6 weeks during maintenance; after first PD, every 6 weeks until second PD or death. |
| Disease control rate | From date of randomization until disease progression, death, or 24 months, whichever occurs first. | Proportion of randomized subjects with best overall response of complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 assessed by the investigator. Unit of measure: percentage of patients (%); 95% confidence interval (Clopper-Pearson). Assessment schedule: scans every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months. |
| Overall response rate (ORR) | From date of randomization until disease progression, death, or 24 months, whichever occurs first | Proportion of randomized subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 assessed by the investigator. Unit of measure: percentage of patients (%); 95% confidence interval (Clopper-Pearson). Assessment schedule: scans every 6 weeks (±7 days) for the first 48 weeks, then every 12 weeks (±7 days) until progression, death, or 36 months; response determined by site investigator. |
| Duration of response (DoR) | From the date of first CR/PR to the date of documented progression or death from any cause, assessed up to 36 months | Time from first documented complete response (CR) or partial response (PR) per RECIST 1.1 (investigator assessment) until the date of documented progressive disease or death from any cause, whichever occurs first. Unit of measure: median duration of response (months); 95% confidence interval of the median; 6- and 12-month response duration rate (%) Assessment schedule: imaging every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months. |
| Depth of Response | From date of randomization until disease progression, death, or 24 months, whichever occurs first. | Maximum percentage reduction in the sum of longest diameters of target lesions relative to baseline per RECIST 1.1 assessed by the investigator. Unit of measure: median percentage change (%); inter-quartile range (IQR); Assessment schedule: scans every 6 weeks for the first 48 weeks, then every 12 weeks until progression, death, or 36 months; tumor diameters measured by the site investigator. |
| Post-progression survival (PPS) | From the date of documented progression to the date of death from any cause, assessed up to 36 months after progression. | Time from the date of first documented progressive disease (per RECIST 1.1, investigator assessment) to the date of death from any cause. Unit of measure: median post-progression survival (months); hazard ratio (HR) and 95% confidence interval; 6- and 12-month survival rate (%). Assessment schedule: survival status contacted every 3 months after progression until death, lost to follow-up, or study cut-off. |
| Incidence and severity of adverse events (AEs) | Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases (to 90 days after the last dose of drug). | Number and percentage of participants experiencing AEs graded per CTCAE v5.0 by the treating investigator. Unit of measure: incidence rate (%); number of events; severity distribution (Grade 1-5). Measurement tool: investigator assessment using CTCAE v5.0. Assessment schedule: continuous monitoring from informed consent through 90 days after last dose of study drug; assessed at every study visit (baseline, weekly during cycle 1, then day 1 of each subsequent cycle, and at follow-up). |
| Incidence of serious adverse events (SAEs) | Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases(before 2nd PD and 3 month afterwords). | Number and percentage of participants experiencing serious adverse events (SAE) graded per CTCAE v5.0 by the treating investigator. Unit of measure: incidence rate (%) of subjects with ≥1 SAE; number of events; severity distribution (Grade 1-5). Measurement tool: investigator assessment using CTCAE v5.0. Assessment schedule: continuous monitoring from informed consent through 90 days after last dose of study drug. All SAEs reported within 24h of awareness. |
Countries
China
Contacts
CONTACTYou Lu
CONTACTZhuoran Yao, M.D.
PRINCIPAL_INVESTIGATORYou Lu
West China Hospital
Outcome results
None listed