To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC
NCT ID:
NCT06610734
Condition:
Small Cell Lung Cancer Extensive Stage
Conditions: Official terms:
Small Cell Lung Carcinoma
Immune Checkpoint Inhibitors
Conditions: Keywords:
SCLC
Adebrelimab
LDRT
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab combined with chemotherapy synchronous LDRT
Arm group label:
Group A
Arm group label:
Group B
Other name:
immunotherapy
Other name:
Programmed death ligand 1 inhibitor
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Chemotherapy
Arm group label:
Group A
Arm group label:
Group B
Intervention type:
Radiation
Intervention name:
low dose radiotherapy
Description:
low dose radiotherapy
Arm group label:
Group A
Summary:
A multicenter, open-label, phase Ⅲ randomized controlled trial evaluating the efficacy
and safety of adebrelimab in combination with chemotherapy and low-dose radiotherapy
(LDRT) as first-line treatment for extensive-stage small cell lung cancer (SCLC)
Detailed description:
A multicenter, open-label, phase III randomized controlled trial evaluating the efficacy
andsafety of adbelizumab in combination with chemotherapy and low-dose radiotherapy
(LDRT) as a first-line treatment for extensive-stage small cell lung cancer (SCLC). At
least 202 participants will be enrolled in this study.
Criteria for eligibility:
Criteria:
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."
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Collaborator:
Agency:
Shanghai Shengdi Pharmaceutical Co., Ltd
Agency class:
Industry
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06610734
