Clinical trial NCT06610734: Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC
Official title: A Multicenter, Open-label, Phase Ⅲ Randomized Controlled Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Small Cell Lung Cancer Extensive Stage
Keywords: SCLC
Adebrelimab
LDRT
Lead sponsor: Sichuan University
Sponsor class: OTHER
Collaborators: name: Shanghai Shengdi Pharmaceutical Co., Ltd
First posted: 2024-09-24
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.\&amp;amp;#34;

Primary outcomes:
measure: Progression free survival
timeFrame: Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months
Secondary outcomes:
measure: overall survival
timeFrame: From date of randomization to the time when the subject died from any cause, up to approximately 24 months
measure: Disease control rate
timeFrame: Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months
measure: overall response rate
timeFrame: Every 6 weeks (±7 days) from the first dose of study drug, and every 12 weeks (±7 days) after 48 weeks, up to approximately 24 months
measure: Duration of response
timeFrame: Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months
measure: Post-progression survival
timeFrame: From date of progression to the time when the subject died from any cause, up to approximately 24 months
measure: adverse events
timeFrame: Baseline up to approximately 36 months
measure: Serious adverse events
timeFrame: Baseline up to approximately 36 months
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital
name: You Lu
role: PRINCIPAL_INVESTIGATOR
References: