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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-23

Study Completion Date

2028-12-31

Brief Summary

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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)

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Detailed Description

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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)

Conditions

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Small Cell Lung Cancer Extensive Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Adebrelimab combined with chemotherapy synchronous LDRT

Group Type EXPERIMENTAL

Adebrelimab

Intervention Type DRUG

Adebrelimab combined with chemotherapy synchronous LDRT

Chemotherapy

Intervention Type DRUG

Chemotherapy

low dose radiotherapy

Intervention Type RADIATION

low dose radiotherapy

Group B

Adebrelimab combined with chemotherapy

Group Type ACTIVE_COMPARATOR

Adebrelimab

Intervention Type DRUG

Adebrelimab combined with chemotherapy synchronous LDRT

Chemotherapy

Intervention Type DRUG

Chemotherapy

Interventions

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Adebrelimab

Adebrelimab combined with chemotherapy synchronous LDRT

Intervention Type DRUG

Chemotherapy

Intervention Type DRUG

low dose radiotherapy

Intervention Type RADIATION

Other Intervention Names

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immunotherapy Programmed death ligand 1 inhibitor

Eligibility Criteria

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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;#34;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No