Exploratory Clinical Study of Adebrelimab Combined with Chemotherapy and Concurrent Radiotherapy Versus Sequential Radiotherapy As First-Line Treatment for Extensive-Stage Small Cell Lung Cancer（ES-SCLC）.

Peking University Cancer Hospital & Institute1 site in 1 country60 target enrollmentFebruary 2025

ConditionsSCLC, Extensive Stage Immunotherapy Chemotherapy Radiotherapy

InterventionsFirst-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC

DrugsFirst-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC

Overview

Phase: Phase 2
Intervention: First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC
Conditions: SCLC, Extensive Stage
Sponsor: Peking University Cancer Hospital & Institute
Enrollment: 60
Locations: 1
Primary Endpoint: PFS
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Immunotherapy combined with chemotherapy has emerged as the standard of care for patients with extensive-stage small cell lung cancer (ES-SCLC). The incorporation of thoracic radiotherapy can enhance treatment efficacy. Currently, the main types of research investigating immunotherapy combined with thoracic radiotherapy for untreated ES-SCLC are concurrent radiotherapy and sequential radiotherapy. The aim of this study is to evaluate the efficacy of adebelizumab in combination with chemotherapy, when administered concurrently with radiotherapy versus sequentially with radiotherapy, as a first-line treatment for ES-SCLC.

Registry

clinicaltrials.gov

Start Date

February 2025

End Date

January 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University Cancer Hospital & Institute

Responsible Party

Principal Investigator

Rong Yu, MD

Investigator Official Title

Peking University Cancer Hospital & Institute

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years, no gender restrictions;
•Confirmed pathological diagnosis of extensive-stage small cell lung cancer (ES-SCLC), defined as disease extending beyond one hemithorax, including malignant pleural and pericardial effusions or hematogenous metastases (according to the Veterans Administration Lung Cancer Study Group, VALG staging); stage IV (any T, any N, M1a/b/c) according to the AJCC (8th edition), or T3-4 due to multiple pulmonary nodules or tumor/nodule size too large to be included in a tolerable radiation therapy plan;
•Participants have not received systemic treatment for extensive-stage SCLC;
•No more than 5 lesions (including metastatic foci), with at least one measurable lesion (according to RECIST v1.1);
•ECOG performance status score of 0-2;
•Life expectancy ≥3 months;
•Consented and signed the informed consent form, willing and able to comply with planned visits, study treatments, laboratory tests, and other trial procedures;
•Normal major organ function, meeting the following criteria (without symptomatic treatment within 14 days): a) Hematology:
•Hemoglobin (Hb) ≥90g/L; Platelet (PLT) ≥100×10\^9/L; Neutrophil count (ANC) ≥1.5×10\^9/L; White blood cell count (WBC) ≥3.0×10\^9/L;
•Lymphocyte ≥0.5×10\^9/L; b) Biochemistry:

Exclusion Criteria

•Participants who have previously received any T-cell co-stimulation or immune checkpoint therapy, including but not limited to cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, CD137 agonists, or other T-cell targeted drugs.
•Participants who have previously received chemoradiotherapy for limited-stage SCLC;
•Participants with clinically symptomatic central nervous system metastases (such as brain, spinal cord), or leptomeningeal metastases; participants with active or new CNS metastases found on imaging during the screening period are not included. (Asymptomatic untreated CNS metastases with a lesion size \<1cm are allowed to be included);
•Participants with multiple liver metastases (isolated liver metastasis participants with metastasis \<2cm can be included)
•Participants with spinal cord compression;
•Participants with active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose, or with a history of autoimmune diseases and expected recurrence. Replacement therapies (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment;
•Diagnosed with immune deficiency or receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy within 14 days before the first dose; the use of physiological doses of glucocorticoids (≤10 mg/day of prednisone or equivalent) is allowed;
•Participants who have had arterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;
•Participants with a history of idiopathic pulmonary fibrosis, organizing pneumonia (such as cryptogenic organizing pneumonia), drug-induced pneumonia, or idiopathic pneumonia, or evidence of active pneumonia on chest computed tomography (CT) at screening (participants with active tuberculosis are not included);
•Participants who have undergone major surgical treatment or significant traumatic injury within 28 days before the first dose;

Arms & Interventions

experimental group

After three cycles of induction therapy with atezolizumab combined with carboplatin/cisplatin plus etoposide, patients who do not show progression will undergo immune-concurrent chemoradiotherapy and immune-sequential chemoradiotherapy, followed by maintenance therapy with atezolizumab until disease progression.

Intervention: First-line Immunotherapy Combined with Chemoradiotherapy for ES-SCLC

Outcomes

Primary Outcomes

PFS

Time Frame: From enrollment to the end of treatment at 1 year

From the date of enrollment to the date of disease progression

Secondary Outcomes

OS(From date of enrollment to maximum of 2 years or death)
Treatment-related adverse events(Duration of treatment and follow up until death or 90 days after enrollment)