The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer

Официальное название

Comparing the Efficiency Between Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer: a Randomized, Controlled, Open-label, Single-center Phase III Clinical Trial

Обзор

To compare the efficiency between surgery and radiotherapy after SHR-1316 (Adebrelimab)and platinum-containing doublet induction therapy for limited-stage small cell lung cancer

Подробное описание

1.1 Main purpose To compare the efficiency between surgery and radiotherapy after therapy with SHR-1316 and chemotherapy for limited-stage small cell lung cancer according to progression-free survival (PFS) 1.2 Secondary Purpose The incidence of adverse events (AEs) during treatment was assessed to identify the safety of SHR-1316 and chemotherapy combined with surgery or radiotherapy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

To evaluate the pathological response rate (MPR and PCR) of the surgical population after neoadjuvant therapy with SHR-1316 and chemotherapy for operable LD-SCLC according to the evaluation criteria of pathological response after neoadjuvant therapy recommended by the International Association for the Study of Lung Cancer (IASLC); To evaluate the overall survival (OS) of patients with limited-stage small cell lung cancer after therapy with SHR-1316 and chemotherapy combined with surgery or radiotherapy To evaluate the recurrence-free survival (RFS) in patients with limited-stage small cell lung cancer who received neoadjuvant SHR-1316 and chemotherapy combined with surgery; To evaluate the duration of response (DOR) in patients with limited-stage small cell lung cancer after SHR-1316 and chemotherapy combined with surgery or radiotherapy according to RECIST v1.1 To identify the impact on the health-related quality of life (HRQoL), mood, symptoms, sleep, etc. of patients undergoing surgery and radiotherapy after therapy with SHR-1316 and chemotherapy according to the Pulmonary Hospital Psychological Assessment Scale; 1.3 Exploratory Purpose To explore potential predictive biomarkers in archived and/or fresh tumor tissue and/or blood (or blood derivatives), including but not limited to programmed cell death protein ligand 1 (PD-L1) expression as determined by immunohistochemistry (IHC), gene expression profile (GEP), tumor mutational burden (TMB), tumor-infiltrating immune cell changes, etc., to evaluate the association of these markers with the study of treatment response or resistance mechanisms.

Вмешательства

• Комбинированный продукт chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy
  Induction treatment stage: SHR-1316(Adebrelimab)，20mg/kg,+Cisplatin 75mg/m2, d1+ etoposide 100mg/m2, d1,d2,d3, q3w, iv, 4 cycles. Patients who are able to receive surgery after assessed by two surgons would receive surgery or radiotherapy randomly. Adjuvant/ maintenance treatment stage: SHR-1316，20mg/kg, iv, q3w,up to 1 year

Первичные конечные точки

• progression-free survival [Срок оценки: 2 years]

Вторичные конечные точки (6)

• incidence of adverse events [Срок оценки: through study completion, an average of 1.5 years]
• pathological response [Срок оценки: up to 5 months]
• objective response rate [Срок оценки: through study completion, an average of 1.5 years]
• overall survival [Срок оценки: up to 60 months]
• recurrence free survival [Срок оценки: up to 60 months]
• the duration of response(DOR) [Срок оценки: up to 60 months]

Критерии участия

Критерии включения

• after signing informed consent;
• Aged 18-70;
• Histologically or cytologically confirmed SCLC, imaging examination and other confirmed limited-stage small cell lung cancer, and without previous treatment;
• For clinical stage IIB-III, all patients should have clear lymph node pathology by EBUS to exclud occult lymph node metastasis.
• Two thoracic surgeons assessed thar it would be able to achieve radical surgery or R0 resection after 4 cycles of treatment. Surgical approaches include lobectomy, sleeve resection and pneumonectomy
• ECOG performance status score 0-1 points;
• With a life expectancy of at least 12 weeks;
• At least one measurable tumor
• With normal Other major organs (liver, kidney, blood system, etc.) function:

Absolute neutrophil count (ANC) ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥90 g/L. Note: Patients should not receive blood transfusion or growth factor support within ≤ 14 days before blood collection during the screening period;

\- International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; Serum total bilirubin ≤ 1.5×ULN (total bilirubin in patients with Gilbert syndrome must be <3×ULN); Aspartate and alanine aminotransferase (AST and ALT) ≤2.5×ULN, or AST and ALT ≤5×ULN in patients with liver metastases

• Female patients of childbearing potential must voluntarily use highly effective contraception during the study period until ≥ 120 days after the last dose of chemotherapy or SHR-1316, whichever is later, and have ≤ 7 days of urine or Serum pregnancy test results are negative;
• Unsterilized male patients must voluntarily use highly effective contraception during the study period until ≥120 days after the last dose of chemotherapy or SHR-1316, whichever is later.

Критерии исключения

• Received any systemic anticancer therapy, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental therapy;
• Patients with other malignancies within five years prior to the start of the trial;
• Combined with unstable systemic diseases, such as uncontrolled hypertension, severe arrhythmia, etc;
• With active, known or suspected autoimmune disease, or autoimmune paraneoplastic syndrome requiring systemic therapy;
• Allergy to the test drug;
• Have or currently have interstitial lung disease;
• Coexisting with HIV infection or active hepatitis;
• Patients who have undergone other major surgery or severe trauma within 2 months before the start of the trial;
• Pregnant or breastfeeding women;
• Those who suffer from neurological diseases or mental illnesses who cannot cooperate;
• Other reasons that investigators deem inappropriate for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Pulmonary Hospital — Shang'ai

Идентификаторы

NCT: NCT05496166 · LungMate-015

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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