To hear about similar clinical trials, please enter your email below

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

NCT ID: NCT05496166

Condition: Limited Stage Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma

Conditions: Keywords:
LD-SCLC
surgery
radiotherapy
neoadjuvant chemoimmunotherapy

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: Combination Product
Intervention name: chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy
Description: 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
Arm group label: radiotherapy group
Arm group label: surgery group

Summary: 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

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Pulmonary Hospital

Address:
City: Shang'ai
Zip: 200433
Country: China

Start date: August 1, 2023

Completion date: August 1, 2030

Lead sponsor:
Agency: Shanghai Pulmonary Hospital, Shanghai, China
Agency class: Other

Collaborator:
Agency: Jiangsu HengRui Medicine Co., Ltd.
Agency class: Industry

Source: Shanghai Pulmonary Hospital, Shanghai, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05496166

Login to your account

Did you forget your password?