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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