- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05496166
The Efficiency of Surgery and Radiotherapy After SHR-1316 (Adebrelimab) and Platinum-containing Doublet Induction Therapy for Limited-stage Small Cell Lung Cancer
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Shanghai
-
Shang'ai, Shanghai, China, 200433
- Shanghai Pulmonary Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: surgery group
SHR-1316+chemotherapy+surgery
|
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
|
Active Comparator: radiotherapy group
SHR-1316+chemotherapy+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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival
Time Frame: 2 years
|
It refers to the time from the first administration of SHR1316 in this study to the disease progression or death (including any cause of death in the case of no progression) , regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of adverse events
Time Frame: through study completion, an average of 1.5 years
|
The frequency of severe adverse events as assessed by CTCAE 5.0 from the participants enrolling to 90 days after the last drug administration or 30 days after surgery or new anti-cancer therapy, which comes first.
|
through study completion, an average of 1.5 years
|
pathological response
Time Frame: up to 5 months
|
To evaluate the pathological response rate (major pathological response and complete pathological response) 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)
|
up to 5 months
|
objective response rate
Time Frame: through study completion, an average of 1.5 years
|
It refers to the proportion of patients who have had a complete response or partial response (according to RECIST1.1) as confirmed by CT evaluation
|
through study completion, an average of 1.5 years
|
overall survival
Time Frame: up to 60 months
|
It is defined as the time from enrollment to death of participant due to any cause.
In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date.
|
up to 60 months
|
recurrence free survival
Time Frame: up to 60 months
|
It is defined as the time from enrollment to recurrence in patients who received surgery
|
up to 60 months
|
the duration of response(DOR)
Time Frame: up to 60 months
|
the time from the date when the response criteria of complete response or partial response is first met to the date of progression/relapse or death.
|
up to 60 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biological predicted markers
Time Frame: through study completion, an average of 1.5 years
|
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
|
through study completion, an average of 1.5 years
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LungMate-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Limited Stage Small Cell Lung Cancer
-
Shanghai Chest HospitalRecruitingSmall Cell Lung Carcinoma | Small-cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive Stage | Small Cell Lung Cancer, Combined TypeChina
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
European Organisation for Research and Treatment...UNICANCERRecruitingExtensive-stage Small-cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited Kingdom, Belgium, Switzerland, Italy, France, Germany, Poland, Spain, Austria
-
Intergroupe Francophone de Cancerologie ThoraciqueCompletedSmall Cell Lung Cancer | Small Cell Lung Cancer Limited Stage | Small Cell Lung Cancer Extensive StageFrance
-
Vanderbilt-Ingram Cancer CenterMerck Sharp & Dohme LLCRecruitingLimited Stage Lung Small Cell Carcinoma | Stage III Lung Cancer | Stage I Lung Cancer | Stage II Lung CancerUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedTobacco Use Disorder | Stage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB...United States
-
National Cancer Institute (NCI)NRG OncologyActive, not recruitingStage III Lung Cancer AJCC v8 | Stage II Lung Cancer AJCC v8 | Limited Stage Lung Small Cell Carcinoma | Stage I Lung Cancer AJCC v8United States, Japan
-
National Cancer Institute (NCI)CompletedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)TerminatedExtensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Limited Stage Small Cell Lung CancerUnited States
-
University of Colorado, DenverAriad PharmaceuticalsCompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Limited Stage Small Cell Lung Cancer | Adenocarcinoma of the LungUnited States
Clinical Trials on chemotherapy and SHR-1316(Adebrelimab) comnined with surgery or radiotherapy
-
Maastricht Radiation OncologyCompletedNon-small Cell Lung Cancer | Stage IV (Oligo-metastases)Netherlands
-
Mian XIRecruitingHepatocellular CarcinomaChina
-
Harbin Medical UniversityNot yet recruitingExtensive-stage Small-cell Lung Cancer
-
Swiss Group for Clinical Cancer ResearchRecruitingNon-small Cell Lung Cancer (NSCLC) | Stage IVSwitzerland
-
Liaoning Tumor Hospital & InstituteNot yet recruitingNon Small Cell Lung Cancer
-
Korea Cancer Center HospitalGachon University Gil Medical Center; The Catholic University of Korea; Gangnam... and other collaboratorsUnknownRectal Cancer | Liver Metastasis | Lung MetastasisKorea, Republic of
-
National Cancer Center Hospital EastJapan Agency for Medical Research and Development; Japan Clinical Oncology...Recruiting
-
Tata Memorial CentreAll India Institute of Medical Sciences, New Delhi; Amrita Institute of Medical...Not yet recruitingStage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 | Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8India
-
University of ChicagoCompletedOropharyngeal Squamous Cell CarcinomaUnited States
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedHead and Neck CancerUnited States