- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03798743
Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study (SUCCESS)
Single Center, Single Arm Phase II Study on Efficacy Evaluation and Bio-marker Analysis of Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Hunan Provincal Tumor Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sign written informed consent before any trial-related processes are implemented
- Age ≥ 18 years old and ≤ 75 years old
- Life expectancy exceeds 3 months
- The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard
- Histological or cytological diagnosis of NSCLC and stage IIIB/IV stage tumors (according to the International Association for the Study of Lung Cancer)Chest tumor staging manual 8th edition judgment) or in multimodal treatment (radiotherapy, surgical resection or radical chemoradiotherapy local treatment)Subjects with relapse or disease progression after treatment for locally advanced disease.
Subjects must have previously been treated with a platinum-containing dual chemotherapy (carboplatin or cisplatin) regimen for advanced or metastatic tumorsisease progression occurred during or after the period.
i) receiving maintenance therapy (referring to treatment with no progress after treatment with a platinum-containing dual chemotherapy regimen) and progress Subjects are eligible for inclusion. Ii) treatment of locally advanced disease with platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy, and completion of treatment Subjects with tumor recurrence or metastasis within 6 months after treatment are eligible.selected.
Iii) administration of platinum-containing adjuvant, neoadjuvant therapy or radical chemoradiotherapy for treatment of locally advanced disease >6 months laterTumor recurrence, and later progressed during or after treatment of a recurrent tumor with a platinum-based regimen Subjects are eligible for inclusion.
- Patients confirmed by histological specimens who are not eligible for EGFR, ALK or ROS1 targeted therapy (with no tumor) EGFR-sensitive mutations and no evidence of ALK, ROS1 gene rearrangement);
- The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1
- Good hematopoietic function, defined as absolute neutrophil count ≥1.5×109/L, platelet count ≥100×109/L, hemoglobin≥90g/L [no blood transfusion or erythropoietin (EPO) within 7 days] Dependency];
- Good liver function, defined as total bilirubin level ≤ normal upper limit (ULN); patients without liver metastases, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 1.5 times ULN, alkaline phosphatase ≤ 2.5 times ULN For patients with recorded liver metastases, AST and ALT levels ≤ 5 times ULN;
Exclusion Criteria:
- Small cell lung cancer
- Currently participating in interventional clinical research treatment, or receiving other research medications within 4 weeks prior to the first dose or Used research equipment;
- Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulus or association a drug that inhibits T cell receptors (eg, CTLA-4, OX-40, CD137);
- Systemic systemic treatment of Chinese patent medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use of pleural effusion) with anti-lung cancer indications within 2 weeks prior to the first dose, or before the first dose Major surgical treatment within 3 weeks;
- Pulmonary radiation therapy >30 Gy within 6 months prior to first dose
- Completed palliative radiotherapy within 7 days prior to the first dose
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sintilimab Combined With Docetaxel
Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer
|
Sintilimab 200mgi.v
q3w Docetaxel 75mg/m2 i.v q3w
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR (Overall response rate)
Time Frame: Approximately 1 years
|
Evaluation of objective response rates in patients with advanced or metastatic non-small cell lung cancer who failed to receive platinum-based dual-drug chemotherapy in response to RECIST 1.1 and in combination with docetaxel and docetaxel
|
Approximately 1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS (progression free survival time)
Time Frame: Approximately 1 years
|
Assessment of the disease-free progression of the subject according to RECIST 1.1
|
Approximately 1 years
|
OS (overall survival time)
Time Frame: Approximately 1 years
|
Assess the overall survival of the subject according to RECIST 1.1
|
Approximately 1 years
|
DOR (duration of response)
Time Frame: Approximately 1 years
|
Assessment of subject's duration of remission according to RECIST 1.1
|
Approximately 1 years
|
DCR (disease control rate)
Time Frame: Approximately 1 years
|
Assessment of subject's disease control rate according to RECIST 1.1
|
Approximately 1 years
|
TTR (time to response)
Time Frame: Approximately 1 years
|
Assessment of subject's objective response time according to RECIST 1.1
|
Approximately 1 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- SUCCESS
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.
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