Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study (SUCCESS)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03798743 |
Recruitment Status :
Completed
First Posted : January 10, 2019
Last Update Posted : March 2, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer | Drug: Sintilimab Combined With Docetaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | January 1, 2019 |
Actual Primary Completion Date : | December 30, 2021 |
Actual Study Completion Date : | March 1, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Sintilimab Combined With Docetaxel
Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer
|
Drug: Sintilimab Combined With Docetaxel
Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w
Other Name: SCD |
- 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
- PFS (progression free survival time) [ Time Frame: Approximately 1 years ]Assessment of the disease-free progression of the subject according to RECIST 1.1
- OS (overall survival time) [ Time Frame: Approximately 1 years ]Assess the overall survival of the subject according to RECIST 1.1
- DOR (duration of response) [ Time Frame: Approximately 1 years ]Assessment of subject's duration of remission according to RECIST 1.1
- DCR (disease control rate) [ Time Frame: Approximately 1 years ]Assessment of subject's disease control rate according to RECIST 1.1
- TTR (time to response) [ Time Frame: Approximately 1 years ]Assessment of subject's objective response time according to RECIST 1.1
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798743
China, Hunan | |
Hunan Provincal Tumor Hospital | |
Changsha, Hunan, China, 410013 |
Principal Investigator: | Yongchang Zhang, MD | Hunan Cancer Hospital |
Responsible Party: | Yongchang Zhang, Professor, Hunan Province Tumor Hospital |
ClinicalTrials.gov Identifier: | NCT03798743 |
Other Study ID Numbers: |
SUCCESS |
First Posted: | January 10, 2019 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Non-small Cell Lung Cancer Sintilimab Docetaxel |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |