Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study (SUCCESS)
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ClinicalTrials.gov Identifier: NCT03798743 |
Recruitment Status :
Completed
First Posted : January 10, 2019
Last Update Posted : March 2, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | January 5, 2019 | ||||
First Posted Date ICMJE | January 10, 2019 | ||||
Last Update Posted Date | March 2, 2022 | ||||
Actual Study Start Date ICMJE | January 1, 2019 | ||||
Actual Primary Completion Date | December 30, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
ORR [ 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
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | The study aim to Evaluate the combination of ididilimumab and docetaxel alone in the treatment of previous platinum-containing double-drug chemotherapy according to RECIST 1.1Objective remission rate of advanced or metastatic non-small cell lung cancer with negative, driving gene negative (EGFR, ALK, ROS1); (ORR). | ||||
Detailed Description | This study is a single case of syndilizumab plus docetaxel monotherapy in a Chinese-negative late-stage or metastatic non-small cell lung cancer (NSCLC) failed platinum-containing dual-drug chemotherapy. Center, single arm phase II study. In this study, 30 patients with advanced or metastatic non-small cell lung cancer who had failed platinum-containing dual-drug chemotherapy were treated with rituximab plus docetaxel every 3 weeks until disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other cessation of treatment as prescribed by the program, whichever occurs first. The primary end point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review Board (IRRC). The longest treatment time for ididibizumab is 24 months. An interim analysis will be conducted during the course of the study. The results and reports will be provided to the Independent Data Audit Committee (IDMC), which determines whether the trial is valid based on the valid cut-off value of the trial and whether the study data can be submitted in advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and the sponsor. The responsibilities and related procedures of IDMC members will be defined in the IDMC charter. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-small Cell Lung Cancer | ||||
Intervention ICMJE | Drug: Sintilimab Combined With Docetaxel
Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w
Other Name: SCD
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Study Arms ICMJE | Experimental: Sintilimab Combined With Docetaxel
Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer
Intervention: Drug: Sintilimab Combined With Docetaxel
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Publications * | Zhang Y, Song L, Zeng L, Xiong Y, Liu L, Zhou C, Yang H, Wang Z, Xia Q, Jiang W, Xu Q, Yang N. Sintilimab plus docetaxel as second-line therapy of advanced non-small cell lung cancer without targetable mutations: a phase II efficacy and biomarker study. BMC Cancer. 2022 Sep 5;22(1):952. doi: 10.1186/s12885-022-10045-0. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 1, 2022 | ||||
Actual Primary Completion Date | December 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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.
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03798743 | ||||
Other Study ID Numbers ICMJE | SUCCESS | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Yongchang Zhang, Hunan Province Tumor Hospital | ||||
Original Responsible Party | Wenxiang Wang, Hunan Province Tumor Hospital, Professor | ||||
Current Study Sponsor ICMJE | Hunan Province Tumor Hospital | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Hunan Province Tumor Hospital | ||||
Verification Date | March 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |