Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC: the SUCCESS Study

Non-small Cell Lung Cancer Clinical Trial

— SUCCESS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798743
• Other study ID #: SUCCESS
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2022
• Source: Hunan Province Tumor Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Sintilimab Combined With Docetaxel
Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w

Locations

Country	Name	City	State
China	Hunan Provincal Tumor Hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR (Overall response rate)	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	PFS (progression free survival time)	Assessment of the disease-free progression of the subject according to RECIST 1.1	Approximately 1 years
Secondary	OS (overall survival time)	Assess the overall survival of the subject according to RECIST 1.1	Approximately 1 years
Secondary	DOR (duration of response)	Assessment of subject's duration of remission according to RECIST 1.1	Approximately 1 years
Secondary	DCR (disease control rate)	Assessment of subject's disease control rate according to RECIST 1.1	Approximately 1 years
Secondary	TTR (time to response)	Assessment of subject's objective response time according to RECIST 1.1	Approximately 1 years