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

NCT03798743 | Completed Phase 2

• 1 other identifier: SUCCESS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Sintilimab; Docetaxel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• PFS (progression free survival time)

  Approximately 1 years

• OS (overall survival time)

  Approximately 1 years

• DOR (duration of response)

  Approximately 1 years

• DCR (disease control rate)

  Approximately 1 years

• TTR (time to response)

  Approximately 1 years

Study Arms (1)

Sintilimab Combined With Docetaxel

EXPERIMENTAL

Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer

Drug: Sintilimab Combined With Docetaxel

Interventions

Sintilimab Combined With Docetaxel DRUG

Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w

Also known as: SCD

Sintilimab Combined With Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

Location

Related Publications (1)

• 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.

  PMID: 36064386 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2019
• First Posted: January 10, 2019
• Study Start: January 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: March 1, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

CN (1)