NCT03798743

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab Combined With Docetaxel	Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-30
• Completion: 2022-03-01
• First posted: 2019-01-10
• Last updated: 2022-03-02

Locations

1 site across 1 country: China