Skip to main content
OpenTrials
Completed

NCT Number: NCT04144582

Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer

The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hunan Provincal Tumor Hospital, Changsha, Hunan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Life expectancy exceeds 3 months
  • The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.

Exclusion criteria

  • small cell lung cancer or small cell lung cancer
  • Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
  • Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);

Treatment and study plan

Sintilimab Combined With Docetaxel Monotherapy

Drug

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

Primary outcomes

  1. ORR

    Time frame: Approximately 1 years

    To measure the patients's overall response rate

Secondary outcomes

  1. PFS

    Time frame: Approximately 1 years

    Progression free survival

  2. OS

    Time frame: Approximately 1 years

    Overall survival

Sponsors and collaborators

Lead sponsor

Yongchang Zhang

Other

Registry information

Official study title

Multiple-center, Single-arm, Phase II Study on Sintilimab Combined With Docetaxel in Non-driver Gene Mutation Advanced NSCLC Patients Who Had Failed With Double Platinum-based Chemotherapy

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 30, 2019
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.