NCT04144582

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 2, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

October 28, 2019

Last Update Submit

March 1, 2022

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • ORR

    To measure the patients's overall response rate

    Approximately 1 years

Secondary Outcomes (2)

  • PFS

    Approximately 1 years

  • OS

    Approximately 1 years

Study Arms (1)

Sintilimab Combined With Docetaxel

EXPERIMENTAL

Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer

Drug: Sintilimab Combined With Docetaxel Monotherapy

Interventions

Sintilimab Combined With Docetaxel MonotherapyDRUG

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

Sintilimab Combined With Docetaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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);

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hunan Provincal Tumor Hospital

Changsha, Hunan, 410013, China

Location

Yongchang Z MD

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yongchang Z MD, MD

    Hunan Province Tumor Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 28, 2019

First Posted

October 30, 2019

Study Start

January 1, 2019

Primary Completion

September 30, 2020

Study Completion

December 31, 2021

Last Updated

March 2, 2022

Record last verified: 2022-03

Locations

CN(2)