NCT03646968

Brief Summary

The purpose of this study is to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

6.4 years

First QC Date

August 23, 2018

Last Update Submit

December 25, 2023

Conditions

Non-Squamous Non Small Cell Lung Cancer

Keywords

Anlotinib Combined With Docetaxel

Outcome Measures

Primary Outcomes (1)

  • ORR

    overall response rate

    may 2018- may 2019 (1 year)

Secondary Outcomes (2)

  • PFS

    may 2018- may 2019 (1 year)

  • OS

    may 2018- may 2019 (1 year)

Study Arms (1)

Cohorts

EXPERIMENTAL

Phase II Study to evaluate the Effectiveness and Safety of Anlotinib combined with Docetaxel in Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer

Drug: Anlotinib and Docetaxel

Interventions

Anlotinib and DocetaxelDRUG

Patients who was Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer recieved the treatment of Anlotinib and Docetaxel (Anlotinib, 12mg, po,qd and Docetaxel 175mg/m2, ivgtt, every 21day)

Cohorts

Eligibility Criteria

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

You may qualify if:

  • ，Pathologically proven Non squamous non small cell lung cancer
  • No-drive gene mutaion (EGFR、ALK、ROS1） by NGS
  • Progress after second line
  • PS score 0-2

You may not qualify if:

  • Patients received second line treatment
  • Patients received treatment of Anlotinib or Docetaxel
  • Patients with contraindication of chemotherapy
  • Pregnant or breast feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Interventions

anlotinibDocetaxel

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Yongchang Zhang, MD

    Hunan Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436yangnong0217@163.com

Yongchang Zhang, MD

CONTACT

+8613873123436zhangyongchang@csu.edu.cn

Study Design

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

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

August 1, 2018

Primary Completion

December 31, 2024

Study Completion

June 1, 2025

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

CN(1)