Clinical Trial on NSCLC Stage IV, Anlotinib, EGFR T790M-negative, JS001 - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Detailed Description

All EGFR mutation NSCLC patients with EGFR-TKIs eventually develop acquired resistance and in 40%-50% of these the resistance mechanism is based on the EGFR T790M mutation who could receive Osimertinib. Several alternative mechanisms of escape from EGFR-TKIs have been detected in NSCLC patients without the T790M, such as Met application, BRAF mutation, PIK3CA mutation, etc, who could receive the combination of EGFR-TKI with comparable target drug. Given the lack of targeted therapy for the majority of T790M-negative patients, platinum-doublet chemotherapy remains the standard of care with low effectiveness. In the present study, we aimed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- - Shanghai, China
    - Recruiting
    - Shanghai Changzheng Hospital
    - Contact:
      
      Xiao-Dong Jiao, MD.PHD
      
      Phone Number: +86-13817797639
      
      Email: pulava@139.com
    - Principal Investigator:
      
      Yuan-sheng Zang, MD.PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

EGFR-TKI Resistant T790M-Negative NSCLC

Description

Inclusion Criteria:

Adult patients >=18 years of age
Inoperable locally advanced, recurrent, and/or metastatic NSCLC patients with EGFR sensitive mutation
EGFR-TKI resistent
EGFR T790M negative
Expected survival ≥ 3 month;
ECOG / PS score: 0-2;
the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

EGFR-T790M positive
with druggable gene alteration;
Patient can not comply with research program requirements or follow-up;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate Time Frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Progression-Free Survival (PFS) Time Frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months	Time from treatment beginning until disease progression	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months	Time from treatment beginning until death from any cause	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Adverse Effect Time Frame: Through study completion, an average of 1 months	Incidence of Treatment-related adverse Events	Through study completion, an average of 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baodong Qin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ANTICIPATED)

September 30, 2021

Study Completion (ANTICIPATED)

September 30, 2021

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

October 3, 2019

First Posted (ACTUAL)

October 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)