Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC

NSCLC Stage IV Clinical Trial

Official title:

Efficacy and Safety of the Combination of Anlotinib and JS001 in EGFR-TKI Resistant T790M-Negative NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116918
• Other study ID #: AJERTNN
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2019
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to evaluate the efficacy and safety of the combination of Anlotinb and JS001 in EGFR-TKI resistant T790M-negative NSCLC patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Anlotinib
• Carcinoma, Non-Small-Cell Lung
• EGFR T790M-negative
• JS001
• NSCLC Stage IV

Locations

Country	Name	City	State
China	Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Baodong Qin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	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
Primary	Objective Response Rate	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
Secondary	Overall Survival	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
Secondary	Adverse Effect	Incidence of Treatment-related adverse Events	Through study completion, an average of 1 months