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

• Conditions: NSCLC Stage IV; JS001; EGFR T790M-negative; Anlotinib

• Registration Number: NCT04116918
• Lead Sponsor: Baodong Qin

Brief 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.

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 Timeline

• Study First Submitted: 2019-07-16
• Study Start: 2019-09-01
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-03
• Last Update Submitted: 2019-10-03
• Study First Posted: 2019-10-07
• Last Update Posted: 2019-10-07
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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
Objective Response Rate	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Effect	Through study completion, an average of 1 months	Incidence of Treatment-related adverse Events
Overall Survival	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

Trial Locations

Locations (1)

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, China