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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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NSCLC Stage IV EGFR T790M-negative Anlotinib JS001

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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