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Report for Clinical Trial NCT04116918

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT04116918 NSCLC Stage IV EGFR T790M-negative Anlotinib JS001
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma


Primary Outcomes

Description: Time from treatment beginning until disease progression

Measure: Progression-Free Survival (PFS)

Time: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months

Description: Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission.

Measure: Objective Response Rate

Time: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months

Secondary Outcomes

Description: Time from treatment beginning until death from any cause

Measure: Overall Survival

Time: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months

Description: Incidence of Treatment-related adverse Events

Measure: Adverse Effect

Time: Through study completion, an average of 1 months

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 T790M

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

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

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

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

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

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

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

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

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

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. --- T790M ---

Given the lack of targeted therapy for the majority of T790M-negative patients, platinum-doublet chemotherapy remains the standard of care with low effectiveness. --- T790M ---

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. --- T790M ---



HPO Nodes


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