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Report for Clinical Trial NCT02997501

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Detect EGFR T790M Mutation in ctDNA of Chinese Advanced/Metastatic NSCLC Patients by Cobas, Super-ARMS, Digital PCR and NGS and Evaluate Clinical Outcomes of T790M Mutation Positive Patients Who Had AZD9291 Monotherapy

The aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. And to assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.

NCT02997501 Lung Cancer

6 Interventions

Name: T790M+ Testing

Description: The patient will need to have T790M+ testing

Type: Procedure

AZD9291

Name: Baseline Visit Blood & Urine Testing

Description: Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria

Type: Procedure

AZD9291

Name: Baseline ECG

Description: ECG to ensure absence of any cardiac abnormality

Type: Procedure

AZD9291

Name: Visual Slit-Lamp Testing

Description: Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms

Type: Procedure

AZD9291

Name: AZD9291 Dosing

Description: Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)

Type: Drug

AZD9291

Name: Plasma AZD9291 testing

Description: The patient will need to have plasma AZD9291 testing before treatment

Type: Procedure

AZD9291


Primary Outcomes

Description: To evaluate concordance of T790M mutation plasma testing between the Cobas test and Super-ARMS platform.

Measure: Concordance of T790M mutation plasma testing between Cobas test and Super-ARMS platform

Time: Within 1- 28 days after enrollment and before study treatment

Description: To assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR- TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.

Measure: Progression Free Survival (PFS) using investigator assessments according to RECIST v1.1

Time: From first dose intake to Progression of disease (PD), up to 3 years

Description: To evaluate concordance of T790M mutation plasma testing between the Cobas test and digital PCR platform.

Measure: Concordance of T790M mutation plasma testing between Cobas test and digital PCR platform

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate concordance of T790M mutation plasma testing between the Cobas test and NGS platform.

Measure: Concordance of T790M mutation plasma testing between Cobas test and NGS platform

Time: Within 1- 28 days after enrollment and before study treatment

Secondary Outcomes

Description: To evaluate the sensitivity of Super-ARMS/digital PCR/NGS by using Cobas as the reference.

Measure: Testing sensitivity

Time: Within 1- 28 days after enrollment and before study treatment

Description: To assess the efficacy of AZD9291 monotherapy by assessment of ORR in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.

Measure: Objective Response Rate (ORR)

Time: From first dose intake to end of study, up to 3 years

Description: To assess the efficacy of AZD9291 monotherapy by assessment of OS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.

Measure: Overall Survival (OS)

Time: From first dose intake to end of study, up to 3 years

Description: To evaluate the specificity of Super-ARMS/digital PCR/NGS by using Cobas as the reference.

Measure: Testing specificity

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate PPV of Super-ARMS/digital PCR/NGS by using Cobas as the reference.

Measure: Testing positive predictive value (PPV)

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate the NPV of Super-ARMS/digital PCR/NGS by using Cobas as the reference.

Measure: Testing negative predictive value (NPV)

Time: Within 1- 28 days after enrollment and before study treatment

Other Outcomes

Description: To dynamically monitor EGFR mutations by NGS and digital PCR in ctDNA of patients receiving AZD9291 treatment.

Measure: Proportion of patients with each EGFR mutation (C797S and T790M etc.) at different time point.

Time: every 6 weeks during treatment, up to 3 years

Description: To explore the mechanisms of acquired resistance in patients who received AZD9291 treatment by NGS testing of tissue and/or blood samples from the collection at PD versus baseline.

Measure: Changes of distribution of resistance related genes at PD compared with baseline.

Time: every 6 weeks during treatment, up to 3 years

Description: To describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for AZD9291 long-term efficacy as compared to rapid PD patients.

Measure: Key genetic and proteomic markers including, but not limited to, EGFR mutations

Time: every 6 weeks during treatment, up to 3 years

Description: To evaluate concordance of EGFR mutation plasma testing by Bio-rad droplet digital PCR using other plasma test or tissue test as reference, respectively.

Measure: Testing concordance

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate sensitivity of EGFR mutation plasma testing by Bio-rad droplet digital PCR using other plasma test or tissue test as reference, respectively.

Measure: Testing sensitivity

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate specificity of EGFR mutation plasma testing by Bio-rad droplet digital PCR using other plasma test or tissue test as reference, respectively.

Measure: Testing specificity

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate PPV of EGFR mutation plasma testing by Bio-rad droplet digital PCR using other plasma test or tissue test as reference, respectively.

Measure: Testing positive predictive value (PPV)

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate NPV of EGFR mutation plasma testing by Bio-rad droplet digital PCR using other plasma test or tissue test as reference, respectively.

Measure: Testing negative predictive value (NPV)

Time: Within 1- 28 days after enrollment and before study treatment

Description: To evaluate the efficacy of patients who receive AZD9291 monotherapy and are T790M mutation positive detected by each of the five platforms, respectively.

Measure: Objective Response Rate (ORR)

Time: From first dose intake to end of study, up to 3 years

Description: To evaluate the efficacy of patients who receive AZD9291 monotherapy and are T790M mutation positive detected by each of the five platforms, respectively.

Measure: Progression Free Survival (PFS)

Time: From first dose intake to end of study, up to 3 years

Description: To evaluate the efficacy of patients who receive AZD9291 monotherapy and are T790M mutation positive detected by each of the five platforms, respectively.

Measure: Overall Survival (OS)

Time: From first dose intake to end of study, up to 3 years

Purpose: Other

Single Group Assignment


There are 2 SNPs

SNPs


1 C797S

To evaluate the NPV of Super-ARMS/digital PCR/NGS by using Cobas as the reference.. Proportion of patients with each EGFR mutation (C797S and T790M etc.) at different time point.. --- C797S ---


2 T790M

Detect EGFR T790M Mutation in ctDNA of Chinese Advanced/Metastatic NSCLC Patients by Cobas, Super-ARMS, Digital PCR and NGS and Evaluate Clinical Outcomes of T790M Mutation Positive Patients Who Had AZD9291 Monotherapy. --- T790M ---

Detect EGFR T790M Mutation in ctDNA of Chinese Advanced/Metastatic NSCLC Patients by Cobas, Super-ARMS, Digital PCR and NGS and Evaluate Clinical Outcomes of T790M Mutation Positive Patients Who Had AZD9291 Monotherapy. --- T790M --- --- T790M ---

T790M Plasma Testing Methodology Comparison and Clinical Validation The aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. --- T790M ---

T790M Plasma Testing Methodology Comparison and Clinical Validation The aim of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. --- T790M --- --- T790M ---

And to assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS. --- T790M ---

Concordance of T790M mutation plasma testing between Cobas test and Super-ARMS platform. --- T790M ---

To evaluate concordance of T790M mutation plasma testing between the Cobas test and Super-ARMS platform.. Progression Free Survival (PFS) using investigator assessments according to RECIST v1.1. --- T790M ---

To assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR- TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.. Concordance of T790M mutation plasma testing between Cobas test and digital PCR platform. --- T790M ---

To assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR- TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.. Concordance of T790M mutation plasma testing between Cobas test and digital PCR platform. --- T790M --- --- T790M ---

To evaluate concordance of T790M mutation plasma testing between the Cobas test and digital PCR platform.. Concordance of T790M mutation plasma testing between Cobas test and NGS platform. --- T790M ---

To evaluate concordance of T790M mutation plasma testing between the Cobas test and digital PCR platform.. Concordance of T790M mutation plasma testing between Cobas test and NGS platform. --- T790M --- --- T790M ---

To evaluate concordance of T790M mutation plasma testing between the Cobas test and NGS platform.. Testing sensitivity. --- T790M ---

To assess the efficacy of AZD9291 monotherapy by assessment of ORR in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.. Overall Survival (OS). --- T790M ---

To assess the efficacy of AZD9291 monotherapy by assessment of OS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-TKI therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS.. Testing specificity. --- T790M ---

To evaluate the NPV of Super-ARMS/digital PCR/NGS by using Cobas as the reference.. Proportion of patients with each EGFR mutation (C797S and T790M etc.) at different time point.. --- C797S --- --- T790M ---

To evaluate the efficacy of patients who receive AZD9291 monotherapy and are T790M mutation positive detected by each of the five platforms, respectively.. Progression Free Survival (PFS). --- T790M ---

To evaluate the efficacy of patients who receive AZD9291 monotherapy and are T790M mutation positive detected by each of the five platforms, respectively.. Overall Survival (OS). --- T790M ---

To evaluate the efficacy of patients who receive AZD9291 monotherapy and are T790M mutation positive detected by each of the five platforms, respectively.. Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. --- T790M ---

Lung Cancer Objective: The primary objective of this study is to evaluate concordance of T790M mutation plasma testing between the Cobas test and each of other platforms: Super-ARMS, digital PCR or NGS. --- T790M ---

And to assess the efficacy of AZD9291 monotherapy by assessment of PFS in adult patients with advanced or metastatic NSCLC, who have received prior EGFR-tyrosine kinase inhibitor (TKI) therapy and are T790M mutation positive detected by any one of the four plasma testing platforms: Cobas/Super-ARMS/ digital PCR/NGS. --- T790M ---

Study measures: Data collected will include patient demographics, smoking history, information needed to determine patient eligibility (including medical history, past and current disease characteristics, and tumor EGFR mutations status, T790M and sensitizing mutations status results and type of test performed), AZD9291 exposure, investigator-reported efficacy (including tumor response and disease progression), overall survival (OS), and safety (including serious adverse events [SAEs], adverse events [AEs]). --- T790M ---

Statistical methods: The concordance of T790M resistance mutation testing between the Cobas test and each of other platforms will be calculated. --- T790M ---

The Kappa coefficient will be calculated to measure the agreement of T790M mutation testing between the Cobas test and each of other platforms. --- T790M ---



HPO Nodes