Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via ddPCR in 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

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-10-31

Brief Summary

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Liquid biopsy is emerging as an essential tool in tumor monitoring and a potential alternative and supplement to tissue biopsy for tumor genotyping, especially in relapsed or metastatic diseases. Liquid biopsy methods for detecting T790M in ctDNA can be qualitative or quantitative, including amplification refractory mutation system PCR (ARMS-PCR), digital droplet polymerase chain reaction (ddPCR), and next generation sequencing (NGS)-based methods. Comparison of multiple detecting platform for EGFR mutations in plasma samples has been undertaken in studies to determine the most feasible assay in clinical practice. In this study, we will investigate the usefulness of ddPCR for quantitative detection of EGFR T790M mutation in peripheral blood, and compared the utility of ddPCR and NGS for guiding decisions regarding osimertinib therapy in NSCLC patients who had develop resistance to first- or second generation EGFR-TKIs.

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Detailed Description

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Conditions

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EGFR T790M Osimertinib Non-small Cell Lung Cancer ddPCR

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Osimertinib

Osimertinib 80mg po daily

Group Type EXPERIMENTAL

Osimertinib

Intervention Type DRUG

Osimertinib or chemotherapy

Other treatments

chemotherapy or continuation of TKI monotherapy or in combination of anti-angiogenic agents

Group Type SHAM_COMPARATOR

Osimertinib

Intervention Type DRUG

Osimertinib or chemotherapy

Interventions

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Osimertinib

Osimertinib or chemotherapy

Intervention Type DRUG

Other Intervention Names

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paclitaxel carboplatin pemetrexed

Eligibility Criteria

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Inclusion Criteria

* histologically/cytologically confirmed stage IV NSCLC patients harboring sensitizing EGFR mutations;
* progression from first or second-generation EGFR-TKI confirmed by radiographic imaging;
* received both NGS test and ddPCR from peripheral blood simultaneously.

Exclusion Criteria

* progression from first- or second-generation EGFR-TKIs as adjuvant therapy;
* having received third-generation EGFR-TKIs prior to the gene tests;
* having received NGS test only or ddPCR test only.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No