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

Research on the Correlation Between Efficacy of Osimertinib and EGFR T790M Status and Ratio Via Digital Droplet PCR (ddPCR) From Peripheral Blood in NSCLC Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05458726

Enrollment

Registered

2022-07-14

Start date

2020-09-15

Completion date

2022-10-31

Last updated

2022-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ddPCR, EGFR T790M, Non-small Cell Lung Cancer, Osimertinib

Brief summary

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.

Interventions

DRUGOsimertinib

Osimertinib or chemotherapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
PFS	up to 1 year	Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause

Secondary

Measure	Time frame	Description
ORR	up to 1 year	the sum of CR and PR rates
DCR	up to 1 year	the sum of CR ,PR and SD rates

Countries

China

Contacts

Primary ContactJunling Li, Professor

lijunling@cicams.ac.cn+8613801178891

Backup ContactZiyi Xu

mandarin-51@hotmail.com+8618813101866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026