NCT05458726

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2020

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

July 7, 2022

Last Update Submit

July 21, 2022

Conditions

EGFR T790MOsimertinibNon-small Cell Lung CancerddPCR

Outcome Measures

Primary Outcomes (1)

  • PFS

    Time from initiation of osimertinib or other anti-tumor treatment to progression or death from any cause

    up to 1 year

Secondary Outcomes (2)

  • ORR

    up to 1 year

  • DCR

    up to 1 year

Study Arms (2)

Osimertinib

EXPERIMENTAL

Osimertinib 80mg po daily

Drug: Osimertinib

Other treatments

SHAM COMPARATOR

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

Drug: Osimertinib

Interventions

OsimertinibDRUG

Osimertinib or chemotherapy

Also known as: paclitaxel, carboplatin, pemetrexed
OsimertinibOther treatments

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Junling Li

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

  • Xu Z, Li Y, Wang L, Hao X, Ying J, Li J, Xing P. Efficacy of third-generation epidermal growth factor receptor-tyrosine kinase inhibitors in advanced NSCLC with different T790M statuses tested via digital droplet polymerase chain reaction ddPCR and next-generation sequencing. Expert Rev Anticancer Ther. 2024 Mar-Apr;24(3-4):183-192. doi: 10.1080/14737140.2024.2334807. Epub 2024 Apr 17.

    PMID: 38526910DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinibPaclitaxelCarboplatinPemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Junling Li, Professor

    Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junling Li, Professor

CONTACT

+8613801178891lijunling@cicams.ac.cn

Ziyi Xu

CONTACT

+8618813101866mandarin-51@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 14, 2022

Study Start

September 15, 2020

Primary Completion

July 31, 2022

Study Completion

October 31, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)