CClinicalTrials.gg
Status unknownNCT05458726Updated Jul 26, 2022

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

A Phase 2 interventional study of Osimertinib in EGFR T790M, Osimertinib and Non-small Cell Lung Cancer, sponsored by Peking Union Medical College. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Peking Union Medical College · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Sep 2020, registered Jul 2022).
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • EGFR T790M
  • Osimertinib
  • Non-small Cell Lung Cancer
  • ddPCR
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's planned enrollment of 80 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Peking Union Medical College is the lead sponsor of 58 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Osimertinib

    Osimertinib 80mg po daily

    Drug: Osimertinib

  • Sham comparator
    Other treatments

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

    Drug: Osimertinib

Interventions

  • DrugOsimertinib

    Osimertinib or chemotherapy

    Also known as: paclitaxel, carboplatin, pemetrexed

06

What researchers measure

Primary outcomes

  1. PFS

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

    Time frame: up to 1 year

Secondary outcomes

  1. ORR

    the sum of CR and PR rates

    Time frame: up to 1 year

  2. DCR

    the sum of CR ,PR and SD rates

    Time frame: up to 1 year

07

Study locations

1 of 1 sites recruiting
  • Junling Li
    Beijing, Beijing 100021, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05458726
Lead sponsor
Peking Union Medical College
Responsible party
Junling Li (Professor, Peking Union Medical College) — Principal investigator
First posted
Jul 14, 2022
Start date
Sep 15, 2020
Primary completion
Jul 31, 2022 (estimated)
Completion
Oct 31, 2022 (estimated)
Last update
Jul 26, 2022

Study contacts

Junling Li, Professor
Contact
lijunling@cicams.ac.cn
+8613801178891
Ziyi Xu
Contact
mandarin-51@hotmail.com
+8618813101866
Junling Li, Professor
principal investigator · Chinese Academy of Medical Sciences and Peking Union Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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