ClinicalTrials.gg
Sign In
Enrolling by invitationNCT06730477Updated Dec 12, 2024

Plasma Exosomes Reveal the Efficacy of Targeted Therapy in Patients With EGFR Mutation in Lung Adenocarcinoma

An observational study in Lung Adenocarcinoma and EGFR Activating Mutation, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-12.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The objective of this observational study is to explore the therapeutic trajectory of targeted therapy in lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. The main objective is to identify potential biomarkers that can predict the efficacy of targeted therapy through plasma exosomes and to explore strategies to reverse drug resistance to targeted therapy. Biological specimens and medical imaging data will be collected from patients already receiving targeted therapy as a first-line treatment, and followed-up will be conducted to analyze prognosis based on different patterns.

Read the detailed description

The medical imaging data will be collected retrospectively and prospectively, and the blood samples and tumor tissues will be collected prospectively.

02

Conditions studied

  • Lung Adenocarcinoma
  • EGFR Activating Mutation
03

In context

Adenocarcinoma of Lung

315 studies on the registry are indexed under Adenocarcinoma of Lung; 83 are open to participants now.

This study's planned enrollment of 500 is above the median of 201 across 84 observational studies indexed under Adenocarcinoma of Lung.

Browse Adenocarcinoma of Lung studies →

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 172 studies on the registry; 136 are open to participants now.

Browse Union Hospital, Tongji Medical College, Huazhong University of Science and Technology studies →

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

From January 2021 to December 2026, about 500 patients with EGFR-mutated lung adenocarcinoma who receive targeted therapy with or without chemotherapy as first-line treatment will be included in this cohort study

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pathological examination confirmed lung adenocarcinoma
  • No other type of tumor was present
  • Common sensitive EGFR (Ex19Del L858R or combined with other sites) mutations have been identified
  • Receive targeted therapy with or without chemotherapy as first-line treatment
  • ≥ 18 years and ≤80 years old

Exclusion criteria

Exclusion Criteria:

  • History of other malignant tumors
  • Irregular treatment or poor compliance
  • Incomplete clinical information or lost to follow-up
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Untreated EGFR mutated lung adenocarcinoma patients

    Patients diagnosed with lung adenocarcinoma with EGFR mutations for the first time.

    Other: observational study

  • Patients with EGFR-mutated lung adenocarcinoma who are responding to targeted therapy

    Patients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in the response stage.

    Other: observational study

  • Patients with EGFR-mutated lung adenocarcinoma who are resistant to targeted therapy

    Patients with EGFR-mutated lung adenocarcinoma treated with targeted therapy combined with or without chemotherapy as first-line therapy, and the therapeutic effect was in drug resistance stage, or disease progression.

    Other: observational study

Interventions

  • Otherobservational study

    Efficacy of targeted therapy combined with or without chemotherapy as first-line therapy in patients with EGFR-mutated lung adenocarcinoma.

06

What researchers measure

Primary outcomes

  1. progression-free survival

    The time of disease progression is evaluated according to the Response Evaluation Criteria in Solid Tumors, version 1.1.

    Time frame: A two-year period after starting treatment (Regular follow-up every three months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)

Secondary outcomes

  1. Overall survival

    The survival time after receiving targeted therapy combined with or without chemotherapy as first-line treatment

    Time frame: A three-year period after starting treatment (Regular follow-up every six months after receiving targeted therapy combined with or without chemotherapy as first-line treatment)

07

Study locations

1 site
  • Union hospital, Tongji Medical college, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2021 (actual). Primary completion is estimated for Dec 2026, 71 months after the start.

Of 36 observational studies under Adenocarcinoma of Lung, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's planned 71 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 12, 2024
First posted
Dec 12, 2024
StartActual
Jan 1, 2021
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2027
Last update
Dec 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06730477
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators
Yichang Central People's Hospital, Suizhou Hospital, Hubei University of Medicine
Responsible party
Yang Jin (deputy dean, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology) — Principal investigator
First posted
Dec 12, 2024
Start date
Jan 1, 2021
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Dec 12, 2024

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Adenocarcinoma of Lung →

Other studies from this sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology →

Start the discussion