Non-Small Cell Lung CancerLBM-T790MNCT07475637
Liquid Biopsy Monitoring Of EGFR T790M in Advanced Non-Small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
Trial summary
The goal of this retrospective observational study is to assess the clinical utility of plasma-based EGFR testing for detection and longitudinal monitoring of the acquired T790M resistance mutation in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) treated with first- or second-generation EGFR… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 70 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study included patients with advanced non-small cell lung cancer consulting in different hospitals in Tunisia (The Military Hospital of Tunis, Salah Azaiez Institute, Abderhamen Mami Hospital, Jendouba Hospital, Charles Nicolle Hospital of Tunis...) and referred to the Pathology Department of Charles Nicolle Hospital of Tunis for EGFR T790M monitoring using liquid biopsy.
Who may be able to join
- Confirmed advanced (stage IIIB/IV) non-small cell lung cancer
- Documented activating EGFR mutations
- Disease progression on first- or second-generation EGFR TKIs
Who cannot join
- Prior treatment with third-generation EGFR TKIs before plasma sampling
- Lack of follow-up clinical data
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Pathology Department, Charles Nicolle Hospital of Tunis
Tunis, 1007
About this study
Official title: Longitudinal Liquid Biopsy Monitoring of EGFR T790M Resistance in Advanced Non-Small Cell Lung Cancer: Real-World Data From Tunisia
The goal of this retrospective observational study is to assess the clinical utility of plasma-based EGFR testing for detection and longitudinal monitoring of the acquired T790M resistance mutation in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) treated with first- or second-generation EGFR tyrosine kinase inhibitors in routine clinical practice in Tunisia.
The main questions it aims to answer are:
- What is the detection rate of EGFR T790M mutation in plasma at the time of disease progression?
- Does repeated liquid biopsy increase the cumulative detection of T790M?
- Is T790M emergence associated with baseline clinical and molecular characteristics?
- Is T790M status associated with progression-free survival? Participants underwent plasma sampling for circulating tumor DNA analysis during follow-up, and clinical and molecular data were retrospectively collected from medical records to evaluate mutation dynamics and outcomes.
Read the detailed description
Acquired resistance to first- and second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in advanced EGFR-mutated non-small cell lung cancer (NSCLC) is most commonly mediated by the secondary EGFR T790M mutation. Identification of this resistance mechanism is clinically relevant, as it may guide subsequent treatment strategies. However, repeat tissue biopsy at disease progression is often limited by tumor inaccessibility, patient condition, or procedural risk. Plasma-based analysis of circulating tumor DNA (ctDNA) offers a minimally invasive alternative for molecular reassessment.
This retrospective real-world study evaluates the implementation of plasma EGFR testing for the detection of acquired T790M mutation in routine clinical practice in Tunisia. The study focuses on the detection rate of T790M at progression, the added value of repeated liquid biopsy sampling in initially negative cases, and the relationship between T790M emergence and baseline clinical or molecular characteristics.
In addition, longitudinal patterns of T790M appearance, persistence, or loss across serial plasma samples are explored to better understand resistance dynamics under TKI selective pressure. The association between T790M status and progression-free survival is also assessed.
By integrating molecular results with longitudinal clinical follow-up, this study seeks to characterize real-world patterns of acquired resistance and to evaluate the practical contribution of plasma-based EGFR testing to therapeutic decision-making.
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR-mutated NSCLC, EGFR T790M, Liquid biopsy, Plasma EGFR testing, Circulating tumor DNA, Serial liquid biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of EGFR T790M mutation in plasma at disease progression
Proportion of patients with detectable T790M in plasma at the time of radiological progression.
Measured: From initiation of first- or second-generation EGFR-TKI therapy until the first documented radiological disease progression at which plasma EGFR T790M testing is performed, assessed up to 36 months.
Proportion of participants with newly detected EGFR T790M on repeat liquid biopsy after an initial negative plasma result
Incremental T790M detection rate in patients with initially negative plasma results who underwent additional testing.
Measured: From the initial negative plasma EGFR T790M result at radiological disease progression until detection of T790M on repeat liquid biopsy testing during follow-up, assessed up to 36 months.
Secondary outcomes (2)
Association of T790M emergence with baseline characteristics
Correlation of T790M status with clinical and molecular features at baseline.
Measured: Baseline defined at the time of initiation of first- or second-generation EGFR-TKI therapy, before treatment exposure
Progression-free survival by T790M status
Comparison of progression-free survival in patients with versus without T790M detected in plasma.
Measured: From initiation of first- or second-generation EGFR-TKI therapy until the first radiologically confirmed disease progression, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Mar 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine of Tunis
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Charles Nicolle
- Responsible party
- Principal investigator, Soumaya RAMMEH, Faculty of Medicine of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475637
- Sponsor's protocol ID
- LB-T790M-TN
- Acronym
- LBM-T790M
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Liquid Biopsy Monitoring of EGFR T790M Resistance in Advanced Non-Small Cell Lung Cancer: Real-World Data From Tunisia
- ClinicalTrials.gov ID
- NCT07475637
- Acronym / sponsor ID
- LBM-T790M / LB-T790M-TN
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- EGFR-mutated NSCLC, EGFR T790M, Liquid biopsy, Plasma EGFR testing, Circulating tumor DNA, Serial liquid biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Faculty of Medicine of TunisUniversity, hospital or other
- Collaborators
- Hopital Charles Nicolle
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this retrospective observational study is to assess the clinical utility of plasma-based EGFR testing for detection and longitudinal monitoring of the acquired T790M resistance mutation in patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) treated with first- or second-generation EGFR tyrosine kinase inhibitors in routine clinical practice in Tunisia.
The main questions it aims to answer are:
- What is the detection rate of EGFR T790M mutation in plasma at the time of disease progression?
- Does repeated liquid biopsy increase the cumulative detection of T790M?
- Is T790M emergence associated with baseline clinical and molecular characteristics?
- Is T790M status associated with progression-free survival? Participants underwent plasma sampling for circulating tumor DNA analysis during follow-up, and clinical and molecular data were retrospectively collected from medical records to evaluate mutation dynamics and outcomes.
Detailed description
Acquired resistance to first- and second-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in advanced EGFR-mutated non-small cell lung cancer (NSCLC) is most commonly mediated by the secondary EGFR T790M mutation. Identification of this resistance mechanism is clinically relevant, as it may guide subsequent treatment strategies. However, repeat tissue biopsy at disease progression is often limited by tumor inaccessibility, patient condition, or procedural risk. Plasma-based analysis of circulating tumor DNA (ctDNA) offers a minimally invasive alternative for molecular reassessment.
This retrospective real-world study evaluates the implementation of plasma EGFR testing for the detection of acquired T790M mutation in routine clinical practice in Tunisia. The study focuses on the detection rate of T790M at progression, the added value of repeated liquid biopsy sampling in initially negative cases, and the relationship between T790M emergence and baseline clinical or molecular characteristics.
In addition, longitudinal patterns of T790M appearance, persistence, or loss across serial plasma samples are explored to better understand resistance dynamics under TKI selective pressure. The association between T790M status and progression-free survival is also assessed.
By integrating molecular results with longitudinal clinical follow-up, this study seeks to characterize real-world patterns of acquired resistance and to evaluate the practical contribution of plasma-based EGFR testing to therapeutic decision-making.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study included patients with advanced non-small cell lung cancer consulting in different hospitals in Tunisia (The Military Hospital of Tunis, Salah Azaiez Institute, Abderhamen Mami Hospital, Jendouba Hospital, Charles Nicolle Hospital of Tunis...) and referred to the Pathology Department of Charles Nicolle Hospital of Tunis for EGFR T790M monitoring using liquid biopsy.
Key inclusion criteria (3 listed)
- Confirmed advanced (stage IIIB/IV) non-small cell lung cancer
- Documented activating EGFR mutations
- Disease progression on first- or second-generation EGFR TKIs
Key exclusion criteria (2 listed)
- Prior treatment with third-generation EGFR TKIs before plasma sampling
- Lack of follow-up clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection rate of EGFR T790M mutation in plasma at disease progression
Time frame: From initiation of first- or second-generation EGFR-TKI therapy until the first documented radiological disease progression at which plasma EGFR T790M testing is performed, assessed up to 36 months.
Proportion of patients with detectable T790M in plasma at the time of radiological progression.
Proportion of participants with newly detected EGFR T790M on repeat liquid biopsy after an initial negative plasma result
Time frame: From the initial negative plasma EGFR T790M result at radiological disease progression until detection of T790M on repeat liquid biopsy testing during follow-up, assessed up to 36 months.
Incremental T790M detection rate in patients with initially negative plasma results who underwent additional testing.
2 secondary outcomes
Association of T790M emergence with baseline characteristics
Time frame: Baseline defined at the time of initiation of first- or second-generation EGFR-TKI therapy, before treatment exposure
Progression-free survival by T790M status
Time frame: From initiation of first- or second-generation EGFR-TKI therapy until the first radiologically confirmed disease progression, assessed up to 36 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Faculty of Medicine of Tunis at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of EGFR T790M mutation in plasma at disease progression (time frame: From initiation of first- or second-generation EGFR-TKI therapy until the first documented radiological disease progression at which plasma EGFR T790M testing is performed, assessed up to 36 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.