Non Small Cell Lung CancerCIRCULARNCT04912687
Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients
A study testing EGFR gene mutation analysis on liquid biopsy in people with Non Small Cell Lung Cancer and Advanced Solid Tumor, run by Institut Bergonié at 9 sites in France.
Trial summary
Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Advanced Solid Tumor
- What is being tested?
- EGFR gene mutation analysis on liquid biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 581 participants
- Where
- 9 sitesFrance
- Study dates
- 1 Jan 2022to 17 Jan 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥ 18 years at time of proposal study,
- Histologically confirmed non-small cell lung carcinoma,
- No previous treatment for NSCLC,
- Indication to EGFR status determination following HAS recommendation,
- Voluntary signed and dated written informed consent prior to any study specific procedure
- Patients with a social security in compliance with the French Law.
Who cannot join
- Treatment for advanced NSCLC started before liquid biopsy sampling.
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Institut de Cancérologie de l'Ouest - Site Paul Papin
Angers, 49000
Institut Bergonie
Bordeaux, 33076
CHRU Lille
Lille, 59037
Hospices Civils de Lyon
Lyon, 69002
CHU Nice-Hopital de Cimiel
Nice, 06000
Institut Curie
Paris, 75248
CHU Poitiers
Poitiers, 86021
CHU de Rennes - Hopital Pontchaillou
Rennes, 35033
CHU Strasbourg
Strasbourg, 67091
About this study
Official title: Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)
Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.
Read the detailed description
This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing).
Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.
- Conditions
- Non Small Cell Lung Cancer, Advanced Solid Tumor
- Being tested
- EGFR gene mutation analysis on liquid biopsy
- Keywords
- non-small cell lung cancer, EGFR detection, liquid biopsy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR gene mutation analysis on liquid biopsyDiagnostic test
Blood samples will be collected at inclusion for plasma DNA collection and analysis.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | For all patients, blood sample will be collected at inclusion (liquid biopsy) for sequencing.
As per standard management, for all of these patients, EGFR gene mutation will be also analyzed on archived tumor sample. Receives: Diagnostic Test: EGFR gene mutation analysis on liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis
Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure
Measured: within 3 weeks after signature of informed consent
Secondary outcomes (6)
The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only
A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by the liquid biopsy analysis if an EGFR actionable alteration is identified based on the liquid biopsy analysis
Measured: within 3 weeks after signature of informed consent
The detection rate of patients with an EGFR actionable alteration based on tissue analysis only
A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by tissue analysis if an EGFR actionable alteration is identified based on the sequencing of tumor tissue
Measured: within 3 weeks after signature of informed consent
The concordance and discordance rates between the two procedures
Concordance is defined whenever results of both techniques are identical (i.e. EGFR+ for both techniques or EGFR- for both techniques). Discordance is defined whenever results of both techniques are different.
Measured: within 3 weeks after signature of informed consent
The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)
•
Failure of a procedure (sequencing of tumor tissue or liquid biopsy) is defined whenever the procedure fails to provide an interpretable result (Reasons for failure will be collected, i.e. insufficient DNA quantity, poor DNA quality, insufficient DNA/tissue quantity, poor DNA/tissue quality, analytical failure)
Measured: within 3 weeks after signature of informed consent
Delay to obtain sequencing results
The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure
Measured: within 3 weeks after signature of informed consent
Delay for treatment initiation
The delay between the date of sample collection and the date of treatment initiation
Measured: within 3 months after signature of informed consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jan 2022
- Primary completion17 Jan 2026
- Study completion17 Jan 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multicentric prospective cohort in which newly diagnosed advanced NSCLC patients will be included. For all patients, both tumor and liquid biopsy samples will be used for sequencing and detection of EGFR gene mutation
- Masking
- None (open label)
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912687
- Sponsor's protocol ID
- IB 2021-02
- Other IDs
- 2021-A00685-36
- Acronym
- CIRCULAR
- Status last verified
- Mar 2026
- First submitted
- 28 May 2021
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)
- ClinicalTrials.gov ID
- NCT04912687
- Acronym / sponsor ID
- CIRCULAR / IB 2021-02
- Conditions
- Non Small Cell Lung Cancer, Advanced Solid Tumor
- Keywords
- non-small cell lung cancer, EGFR detection, liquid biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 17 Jan 2026 (actual)
- Study completion
- 17 Jan 2026 (actual)
- First posted
- 3 Jun 2021 (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.
Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.
Detailed description
This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing).
Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicentric prospective cohort in which newly diagnosed advanced NSCLC patients will be included. For all patients, both tumor and liquid biopsy samples will be used for sequencing and detection of EGFR gene mutation
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Diagnostic Test: EGFR gene mutation analysis on liquid biopsyFor all patients, blood sample will be collected at inclusion (liquid biopsy) for sequencing. As per standard management, for all of these patients, EGFR gene mutation will be also analyzed on archived tumor sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged ≥ 18 years at time of proposal study,
- Histologically confirmed non-small cell lung carcinoma,
- No previous treatment for NSCLC,
- Indication to EGFR status determination following HAS recommendation,
- Voluntary signed and dated written informed consent prior to any study specific procedure
Key exclusion criteria (2 listed)
- Treatment for advanced NSCLC started before liquid biopsy sampling.
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGFR gene mutation analysis on liquid biopsyBlood samples will be collected at inclusion for plasma DNA collection and analysis. | Diagnostic test | All patients |
Primary outcome
To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis
Time frame: within 3 weeks after signature of informed consent
Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure
6 secondary outcomes
The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only
Time frame: within 3 weeks after signature of informed consent
The detection rate of patients with an EGFR actionable alteration based on tissue analysis only
Time frame: within 3 weeks after signature of informed consent
The concordance and discordance rates between the two procedures
Time frame: within 3 weeks after signature of informed consent
The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)
Time frame: within 3 weeks after signature of informed consent
Delay to obtain sequencing results
Time frame: within 3 weeks after signature of informed consent
Delay for treatment initiation
Time frame: within 3 months after signature of informed consent
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 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGFR gene mutation analysis on liquid biopsy in people with Non Small Cell Lung Cancer and Advanced Solid Tumor, run by Institut Bergonié at 9 sites in France.
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 6 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 6 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 9 sites in France. 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?
To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis (time frame: within 3 weeks after signature of informed consent). 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 6 Mar 2026.