Lung CancerNEMONCT07914881
A Study to Screen for Lung Cancer in High-risk Individuals Who Have Never Smoked Using Low-dose Computed Tomography (LDCT).
An observational study of Lung Cancer and Thoracic Tumors, run by AstraZeneca.
Trial summary
A prospective, multicenter, national, observational study involving primary data collection to evaluate the lung cancer detection rate in high-risk never-smokers undergoing LDCT screening, with an exploratory evaluation of an artificial intelligence tool applied to imaging and blood collection for future ctDNA analysis Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Lung Cancer, Thoracic Tumors
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of never-smokers who have at least one prespecified high-risk factor for lung cancer, recruited from approximately 10 Brazilian centers.
Who may be able to join
- - Sign and date the informed consent form before any study-specific procedure.
- - Be a never-smoker, defined as an individual who has smoked fewer than 100 cigarettes in their lifetime and who has no history of regular use of cigars, pipes, straw cigarettes, or hookahs.
- - Men aged 50 to 74 or women aged 40 to 74 at the time of enrollment.
- - Meet at least one of the following high-risk criteria: A first-degree relative or two second-degree relatives diagnosed with lung cancer; Current or previous occupational exposure to asbestos, nickel, arsenic, beryllium, silica, or chromium for at least 1 year; Exposure for more than five years to household smoke from coal or firewood, foundry smoke, or comparable industrial smoke; Known germline mutation in genes associated with an increased risk of lung cancer, including TP53, BRCA1, BRCA2, or ATM.
- - Be physically and medically capable of undergoing a chest CT scan in the supine position.
- - Be available for follow-up according to the study schedule.
Who cannot join
- - Previous diagnosis of invasive cancer, except for in situ neoplasms or treated non-melanoma skin tumors, when deemed clinically irrelevant by the investigator.
- - History of using cigars, pipes, straw cigarettes, or hookahs on more than 100 occasions throughout their lifetime, or regular use (≥ 1 time per week for ≥ 6 consecutive months).
- - Physical inability to remain in the supine position during a chest CT scan.
- - Inability to understand, sign, or maintain informed consent.
- - A clinical condition that, in the investigator's judgment, precludes the safe performance of study procedures or the planned follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: LungScreen-NEMO: Prospective National Lung Cancer Screening Study in High-risk Never-smokers
A prospective, multicenter, national, observational study involving primary data collection to evaluate the lung cancer detection rate in high-risk never-smokers undergoing LDCT screening, with an exploratory evaluation of an artificial intelligence tool applied to imaging and blood collection for future ctDNA analysis
- Conditions
- Lung Cancer, Thoracic Tumors
- Keywords
- Lung cancer, Never-smokers, Low-dose computed tomography, LDCT, ctDNA, Thoracic oncology
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-risk never-smokers | Never-smoking men aged 50 to 74 and never-smoking women aged 40 to 74 who have at least one pre-specified high-risk factor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of confirmed lung cancer among screened participants
The primary objective is to determine the detection rate of lung cancer, with an emphasis on early-stage disease, in high-risk never-smokers undergoing LDCT screening. The analysis will estimate the rate as the number of participants with a confirmed diagnosis divided by the number of enrolled participants who underwent baseline LDCT.
Measured: From baseline assessment through the 24-month follow-up period.
Secondary outcomes (7)
Recruitment rate
To estimate the recruitment rate per center and per month.
Measured: Throughout the enrollment period, ending September 2027.
Retention rate
To estimate the retention rate between the baseline round and the 24-month follow-up assessment.
Measured: From baseline to 24 months.
Prevalence of lung cancer detected at baseline
To describe the prevalence of lung cancer detected at the baseline visit.
Measured: At baseline visit.
Incidence of lung cancer over follow-up
To describe the incidence of lung cancer over the follow-up period.
Measured: Over the 24-month follow-up period.
Diagnostic accuracy of LDCT
To evaluate the diagnostic accuracy of LDCT in detecting lung cancer, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Measured: Through study completion, approximately at 24 months.
Distribution of radiological findings
To describe the distribution of radiological findings, Lung-RADS v1.0 categories, additional procedures, referrals, and the false-positive rate.
Measured: Through study completion, approximately at 24 months.
Characterization of diagnosed tumors
Characterize the diagnosed tumors according to clinical stage, histology, diagnostic method, and time to diagnostic confirmation.
Measured: At time of diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914881
- Sponsor's protocol ID
- D133FR00247
- Acronym
- NEMO
- Status last verified
- Oct 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LungScreen-NEMO: Prospective National Lung Cancer Screening Study in High-risk Never-smokers
- ClinicalTrials.gov ID
- NCT07914881
- Acronym / sponsor ID
- NEMO / D133FR00247
- Conditions
- Lung Cancer, Thoracic Tumors
- Keywords
- Lung cancer, Never-smokers, Low-dose computed tomography, LDCT, ctDNA, Thoracic oncology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Oct 2030 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 4 Nov 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.
A prospective, multicenter, national, observational study involving primary data collection to evaluate the lung cancer detection rate in high-risk never-smokers undergoing LDCT screening, with an exploratory evaluation of an artificial intelligence tool applied to imaging and blood collection for future ctDNA analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk never-smokers | – | –Never-smoking men aged 50 to 74 and never-smoking women aged 40 to 74 who have at least one pre-specified high-risk factor. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of never-smokers who have at least one prespecified high-risk factor for lung cancer, recruited from approximately 10 Brazilian centers.
Key inclusion criteria (6 listed)
- - Sign and date the informed consent form before any study-specific procedure.
- - Be a never-smoker, defined as an individual who has smoked fewer than 100 cigarettes in their lifetime and who has no history of regular use of cigars, pipes, straw cigarettes, or hookahs.
- - Men aged 50 to 74 or women aged 40 to 74 at the time of enrollment.
- - Meet at least one of the following high-risk criteria: A first-degree relative or two second-degree relatives diagnosed with lung cancer; Current or previous occupational exposure to asbestos, nickel, arsenic, beryllium, silica, or chromium for at least 1 year; Exposure for more than five years to household smoke from coal or firewood, foundry smoke, or comparable industrial smoke; Known germline mutation in genes associated with an increased risk of lung cancer, including TP53, BRCA1, BRCA2, or ATM.
- - Be physically and medically capable of undergoing a chest CT scan in the supine position.
Key exclusion criteria (5 listed)
- - Previous diagnosis of invasive cancer, except for in situ neoplasms or treated non-melanoma skin tumors, when deemed clinically irrelevant by the investigator.
- - History of using cigars, pipes, straw cigarettes, or hookahs on more than 100 occasions throughout their lifetime, or regular use (≥ 1 time per week for ≥ 6 consecutive months).
- - Physical inability to remain in the supine position during a chest CT scan.
- - Inability to understand, sign, or maintain informed consent.
- - A clinical condition that, in the investigator's judgment, precludes the safe performance of study procedures or the planned follow-up.
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 confirmed lung cancer among screened participants
Time frame: From baseline assessment through the 24-month follow-up period.
The primary objective is to determine the detection rate of lung cancer, with an emphasis on early-stage disease, in high-risk never-smokers undergoing LDCT screening. The analysis will estimate the rate as the number of participants with a confirmed diagnosis divided by the number of enrolled participants who underwent baseline LDCT.
7 secondary outcomes
Recruitment rate
Time frame: Throughout the enrollment period, ending September 2027.
Retention rate
Time frame: From baseline to 24 months.
Prevalence of lung cancer detected at baseline
Time frame: At baseline visit.
Incidence of lung cancer over follow-up
Time frame: Over the 24-month follow-up period.
Diagnostic accuracy of LDCT
Time frame: Through study completion, approximately at 24 months.
Distribution of radiological findings
Time frame: Through study completion, approximately at 24 months.
Characterization of diagnosed tumors
Time frame: At time of diagnosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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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.
AstraZeneca Clinical Study Information Center contact
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Thoracic Tumors, run by AstraZeneca.
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 5 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: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (877-240-9479 ext. 1, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of confirmed lung cancer among screened participants (time frame: From baseline assessment through the 24-month follow-up period.). 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 4 Nov 2026.