Non Small Cell Lung Cancer Stage IIIREAL-NADIMNCT05382052
Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
An observational study of Non Small Cell Lung Cancer Stage III and Neoadjuvant Treatment, run by Fundación GECP at 20 sites in Spain.
Trial summary
This is an observational, prospective, multicentre and nationwide study. The study enroll resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Stage III, Neoadjuvant Treatment
- How many people
- 100 participants
- Where
- 20 sitesSpain
- Study dates
- 17 Jun 2022to 30 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.
Who may be able to join
- 1. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included.
- 2. Tumor should be considered resectable before study entry by a multidisciplinary team
- 3. ECOG 0-1
- 4. Age ≥ 18 years at time of study entry
- 5. Patients that are going to be treated with neoadjuvant treatment before surgery
- 6. Patient capable of proper therapeutic compliance and accessible for correct follow-up
- 7. Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
Who cannot join
- 1. Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
- 2. No possibility of venipuncture
- 3. Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Hospital Universitario De A Coruna
A Coruña, A Coruña, 15006
Hospital General Universitario de Alicante
Alicante, Alicante, 03010
Hospital Germans Trias I Pujol
Badalona, Barcelona, 08916
Hospital Universitari Quiron Dexeus
Barcelona, Barcelona, 08028
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, 08035
Hospital De Basurto
Bilbao, Bilbao, 48013
Hospital Universitario Reina Sofia
Córdoba, Córdoba, 14004
ICO Girona, Hospital Josep Trueta
Girona, Girona, 17007
Hospital Universitario de Jaén
Jaén, Jaén, 23007
Hospital Universitario Lucus Augusti
Lugo, Lugo, 27003
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Universitario la Paz
Madrid, Madrid, 28046
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario Regional de Málaga
Málaga, Málaga, 29010
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, 07198
Complejo Hospitalario de Navarra
Pamplona, Iruña, 31008
Hospital Clínico de Valencia
Valencia, Valencia, 46010
Hospital Universitario La Fe
Valencia, Valencia, 46026
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
About this study
This is an observational, prospective, multicentre and nationwide study.
The study enroll resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.
The primary objective of this study is evaluating whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.
Read the detailed description
This is an observational, multicenter, one-arm, non-comparative, prospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of blood samples at five times and patient data, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.
Approximately 100 resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world will be recruited for this study in Spain. With this figure, it can be estimated whether ctDNA, both baseline and its negativization, has a role as a prognostic marker in the evolution of these patients in real-life conditions.
The primary objective of this study is evaluate whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.
The study is planned with the recruitment of patients over a year to a follow-up of 36 months post-surgery.
- Keywords
- Resectable stage IIIA, ctDNA
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | The study is based on a blood sample analysis in stage IIIA non-small lung cancer patients that are going to receive neoadjuvant treatment in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. Prospective information about treatment after neoadjuvant treatment and after the last blood extraction will not be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and progression free survival (PFS).
To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and PFS
Measured: From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months
Secondary outcomes (3)
To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and overall survival.
To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and Overall Survival
Measured: From date of end of neoadjuvant treatment and before surgery until the date of death, assessed up to 24 months
To evaluate whether there is a significant association between ctDNA clearance and pathological complete response or major pathologic response.
To assess the association between the baseline ctDNA and ctDNA clearance with each one of the two outcomes: after complete response or major pathologic response (MPR).
Measured: From the end of neoadjuvant treatment and before surgery until the death of complete response or MPR, assessed up to 24 months
To identify somatic mutations in ctDNA that predispose to a better/worse overall survival
To identify somatic mutations in ctDNA in the pre-treatment plasma that predispose to a better/worse overall survival.
Measured: From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start17 Jun 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
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 Cancer Stage IIIStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Provencio, MD, Study chair, President of Grupo Español de Cáncer de Pulmón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382052
- Sponsor's protocol ID
- GECP 21/05_REAL-NADIM
- Acronym
- REAL-NADIM
- Status last verified
- Nov 2025
- First submitted
- 16 May 2022
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT05382052
- Acronym / sponsor ID
- REAL-NADIM / GECP 21/05_REAL-NADIM
- Keywords
- Resectable stage IIIA, ctDNA
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 19 May 2022 (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.
This is an observational, prospective, multicentre and nationwide study.
The study enroll resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.
The primary objective of this study is evaluating whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.
Detailed description
This is an observational, multicenter, one-arm, non-comparative, prospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the collection of blood samples at five times and patient data, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice.
Approximately 100 resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world will be recruited for this study in Spain. With this figure, it can be estimated whether ctDNA, both baseline and its negativization, has a role as a prognostic marker in the evolution of these patients in real-life conditions.
The primary objective of this study is evaluate whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.
The study is planned with the recruitment of patients over a year to a follow-up of 36 months post-surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –The study is based on a blood sample analysis in stage IIIA non-small lung cancer patients that are going to receive neoadjuvant treatment in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. Prospective information about treatment after neoadjuvant treatment and after the last blood extraction will not be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.
Key inclusion criteria (7 listed)
- 1. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included.
- 2. Tumor should be considered resectable before study entry by a multidisciplinary team
- 3. ECOG 0-1
- 4. Age ≥ 18 years at time of study entry
- 5. Patients that are going to be treated with neoadjuvant treatment before surgery
Key exclusion criteria (3 listed)
- 1. Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
- 2. No possibility of venipuncture
- 3. Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
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
To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and progression free survival (PFS).
Time frame: From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months
To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and PFS
3 secondary outcomes
To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and overall survival.
Time frame: From date of end of neoadjuvant treatment and before surgery until the date of death, assessed up to 24 months
To evaluate whether there is a significant association between ctDNA clearance and pathological complete response or major pathologic response.
Time frame: From the end of neoadjuvant treatment and before surgery until the death of complete response or MPR, assessed up to 24 months
To identify somatic mutations in ctDNA that predispose to a better/worse overall survival
Time frame: From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months
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 19 Nov 2025.
- Description Web page of the sponsor where users can find more information about Fundacion GECP studies.Link provided by the sponsor.
- 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.
Mariano Provencio, MD study chair
President of Grupo Español de Cáncer de Pulmón
20 sites 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 Stage III and Neoadjuvant Treatment, run by Fundación GECP at 20 sites in Spain.
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 7 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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?
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?
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 evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and progression free survival (PFS). (time frame: From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months). 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 Nov 2025.