Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment

NCT ID: NCT05382052

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-17
• Study Completion Date: 2027-12-30

Brief 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.

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.

Conditions

Non Small Cell Lung Cancer Stage III; Neoadjuvant Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación GECP

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariano Provencio, MD

Role: STUDY_CHAIR

President of Grupo Español de Cáncer de Pulmón

Locations

Hospital Universitario De A Coruna

A Coruña, A Coruña, Spain

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Hospital Germans Trias I Pujol

Badalona, Barcelona, Spain

Hospital Universitari Quiron Dexeus

Barcelona, Barcelona, Spain

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, Spain

Hospital De Basurto

Bilbao, Bilbao, Spain

Hospital Universitario Reina Sofia

Córdoba, Córdoba, Spain

ICO Girona, Hospital Josep Trueta

Girona, Girona, Spain

Complejo Hospitalario de Navarra

Pamplona, Iruña, Spain

Hospital Universitario de Jaén

Jaén, Jaén, Spain

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain

Hospital Universitario la Paz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Hospital Universitario Regional de Málaga

Málaga, Málaga, Spain

Hospital Universitari Son Llatzer

Palma de Mallorca, Palma de Mallorca, Spain

Hospital Clínico de Valencia

Valencia, Valencia, Spain

Hospital Universitario La Fe

Valencia, Valencia, Spain

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, Spain

Countries

Spain

Related Links

http://www.gecp.org

Description Web page of the sponsor where users can find more information about Fundacion GECP studies.

Other Identifiers

GECP 21/05_REAL-NADIM

Identifier Type: -

Identifier Source: org_study_id