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

NCT05382052 | Active Not Recruiting

• 1 other identifier: GECP 21/05_REAL-NADIM
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 20

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.

Conditions

Non Small Cell Lung Cancer Stage III; Neoadjuvant Treatment

Keywords

Resectable stage IIIA; ctDNA

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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.

  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

  From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.

You may qualify if:

• \. 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.
• \. Tumor should be considered resectable before study entry by a multidisciplinary team
• \. ECOG 0-1
• \. Age ≥ 18 years at time of study entry
• \. Patients that are going to be treated with neoadjuvant treatment before surgery
• \. Patient capable of proper therapeutic compliance and accessible for correct follow-up
• \. 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.

You may not qualify if:

• \. Patients who refuse to sign and date an IRB/IEC-approved written informed consent form.
• \. No possibility of venipuncture
• \. 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.

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (20)

Hospital Universitario De A Coruna

A Coruña, A Coruña, 15006, Spain

Location

Hospital General Universitario de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitari Quiron Dexeus

Barcelona, Barcelona, 08028, Spain

Location

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital De Basurto

Bilbao, Bilbao, 48013, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, Córdoba, 14004, Spain

Location

ICO Girona, Hospital Josep Trueta

Girona, Girona, 17007, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Iruña, 31008, Spain

Location

Hospital Universitario de Jaén

Jaén, Jaén, 23007, Spain

Location

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario la Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Regional de Málaga

Málaga, Málaga, 29010, Spain

Location

Hospital Universitari Son Llatzer

Palma de Mallorca, Palma de Mallorca, 07198, Spain

Location

Hospital Clínico de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitario La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Five blood samples per patient will be collected: * Before starting neoadjuvant treatment * At the end of the neoadjuvant treatment and before the surgery * After surgery * 6 months after surgery * At first disease progression (if occurs within 24 months after surgery) The blood samples (5-10 ml each) will be collected in two Cell-Free DNA BCT tube and two PTT EDTA K2. These samples will be sent to the central laboratory the same day of extraction at room temperature. ctDNA will be extracted using the QIAamp Circulating Nucleic Acid Kit. NGS analysis of ctDNA will be performed using a panel that will target at least of 1.5 Mb and will include genes of interest.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mariano Provencio, MD

  President of Grupo Español de Cáncer de Pulmón

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: June 17, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (20)