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

Non Small Cell Lung Cancer Stage III Clinical Trial

— REAL-NADIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382052
• Other study ID #: GECP 21/05_REAL-NADIM
• Status: Recruiting
• Start date: June 17, 2022
• Est. completion date: December 30, 2027

Study information

• Verified date: August 2023
• Source: Fundación GECP
• Contact: Eva Pereira
• Phone: +34934302006
• Email: gecp[@]gecp.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Neoadjuvant Treatment
• Non Small Cell Lung Cancer Stage III

Locations

Country	Name	City	State
Spain	Hospital Universitario De A Coruna	A Coruña
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Germans Trias I Pujol	Badalona	Barcelona
Spain	Hospital Universitari Quiron Dexeus	Barcelona
Spain	Hospital Universitari Vall d' Hebron	Barcelona
Spain	Hospital De Basurto	Bilbao
Spain	Hospital Universitario Reina Sofia	Córdoba
Spain	ICO Girona, Hospital Josep Trueta	Girona
Spain	Hospital Universitario de Jaén	Jaén
Spain	Hospital Universitario Lucus Augusti	Lugo
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario la Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Regional de Málaga	Málaga
Spain	Hospital Universitari Son Llatzer	Palma De Mallorca
Spain	Complejo Hospitalario de Navarra	Pamplona	Iruña
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital Universitario La Fe	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación GECP

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	From date of end of neoadjuvant treatment and before surgery until the date of death, assessed up to 24 months
Secondary	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).	From the end of neoadjuvant treatment and before surgery until the death of complete response or MPR, assessed up to 24 months
Secondary	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.	From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months

External Links

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