Clinical trial NCT05382052: Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
Official title: Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer Stage III
Neoadjuvant Treatment
Keywords: Resectable stage IIIA
ctDNA
Lead sponsor: Fundación GECP
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and progression free survival (PFS).
timeFrame: From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months
Secondary outcomes:
measure: To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and overall survival.
timeFrame: From date of end of neoadjuvant treatment and before surgery until the date of death, assessed up to 24 months
measure: To evaluate whether there is a significant association between ctDNA clearance and pathological complete response or major pathologic response.
timeFrame: From the end of neoadjuvant treatment and before surgery until the death of complete response or MPR, assessed up to 24 months
measure: To identify somatic mutations in ctDNA that predispose to a better/worse overall survival
timeFrame: From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias I Pujol
state: Barcelona
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Iruña
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: A Coruña
country: Spain
facility: Hospital Universitario De A Coruna
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Quiron Dexeus
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d' Hebron
city: Bilbao
country: Spain
facility: Hospital De Basurto
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Girona
country: Spain
facility: ICO Girona, Hospital Josep Trueta
city: Jaén
country: Spain
facility: Hospital Universitario de Jaén
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario la Paz
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
city: Palma De Mallorca
country: Spain
facility: Hospital Universitari Son Llatzer
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
affiliation: President of Grupo Español de Cáncer de Pulmón
name: Mariano Provencio, MD
role: STUDY_CHAIR
References: