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Clinical Trials in Spain / NCT05167487
Recruiting Observational

Pathological Response After Neoadjuvant Treatment on NSCLC

NCT05167487 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación GECP
Phase
Observational
Started
2021-12-13
Last updated
2026-02-06

Condition(s) studied

Stage IIIA Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Cisplatin →Carboplatin →

Cisplatin: Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.

Carboplatin: Route of administration: Intravenous infusion. Neoadjuvant chemotherapy is often given 2 to 4 months before surgery.

Study summary

This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with resectable stage IIIA disease (according to American Joint Committee on Cancer \[AJCC\] lung cancer edition 7 or 8) who were included in the Tumor Thoracic Registry data base and in stage IIIA clinical trials which the sponsor is Fundación GECP. * Patients with histologically N2 involvement confirmed * Patients diagnosed as stage IIIA from 2010 and 2017 * Patients who have received neoadjuvant platinum-based treatment and surgery * Age ≥ 18 years at time of study entry * PET /TC at diagnosis Exclusion Criteria: * Patients who received chemoradiotherapy neoadjuvant treatment * Patients who were not resected after neoadjuvant treatment * Patients who were diagnosed after June 2017

Primary outcome measure(s)

  • To assess pathological response after neoadjuvant treatment as a subrogate endpoint for overall survival and disease-free survival in resectable stage IIIA non-small cell lung cancer patients. — From the end of neoadjuvant treatment until the last follow up or death, assessed up to 45 months
    Pathological response will be assessed as complete pathological response, major pathological response (defined as ≤10% of viable tumor cells) and incomplete pathological response.

Trial sites (17)

FacilityCityRegionStatus
Hospital Universitario De A Coruna A Coruña A Coruña Recruiting
Hospital General Universitario de Alicante Alicante Alicante Recruiting
ICO Badalona, Hospital Germans Trias i Pujol Badalona Barcelona Recruiting
Hospital Vall d'Hebron Barcelona Barcelona Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Barcelona Recruiting
ICO Hospitalet L'Hospitalet de Llobregat Barcelona Recruiting
Hospital Universitario Insular de Gran canaria Las Palmas de Gran Canaria Gran Canaria Recruiting
Hospital Dr. Negrín Las Palmas de Gran Canaria Las Palmas Recruiting
Hospital Clínico San Carlos Madrid Madrid Recruiting
Hospital Universitario Fundación Jiménez Díaz Madrid Madrid Recruiting
Hospital 12 De Octubre Madrid Madrid Recruiting
Hospital Universitario la Paz Madrid Madrid Recruiting
Hospital Universitario Puerta de Hierro Majadahonda Madrid Recruiting
Hospital Universitario Regional de Málaga Málaga Málaga Recruiting
Complejo Hospitalario Universitario de Vigo Vigo Pontevedra Recruiting
Hospital Universitario La Fe Valencia Valencia Recruiting
Hospital Universitario Cruces Barakaldo Vizcaya Recruiting

More Fundación GECP trials in Spain

Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT) Starting soon
New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy Active, not recruiting
Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases Active, not recruiting
DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors Active, not recruiting
Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05167487 on ClinicalTrials.gov ↗ ← All trials in Spain