Examining immune responses in advanced lung cancer patients after treatment
Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA/B and IIIC NSCLC Patients Treated in Real World.
This study looks at how the immune system responds in patients with advanced lung cancer after they receive a combination of chemotherapy, radiation, and immunotherapy to see how these treatments work together.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación GECP Academic / other |
| Drugs / interventions | Durvalumab, immunotherapy |
| Locations | 22 sites (Ferrol, A Coruña and 21 other locations) |
| Trial ID | NCT06634199 on ClinicalTrials.gov |
What this trial studies
This observational study aims to describe the antitumor immune response in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have received chemoradiotherapy (cCRT) followed by immunotherapy (Durvalumab). It will collect and analyze secondary data from patient clinical charts and blood samples over a three-year period. The study focuses on patients who have not progressed after cCRT and are treated according to standard clinical practices. The goal is to understand how these treatments interact and affect immune responses in real-world settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with unresectable stage IIIA-IIIC NSCLC and a PD-L1 expression greater than 1% who have not progressed after cCRT.
Not a fit: Patients who are not receiving immunotherapy or those with progressing disease after cCRT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of immunotherapy following chemoradiotherapy in advanced lung cancer, potentially improving treatment strategies.
How similar studies have performed: Other studies have shown promise in understanding immune responses in lung cancer treatments, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology). * ECOG 0-1. * PDL1\>1%. * Age ≥ 18 years at time of study * Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice * 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. Exclusion Criteria: * 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.
Where this trial is running
Ferrol, A Coruña and 21 other locations
- Complejo Hospitalario Universitario Del Ferrol — Ferrol, A Coruña, Spain (Recruiting)
- Hospital General Universitario de Alicante — Alicante, Alicante, Spain (Recruiting)
- ICO Badalona, Hospital Germans Trias i Pujol — Badalona, Barcelona, Spain (Recruiting)
- Hospital Universitari Vall d' Hebron — Barcelona, Barcelona, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Barcelona, Spain (Recruiting)
- Hospital De Basurto — Bilbao, Bilbao, Spain (Recruiting)
- Hospital General Universitario de Ciudad Real — Ciudad Real, Ciudad Real, Spain (Recruiting)
- ICO Girona, Hospital Josep Trueta — Girona, Girona, Spain (Recruiting)
- Hospitalario Universitario A Coruña — A Coruña, La Coruña, Spain (Recruiting)
- Hospital Universitari de Gran Canària Doctor Negrín — Las Palmas de Gran Canaria, Las Palmas, Spain (Recruiting)
- Hospital Universitario Lucus Augusti — Lugo, Lugo, Spain (Recruiting)
- Hospital Universitario De La Princesa — Madrid, Madrid, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario La Paz — Madrid, Madrid, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (Recruiting)
- Hospital Universitario Central De Asturias — Oviedo, Oviedo, Spain (Recruiting)
- Hospital Universitario Nuestra Señora de Candelaria — Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain (Recruiting)
- Hospital Virgen del Rocio — Seville, Sevilla, Spain (Recruiting)
- Hospital Universitario Y Politécnico La Fe — Valencia, Valencia, Spain (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Valladolid, Spain (Recruiting)
- Complexo Hospitalario Universitario De Vigo — Vigo, Vigo, Spain (Recruiting)
Study contacts
- Study coordinator: Eva Pereira
- Email: gecp@gecp.org
- Phone: +34934302006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.