A phase III clinical trial of adjuvant chemotherapy versus chemoimmunotherapy for stage IB-IIIA completely resected non-small cell lung cancer (NSCLC) patients nadim-adjuvant: New adjuvant trial of chemotherapy versus chemoimmunotherapy.

Authors

null

Virginia Calvo

Instituto Investigacion Sanitaria Puerta de Hierro-Segovia de Arana, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain

Virginia Calvo , Manuel Domine , Ivana Sullivan , Jose-Luis Gonzalez-Larriba , Ana Laura Ortega , Reyes Bernabé , Maria Angeles Sala , Begona Campos , Javier De Castro , Paloma Martín-Martorell , Joaquim Bosch-Barrera , Xabier Mielgo , Laia Vilà , Joaquin Casal , Silver Ros , Maite Martinez Aguillo , Airam Padilla , Sergio Sandiego , Jonathan Aires Machado , Mariano Provencio-Pulla

Organizations

Instituto Investigacion Sanitaria Puerta de Hierro-Segovia de Arana, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain, Instituto de Investigación Sanitaria, Hospital Fundación Jiménez Díaz, Madrid, Spain, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, Hospital Clinico San Carlos, Madrid, Spain, Complejo Hospitalario de Jaén, Jaén, Spain, Hospital Universitario Virgen del Rocío, Seville, Spain, Hospital Universitario de Basurto, Bilbao, Spain, Hospital Universitario Lucus Augusti, Lugo, Spain, Translational Oncology Unit at Medical Oncology Division, Hospital Universitario La Paz, IdipAZ, Madrid, Spain, Hospital Clinic Universitario de Valencia, Valencia, Spain, Medical Oncology Department, Catalan Institute of Oncology, Girona, Spain, Hospital Universitario Fundación Alcorcón, Alcorcón, Spain, Parc Taulí University Hospital, Parc Taulí Institute of Research and Innovation I3PT, Barcelona Autonomous University, Spain, Sabadell, Spain, Hospital Alvaro Cunqueiro de Vigo, Vigo, Spain, Hospital Clinico Universitario Virgen de la Arrixaca, Murcia, Spain, Complejo Hospitalario De Navarra, Pamplona, Spain, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain, IVO, Valencia, Spain, Department of Clinical Oncology, University Hospital San Pedro de Alcántara, Cáceres, Spain

Research Funding

Pharmaceutical/Biotech Company
BMS

Background: The results of current studies are considered acceptable evidence to support the hypothesis of efficacy of the proposed combination of immunotherapy with chemotherapy (CT-IO) in patients with NSCLC stages Ib-IIIA candidates for adjuvant treatment. Methods: This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial. Primary objective and endpoint: The primary objective is disease free survival (DFS) defined time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time Sample size: 210 patients NSCLC stages Ib-IIIA (Experimental Arm (Adjuvant Chemotherapy-Inmunotherapy + maintenance adjuvant Inmunotherapy): 105 patients, Control Arm (Adjuvant Chemotherapy): 105 patients Treatment Patients randomised to the experimental arm will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC5 for 4 cycles every 21 days (+/- 3 days) as adjuvant treatment followed by maintenance adjuvant treatment for 6 cycles with Nivolumab 480 mg Q4W (+/- 3 days). Patients randomized to the control arm will receive Paclitaxel 200mg/m2 + Carboplatin AUC5 for 4 cycles every 21 days (+/- 3 days) followed by 2 observation visits. Total trial duration: 6.5 years, 3.5 years of recruitment, 1 year of adjuvant treatment or observation and 2 years of follow up. The start date was January 2021. The estimated primary completion date is June 2027. Clinical trial information: NCT04564157

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Adjuvant Therapy

Clinical Trial Registration Number

NCT04564157

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr TPS8581)

DOI

10.1200/JCO.2021.39.15_suppl.TPS8581

Abstract #

TPS8581

Poster Bd #

Online Only

Abstract Disclosures