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. 2025 Nov:209:108763.
doi: 10.1016/j.lungcan.2025.108763. Epub 2025 Sep 24.

Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial

Dolores Isla  1 , Jon Zugazagoitia  2 , Edurne Arriola  3 , Rosario García-Campelo  4 , Cristina Martí Blanco  5 , María Pilar Diz-Taín  6 , Marta López-Brea  7 , Alberto Luis Moreno-Vega  8 , Luis León-Mateos  9 , Juana Oramás  10 , Vanesa Gutiérrez-Calderón  11 , Margarita Majem  12 , Alfredo Sánchez-Hernández  13 , Carlos Aguado  14 , Ruth Alvarez-Cabellos  15 , Bartomeu Massutí  16 , Amaia Moreno  17 , José-Luis Fírvida-Pérez  18 , Javier Valdivia  19 , Marta González-Cordero  20 , Marta Zafra-Poves  21 , Manuel Dómine  22 , Francisco Javier Garcia-Navalon  23 , Noemí Villanueva  24 , Mariano Provencio  25 , Oscar Juan-Vidal  26 , Carlos Rivas-Corredor  27 , María Eugenia Olmedo García  28 , Ramón Palmero  29 , Rafael López-Castro  30 , Enric Carcereny  31 , José Luis Lechuga  32 , Marta Domínguez  32 , Ángel Callejo  32 , Luis Paz-Ares  33
Affiliations
Free article

Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial

Dolores Isla et al. Lung Cancer. 2025 Nov.
Free article

Abstract

Background: Immunotherapy trials involving patients with extensive-stage small cell lung cancer (ES-SCLC) from real-world clinical practice are needed. We aimed to evaluate the safety and effectiveness of durvalumab plus platinum-etoposide as a first-line treatment in a real-world population of patients with ES-SCLC.

Patients and methods: A prospective, single-arm study was conducted in adult patients who had histologically or cytologically confirmed ES-SCLC and a WHO/ECOG PS of 0-2 (a maximum of 30 % of patients with a PS of 2 were allowed). Patients received durvalumab plus platinum-etoposide for up to 6 cycles, followed by durvalumab every 4 weeks as a single agent. The primary outcomes included the incidence of grade ≥ 3 adverse events (AEs) and immune-mediated AEs (imAEs).

Results: Between December 2020 and April 2021, 101 patients were included in this trial. Grade 3 or higher AEs occurred in 77 patients (76.2 %) and were considered treatment-related in 58 patients (57.4 %). Thirty-eight patients (37.6 %) reported at least one imAE, all of which were considered treatment related. Among the 82 imAEs reported during the study, 68 (82.9 %) were grade 1-2. The median overall survival was 9.6 months (95 % CI, 7.8 to 11.3), and the 12-month and 24-month overall survival rates were 40.7 % (31.1 % to 50.3 %) and 25.4 % (95 % CI, 16.8 % to 34.0 %), respectively.

Conclusions: This phase 3B trial suggests that first-line treatment of patients with ES-SCLC with an initial regimen of up to six cycles of durvalumab plus platinum-etoposide followed by maintenance with durvalumab is feasible providing more options in daily clinical practice for the management of these patients depending on their characteristics..

Trial registration: NCT04712903.

Keywords: Adverse events; Durvalumab; Extensive-stage small cell lung cancer; Immune-mediated adverse events; Real-world.

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Conflict of interest statement

Declaration of competing interest Dolores Isla has been advisory board member for Amgen, AstraZeneca, Bayer, BMS, Beigene, Boehringer Ingelheim, F. Hoffmann-La Roche, Johnson & Johnson, Lilly, Merck, MSD, Pfizer, Pharmamar, Sanofi, Takeda; has received speaker honorarium from Amgen, AstraZeneca, Bayer, BMS, F. Hoffmann-La Roche, Johnson & Johnson, Lilly, MSD, Pfizer, Pharmamar; has received research grants from AstraZeneca, BMS, F. Hoffmann-La Roche, GSK; has received consulting honorarium from Amgen, AstraZeneca, Bayer, BMS, Beigene, Boehringer Ingelheim, F. Hoffmann-La Roche, Johnson & Johnson, Lilly, Merck, MSD, Pfizer, Pharmamar; and has received travel grants from Amgen, AstraZeneca, BMS, F. Hoffmann-La Roche, Johnson & Johnson, MSD, Pfizer. Jon Zugazagoitia reports speakers’, advisory or travel honoraria from Boehringer Ingelheim, Janssen, Pierre Fabre, Takeda, Sanofi, BMS, AstraZeneca, MSD, Roche, Pfizer, Novartis, and NanoString; and research support/grants from AstraZeneca, Roche, and BMS. Edurne Arriola has been advisory board member for Lilly, Roche, Boehringer, Pfizer and Sanofi; has received speaker honorarium from Lilly, Astra Zeneca, Roche, Takeda, MSD, Pfizer, Janssen, and BMS; has received research grants to institution from Astra Zeneca and BMS; and has received travel grants from Astra Zeneca, Roche, and Pfizer. Rosario García Campelo reports consultant fees from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, F. Hoffmann-La Roche, Janssen, Lilly, MSD, Pfizer, Sanofi, Takeda, Pfizer; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, F. Hoffmann-La Roche, Janssen, Lilly, MSD, Pfizer, Sanofi, Takeda, Pfizer; and support for attending meetings and/or travel from Roche, Janssen, Pfizer, AZ, MSD. Cristina Martí Blanco has received speaker honorarium from Astra-Zeneca, Pfizer, BMS; and has received travel grants from Merck, MSD, BMS and Roche. María Pilar Diz Taín, has been advisory board member for Boehringer Ingelheim, BMS, AstraZeneca; has received speaker honorarium from BMS, AstraZeneca, Roche, MSD, Takeda, Pfizer, Amgen; has received research grants to institution from AstraZeneca, Roche, Mirati, Pfizer; has received research grants from AstraZeneca, Roche, Pfizer; has received advisory honorarium from Boehringer Ingelheim, BMS, AstraZeneca; and has received travel grants from BMS, Roche, MSD, Takeda. Marta López-Brea has received speaker honorarium from Roche, Astra, MSD, Pfizer and Taked has received advisory honorarium from Roche, Takeda, BMS; and has received travel grants from Pfizer. Alberto Luis Moreno-Vega has received speaker honorarium from Pharmamar and has received travel grants from Novartis, Lilly, Pfizer, MSD. Luis León-Mateos reports consulting fees from AstraZeneca, Bristol Myers Squib, Merck, MSD, Roche, Sanofi, and Takeda; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Bristol Myers Squib, Jansen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, and Takeda; and support for attending meetings and/or travel from AstraZeneca, Bristol Myers Squib, Jansen, MSD, Pfizer, Roche, Sanofi, and Takeda. Juana Oramas has received speaker honorarium from GSK, Roche, AZ; and has received travel grants from Roche, Pfizer. Vanesa Gutiérrez Calderón reports no conflict of interest. Margarita Majem reports advisory Board or consulting fees: AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Helsinn Therapeutics, Eli Lilly, MSD, Novartis, Pfizer, F. Hoffmann-La Roche Ltd., Takeda, Sanofi, Janssen, Amgen, Cassen Recordatti, Beigene, Regeneron; research funding (institution): Bristol-Myers Squibb, AstraZeneca, F. Hoffmann-La Roche Ltd; travel and accommodation support: AstraZeneca, F. Hoffmann-La Roche Ltd., Pfizer, MSD. Alfredo Sanchez-Hernandez has received speaker honorarium from Pfizer, Roche, Regeneron, BMS, Takeda, MSD, Astra-Zeneca, Amgen; and has received travel grants from Pfizer, Bayer, Takeda, Roche, Merck, Takeda, MSD. Carlos Aguado has been advisory board member for MSD, ROCHE, ASTRA ZENECA, TAKEDA; has received speaker honorarium from BMS, PIERRE FABRE; has received research grants from AMGEN, MSD, ASTRA ZENECA, LILLY, BMS; and has received travel grants from PIERRE FABRE, MSD. Ruth Alvarez Cabellos reports no conflict of interest. Bartomeu Massutí reports the following financial interest: Astra Zeneca, Advisory Board, Personal; BMS, Advisory Board, Personal; Boehringer Ingelheim, Advisory Board, Personal; MSD, Invited Speaker, Personal; Roche, Invited Speaker, Personal; BMS, Funding, Institutional, Financial interest, Research on Tumor Board. He also reports the following non financial interest from Astra Zeneca, Principal Investigator MSD, Principal Investigator; ASCO, Affiliate; IASLC, Member; SEOM, Member; SLCG, Leadership Role. Amaia Moreno Paul reports no conflict of interest. Jose Luis Firvida Perez has received speaker honorarium from AMGEN, ASTRA ZENECA, BEIGENE, BMS, LILLY, MSD, PFIZER, PIERRE FABRE, ROCHE and TAKEDA. Javier Valdivia has received speaker honorarium from AstraZeneca, Roche, and Sun Pharma; and has received travel grants from Pierre Fabre. Marta González-Cordero has not been advisory board member; has received speaker honorarium from Astellas Pharma, Amgen, MSD Oncology, Bayer, Roche and Merck; has not received research grants to institution; has not received research grants; has not received consulting honorarium; has received advisory honorarium from for MSD Oncology and AstraZeneca Spain and has received travel grants from Roche, Merck, Janssen Oncology, Bayer. Marta Zafra reports no conflict of interest. Manuel Dómine reports consulting fees from Astra Zeneca, Bristol-Myers Squibb, MSD Oncology, Pharmamar, Pfizer, Roche, Takeda; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astra Zeneca, Bristol-Myers Squibb, MSD Oncology, Pfizer, Roche, Takeda; support for attending meetings and/or travel from Astra Zeneca, MSD Oncology, Pfizer, Takeda. Francisco Javier Garcia-Navalon reports no conflicto of interests. Noemí Villanueva has received speaker honorarium from Astra Zeneca, Pfyzer and Janssen-Cilag. Mariano Provencio reports grants or contracts from any entity Research funding received from BMS, AstraZeneca, MSD, Roche, Takeda, Pfizer, Takeda, Boehringer Ingelheim, Amgen, Instituto de Salud Carlos III, Spanish Ministry of Science and Innovation, European Commission, Eli Lilly, F. Hoffman-La Roche, Janssen, Phierre Fabre Pharmaceuticals; Consulting fees from BMS, Astra Zeneca, MSD, Roche, Takeda, Eli Lilly, F. Hoffman-La Roche, Janssen, Pfizer, Amgen; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from BMS, Astra Zeneca, MSD, Roche, Takeda, Eli Lilly, F. Hoffman-La Roche, Janssen, Pfizer, Amgen; support for attending meetings and/or travel from BMS, Astra Zeneca, MSD, Roche, Takeda, Eli Lilly, F. Hoffman-La Roche, Janssen, Pfizer, Amgen, Boehringer Ingelheim. Pierre Fabre Pharmaceuticals, Janssen; participation on a Data Safety Monitoring Board or Advisory Board Advisory Board from Amgen, Pfizer, Daiichi Sankyo, Johnson & Johnson, BMS, Takeda, AstraZeneca, Gilead, MSD, Guardant Health, Ipsen, Incyte Biosciences, Bayer, Pharmacosmos, Janssen, Astellas Pharma, Aegean Pharmaceuticals. Board of Directors: Instituto Investigación Sanitaria Puerta de Hierro − Segovia de Arana Grupo Español de Cáncer de Pulmón (Grupo Espñaol de Cáncer de Pulmón) Grupo Oncológico para el Tratamiento de las Enfermedades Linfoides (Spanish Lymphoma Oncology Group). Oscar Juan-Vidal reports honoraria or Advisory role: Bristol-Myers Squibb, Roche/Genentech, AstraZeneca, Pfizer, Eli Lilly, Takeda, Janssen, Novartis; Travel, accommodations, expenses: Takeda, Astra-Zeneca, Roche/Genentech, Pfizer, Merck Sharp & Dohme, Roche/Genentech. Carlos Rivas Corredor declares no conflict of interest. María Eugenia Olmedo García has been advisory board member for AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Daiichi Sankyo, GlaxoSmithKline, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi and Takeda; has received speaker honorarium from AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, MSD, Pfizer, Roche, Sanofi and Takeda; and has received travel grants from AbbVie, Amgen, AstraZeneca, Daiichi Sankyo, Janssen, Lilly, MSD, Pfizer, Roche, and Takeda. Ramón Palmero has received speaker honorarium from Guardant health and Pfizer; has received consulting honorarium from AstraZeneca; has received advisory honorarium from AstraZeneca; and has received travel grants from Merck Sharp and Dohme. Rafael López-Castro has been advisory honorarium from Amgen, GSK, Roche, MSD and BMS; has received consulting honorarium from AstraZeneca and Roche; and has received travel grants from Takeda, Roche and MSD. Enric Carcereny has been advisory board member for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, MSD, Novartis, Roche, Takeda; has received speaker honorarium from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, MSD, Novartis, Pfizer, Roche, Takeda, Pierre-Fabre; and has received travel grants from Bristol-Myers Squibb, Pfizer, Roche, Takeda, AstraZeneca. José Luis Lechuga is full time employee of AstraZeneca Farmacéutica Spain, S.A. (Madrid, Spain). Marta Domínguez is full time employee of AstraZeneca Farmacéutica Spain, S.A. (Madrid, Spain). Ángel Callejo is full time employee of AstraZeneca Farmacéutica Spain, S.A. (Madrid, Spain). Luis Paz-Ares, Head of Oncology Department at Hospital 12 de Octubre in Madrid, Spain, has been advisory board member for: has received speaker honorarium from: Abbvie, Amgen, Astrazeneca, Bayer, Beigene (BeOne Medicines I GmbH now), Biontech, BMS, Boehringer, Daichii, Gilead, GSK, Itheos Pharmaceuticals, Lilly, Merck, MSD, Novartis, Ottimopharma, Pharmamar, Pfizer, Pierre Fabre, Regeneron, Roche); has received research grants to institution from BMS, Lilly, Pharmamar, Roche; has Board member: Altum sequency, Stab Therapeutics.

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