Tests atezolizumab with chemotherapy before surgery in lung cancer
Tests atezolizumab with chemotherapy in adults with stage IIIA or IIIB lung cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)
Key facts
- Where
- A Coruña, Alicante, Badalona, Barcelona, Bilbao, Girona, Granada, Jerez de la Frontera, Las Palmas De Gran Canaria, Lugo, Madrid, Majadahonda, Palma, Pamplona, Reus, Sabadell, Salamanca, Santa Cruz de Tenerife, Sevilla, and Valencia, SpainSee the 21 sites
- Phase
- Phase 2
Where in Spain
- Complexo Hospitalario Universitario A CoruñaA Coruña, SpainTaking people
- Hospital General Universitario Dr. BalmisAlicante, SpainTaking people
- Institut Catala d'OncologiaBadalona, SpainTaking people
- Hospital de la Santa Creu i Sant PauBarcelona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Universitario BasurtoBilbao, SpainTaking people
- Institut Català d'OncologiaGirona, SpainTaking people
- Hospital Universitario Clínico San CecilioGranada, SpainTaking people
- Hospital de Jerez de la FronteraJerez de la Frontera, SpainTaking people
- El Hospital Universitario De Gran Canaria Dr. NegrinLas Palmas De Gran Canaria, SpainTaking people
- Hospital Universitario Lucus AugustiLugo, SpainTaking people
- Hospital Universitario Fundación Jiménez DíazMadrid, SpainTaking people
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpainTaking people
- Hospital Son LlatzerPalma, SpainTaking people
- Hospital Universitario de NavarraPamplona, SpainTaking people
- Salut Sant Joan de ReusReus, SpainTaking people
- Parc Tauli Hospital UniversitariSabadell, SpainTaking people
- Hospital Universitario De SalamancaSalamanca, SpainTaking people
- Hospital Universitario Nuestra Señora de CandelariaSanta Cruz de Tenerife, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital General Universitario de ValenciaValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación GECP
- Trial code
- NCT07153445EU 2024-515984-68-00
- Record updated
- 19 November 2025
- Original description
This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled.Read full original descriptionShow less
Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy
This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled.
The treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant/induction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not.
Depending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.
Inclusion: Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology); Confirm the absence of distant disease; ECOG (Performance status) 0-1; Adequate hematologic and organ function; All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention; Adequate lung function; Patients aged > 18 years; For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception; For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception; Oral contraception should always be combined with an additional contraceptive method; Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug; Patient capable of proper therapeutic compliance and accessible for correct follow-up.
Exclusion: Weight loss >10% within the previous 3 months; Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer; Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment; Severe infections within 4 weeks prior to be included in the study; Known hypersensitivity or allergy to atezolizumab formulation; History of autoimmune disease or lung disease; Positive test for human immunodeficiency viruses (HIV); Patients with active hepatitis B or hepatitis C or psitive for hepatitis C virus; Active tuberculosis; Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene; Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations; Pleural or pericardial effusion; Symptomatic neuropathy grade > 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.