Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)
NCT ID: NCT07153445
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
97 participants
INTERVENTIONAL
2025-07-08
2035-05-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer
NCT04832854
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT02367781
Atezolizumab Plus Induction Chemotherapy Plus CT-radiotherapy. (APOLO)
NCT04776447
New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy
NCT04564157
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
NCT02366143
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Depending on the decision each patient will be treated in a different way.
The study is an open-label, phase II, multicenter clinical trial for previously untreated adult patients with stage to IIIA and IIIB non-small cell lung cancer.
The primary objective is to evaluate the Progression free survival (PFS) in the intent-to-treat population.
Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death.
The total trial duration will be 10 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Neoadjuvant/Induction treatment
Neoadjuvant/Induction treatment prior to surgery:
* Atezolizumab
* Paclitaxel:
* Carboplatin
After assessment by a multidisciplinary team who will decide on the best post-induction treatment
Atezolizumab
Patients will receive atezolizumab administered by intravenous infusion in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
Paclitaxel
Neoadjuvant / induction treatment:
Atezolizumab Paclitaxel Carboplatin
Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery.
Route of administration Paclitaxel: Intravenous infusion.
Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Carboplatin
Neoadjuvant / induction treatment:
Atezolizumab Paclitaxel Carboplatin\*
\*Infusion according to the standard of each center
Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery.
Route of administration Carboplatin: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atezolizumab
Patients will receive atezolizumab administered by intravenous infusion in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
Paclitaxel
Neoadjuvant / induction treatment:
Atezolizumab Paclitaxel Carboplatin
Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery.
Route of administration Paclitaxel: Intravenous infusion.
Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
Carboplatin
Neoadjuvant / induction treatment:
Atezolizumab Paclitaxel Carboplatin\*
\*Infusion according to the standard of each center
Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery.
Route of administration Carboplatin: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
* 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
* Pleural or pericardial effusion
* 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.
* Symptomatic neuropathy grade \> 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
* Severe infections within 4 weeks prior to be included in the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación GECP
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mariano Provencio, MD
Role: STUDY_CHAIR
President of Grupo Español de Cáncer de Pulmón
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Parc Taulí
Barcelona, Barcelona, Spain
Hospital De Basurto
Bilbao, Bilbao, Spain
Hospital Univ. De Jerez De La Frontera
Jerez de la Frontera, Cadiz, Spain
ICO Girona, Hospital Josep Trueta
Girona, Girona, Spain
Hospital Universitario Clinico San Cecilio
Granada, Granada, Spain
Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Universitari de Gran Canària Doctor Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitari Son Llatzer
Palma de Mallorca, Palma de Mallorca, Spain
Complejo Hospitalario de Navarra
Pamplona, Pamplona, Spain
Hospital Universitario Salamanca
Salamanca, Salamanca, Spain
Hospital Universitario Nuestra Señora La Candelaria
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Del Rocio
Seville, Sevilla, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bartomeu Massuti, MD
Role: primary
Enric Carcereny, MD
Role: primary
Alex Martínez, MD
Role: primary
Sergio Martínez Recio, MD
Role: primary
Laia Vilà, MD
Role: primary
Mª Ángeles Sala, MD
Role: primary
Mª Angeles Moreno, MD
Role: primary
Elia Sais, MD
Role: primary
Silvia Sequero López, MD
Role: primary
Rosario García Campelo, MD
Role: primary
David Aguiar Bujanda, MD
Role: primary
Begoña Campos, MD
Role: primary
Manuel Dómine, MD
Role: primary
Mariano Provencio, MD
Role: primary
Ester Gost, MD
Role: primary
Maite Martínez, MD
Role: primary
Alejandro Olivares Hernández, MD
Role: primary
Karla Mercedes Medina, MD
Role: primary
Reyes Bernabé, MD
Role: primary
Clara Lucía Gozalvez, MD
Role: primary
Paula Espinosa, MD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Description Web page of the sponsor where users can find more information about Fundación GECP studies
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-515984-68-00
Identifier Type: CTIS
Identifier Source: secondary_id
GECP 23/02_ATHENEA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.