Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)

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

Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC) (NCT07153445) is a Phase 2 interventional studying Non Small Cell Lung Cancer and Stage IIIA Lung Cancer, sponsored by Fundación GECP. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Non Small Cell Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 97 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Non Small Cell Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene. - 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 conditions (where your immune system attacks your own body) or lung disease ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Criteria: * Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene. * 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

Treatments Being Tested

DRUG

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.

DRUG

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.

DRUG

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.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07153445), the sponsor (Fundación GECP), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07153445 clinical trial studying?

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 w… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07153445?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07153445?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07153445. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07153445. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.