NCT07153445 Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)
| NCT ID | NCT07153445 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fundación GECP |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 97 participants |
| Start Date | 2025-07-08 |
| Primary Completion | 2035-05-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 97 participants in total. It began in 2025-07-08 with a primary completion date of 2035-05-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Mariano Provencio, MD
STUDY CHAIR
President of Grupo Español de Cáncer de Pulmón
Frequently Asked Questions
Who can join the NCT07153445 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07153445 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07153445 currently recruiting?
Yes, NCT07153445 is actively recruiting participants. Contact the research team at secretaria@gecp.org for enrollment information.
Where is the NCT07153445 trial being conducted?
This trial is being conducted at Alicante, Spain, Badalona, Spain, Barcelona, Spain, Barcelona, Spain and 11 additional locations.
Who is sponsoring the NCT07153445 clinical trial?
NCT07153445 is sponsored by Fundación GECP. The principal investigator is Mariano Provencio, MD at President of Grupo Español de Cáncer de Pulmón. The trial plans to enroll 97 participants.
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