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

RecruitingPhase 2Ages 18 Years - anyAllFundación GECP
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Atezolizumab
  • Paclitaxel
  • Carboplatin
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Where

21 sites
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Spain
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Parc Taulí
Barcelona, Spain
Hospital De Basurto
Bilbao, Spain
Hospital Univ. De Jerez De La Frontera
Jerez de la Frontera, Spain
ICO Girona, Hospital Josep Trueta
Girona, Spain

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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