Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)
Recruiting · NCT07153445 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
21 locations listed.
- 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