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
Fundación GECP
97 participants
Jul 8, 2025
INTERVENTIONAL
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
Inclusion Criteria12
- 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 Criteria13
- 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
Interventions
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.
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.
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(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07153445