Status:
RECRUITING
Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)
Lead Sponsor:
Fundación GECP
Conditions:
Non Small Cell Lung Cancer
Stage IIIA Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 + Carboplati...
Detailed Description
The study ATHENEA is a phase II clinical trial intending to enroll 97 patients, who will receive Atezolizumab + Paclitaxel + Carboplatin as induction/neoadjuvant treatment. After the induction treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 2 2035
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT07153445
Start Date
July 8 2025
End Date
May 2 2035
Last Update
November 19 2025
Active Locations (21)
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1
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, Spain, 03010
2
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Hospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain, 08035
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08041