Neoadjuvant atezolizumab with carboplatin and paclitaxel followed by atezolizumab maintenance for Stage III non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ATHENEA is an open-label, multicenter phase II trial enrolling 97 adults with previously untreated stage IIIA or IIIB non-small cell lung cancer. Participants receive three cycles of atezolizumab combined with paclitaxel and carboplatin as neoadjuvant/induction therapy, after which a multidisciplinary team decides whether a patient proceeds to surgery. Following that decision, patients receive different post-induction treatments and enter long-term follow-up, with progression-free survival as the primary endpoint. The planned overall timeline is about 10 years including treatment, five years of follow-up, and study close-out.

Why it matters

Who can join: the full rules

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's running

• Hospital General Universitario Dr. Balmis de Alicante
  Alicante, Alicante, Spain Recruiting
• ICO Badalona, Hospital Germans Trias i Pujol
  Badalona, Barcelona, Spain Recruiting
• Hospital Universitari Vall d' Hebron
  Barcelona, Barcelona, Spain Recruiting
• Hospital de la Santa Creu i Sant Pau
  Barcelona, Barcelona, Spain Recruiting
• Hospital Parc Taulí
  Barcelona, Barcelona, Spain Recruiting
• Hospital De Basurto
  Bilbao, Bilbao, Spain Recruiting

Study contacts

• Study coordinator: Eva Pereira
• Email: secretaria@gecp.org
• Phone: +34934302006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.