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

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

Phase 2 Interventional Fundación GECP · NCT07153445

This trial tests whether giving atezolizumab with carboplatin and paclitaxel before possible surgery, then continuing atezolizumab afterward, helps people with stage III non-small cell lung cancer stay free of disease progression longer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment97 (estimated)
Ages18 Years and up
SexAll
SponsorFundación GECP Academic / other
Drugs / interventionsatezolizumab
Locations21 sites (Alicante, Alicante and 20 other locations)
Trial IDNCT07153445 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 with previously untreated stage IIIA–IIIB NSCLC, no distant metastases, ECOG performance status 0–1, and adequate organ and lung function are the intended candidates.

Not a fit: Patients with distant metastatic disease, poor performance status, inadequate organ or lung function, or inability to tolerate platinum-based chemotherapy are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could prolong the time patients live without their cancer worsening and increase the chance that some can have curative surgery.

How similar studies have performed: Other trials combining PD-1/PD-L1 inhibitors with chemotherapy in the perioperative setting have produced promising pathologic responses and disease-free survival signals, though long-term survival benefits are still being established.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Alicante, Alicante and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Small Cell Lung CancerStage IIIA Lung CancerStage IIIB Lung CancerNon small cell lung cancerAtezolizumabNon-resected lung cancerAdjuvant treatment
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.