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Non Small Cell Lung CancerPhase 2ATHENEANCT07153445

Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)

A Phase 2 study testing Atezolizumab, Paclitaxel and Carboplatin in people with Non Small Cell Lung Cancer and Stage IIIA Lung Cancer, run by Fundación GECP at 21 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
21 sitesSpain
Study dates
8 Jul 2025to 2 May 2035
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

21 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Pereira contact

+34934302006

secretaria@gecp.org

21 sites in 1 country

Spain21 sites, 21 recruiting

  • Hospitalario Universitario A Coruña

    A Coruña, La Coruña, 15006

    Rosario García Campelo, MD

    Rosario García Campelo, MD

    Recruiting

  • Hospital General Universitario Dr. Balmis de Alicante

    Alicante, Alicante, 03010

    Bartomeu Massuti, MD

    Bartomeu Massuti, MD

    Recruiting

  • ICO Badalona, Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

    Enric Carcereny, MD

    Enric Carcereny, MD

    Recruiting

  • Hospital Universitari Vall d' Hebron

    Barcelona, Barcelona, 08035

    Alex Martínez, MD

    Alex Martínez, MD

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

    Sergio Martínez Recio, MD

    Sergio Martínez Recio, MD

    Recruiting

  • Hospital Parc Taulí

    Barcelona, Barcelona, 08208

    Laia Vilà, MD

    Laia Vilà, MD

    Recruiting

  • Hospital De Basurto

    Bilbao, Bilbao, 48013

    Mª Ángeles Sala, MD

    Mª Ángeles Sala, MD

    Recruiting

  • ICO Girona, Hospital Josep Trueta

    Girona, Girona, 17007

    Elia Sais, MD

    Elia Sais, MD

    Recruiting

  • Hospital Universitario Clinico San Cecilio

    Granada, Granada, 18007

    Silvia Sequero López, MD

    Silvia Sequero López, MD

    Recruiting

  • Hospital Univ. De Jerez De La Frontera

    Jerez de la Frontera, Cadiz, 11407

    Mª Angeles Moreno, MD

    Mª Angeles Moreno, MD

    Recruiting

  • Hospital Universitari de Gran Canària Doctor Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010

    David Aguiar Bujanda, MD

    David Aguiar Bujanda

    Recruiting

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

    Begoña Campos, MD

    Begoña Campos, MD

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Madrid, 28040

    Manuel Dómine, MD

    Manuel Dómine, MD

    Not yet recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

    Mariano Provencio, MD

    Clara Salas, MD

    Recruiting

  • Hospital Universitari Son Llatzer

    Palma de Mallorca, Palma de Mallorca, 07198

    Ester Gost, MD

    Juan Coves Sarto, MD

    Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona, Pamplona, 31008

    Maite Martínez, MD

    Maite Martínez, MD

    Recruiting

  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona, 43204

    Clara Lucía Gozalvez, MD

    Clara Lucía Gozalvez, Md

    Recruiting

  • Hospital Universitario Salamanca

    Salamanca, Salamanca, 37007

    Alejandro Olivares Hernández, MD

    Alejandro Olivares Hernández, MD

    Recruiting

  • Hospital Universitario Nuestra Señora La Candelaria

    Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38009

    Karla Mercedes Medina, MD

    Karla Mercedes Medina, MD

    Recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013

    Reyes Bernabé, MD

    Reyes Bernabé, MD

    Recruiting

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014

    Paula Espinosa, MD

    Paula Espinosa, MD

    Recruiting

Other trials in Spain

About this study

Official title: 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

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.

Read the 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 treatment all patients 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 study is an open-label, phase II, multicenter clinical trial for previously untreated adult patients with stage to IIIA and IIIB non-small cell lung cancer.

The primary objective is to evaluate the Progression free survival (PFS) in the intent-to-treat population.

Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death.

The total trial duration will be 10 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded.

Keywords
Non small cell lung cancer, Atezolizumab, Non-resected lung cancer, Adjuvant treatment
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    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.

  • PaclitaxelDrug

    Also called Taxol

    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.

  • CarboplatinDrug

    Also called Paraplatin

    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.

Study groups in NCT07153445
Study groupRoleWhat they receive
Experimental: Neoadjuvant/Induction treatmentExperimentalNeoadjuvant/Induction treatment prior to surgery: * Atezolizumab * Paclitaxel: * Carboplatin After assessment by a multidisciplinary team who will decide on the best post-induction treatment
Receives: Drug: Atezolizumab; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: From the date of randomization until end of follow up, up to 60 months.

Secondary outcomes (3)

  1. Resectability rate (%)

    Resectability rate defined as the percentage of patients resected divided by the total number of patients who received neoadjuvant treatment.

    Measured: From the date of randomization until end of follow up, up to 60 months.

  2. Pathological complete response (pCR)

    Pathological complete response (pCR) is defined as the absence of residual viable tumor on hematoxylin and eosin evaluation of the complete resected specimen

    Measured: From the date of randomization until end of surgery, up to 6 months

  3. Overall survival (OS)

    Overall survival (OS) defined as the time which begins at the start of treatment and up to the time of death or last follow up

    Measured: From the date of randomization until end of follow up, up to 60 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start8 Jul 2025
  3. Primary completion2 May 2035 (estimated)
  4. Study completion2 May 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
97 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07153445
Sponsor's protocol ID
GECP 23/02_ATHENEA
Other IDs
2024-515984-68-00
Acronym
ATHENEA
Status last verified
Nov 2025
First submitted
24 Jul 2025
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Paclitaxel and Carboplatin in people with Non Small Cell Lung Cancer and Stage IIIA Lung Cancer, run by Fundación GECP at 21 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Pereira (+34934302006, secretaria@gecp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: From the date of randomization until end of follow up, up to 60 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07153445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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