Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07153445

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

Led by Fundación GECP · Updated on 2025-11-19

97

Participants Needed

21

Research Sites

512 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Previously untreated patients with stage IIIA or IIIB non-small cell lung cancer confirmed by biopsy
  • No distant spread of the cancer
  • Performance status of 0 or 1 on the ECOG scale
  • Adequate blood counts and organ function
  • Signed informed consent according to guidelines
  • Adequate lung function
  • Age over 18 years
  • Agreement to use highly effective contraception if of childbearing potential
  • Negative pregnancy test for women not postmenopausal or surgically sterile
  • Ability to comply with treatment and follow-up requirements
Not Eligible

You will not qualify if you...

  • Presence of mutations in the EGFR gene or ALK fusion oncogene
  • Known STK-11 ligand alterations, MDM2 amplifications, or ROS1 translocations
  • Weight loss greater than 10% in the last 3 months
  • Previous treatment with anti-cancer drugs, chest radiotherapy, or lung cancer surgery
  • Other cancers within 3 years before enrollment
  • Pleural or pericardial fluid buildup
  • Allergy to atezolizumab
  • History of autoimmune or lung diseases
  • Positive test for HIV
  • Active hepatitis B or C infection
  • Active tuberculosis
  • Symptomatic neuropathy grade higher than 1
  • Severe infections within 4 weeks before study entry

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 21 locations

1

Hospital General Universitario Dr. Balmis de Alicante

Alicante, Alicante, Spain, 03010

Actively Recruiting

2

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

3

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, Spain, 08035

Actively Recruiting

4

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain, 08041

Actively Recruiting

5

Hospital Parc Taulí

Barcelona, Barcelona, Spain, 08208

Actively Recruiting

6

Hospital De Basurto

Bilbao, Bilbao, Spain, 48013

Actively Recruiting

7

Hospital Univ. De Jerez De La Frontera

Jerez de la Frontera, Cadiz, Spain, 11407

Actively Recruiting

8

ICO Girona, Hospital Josep Trueta

Girona, Girona, Spain, 17007

Actively Recruiting

9

Hospital Universitario Clinico San Cecilio

Granada, Granada, Spain, 18007

Actively Recruiting

10

Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain, 15006

Actively Recruiting

11

Hospital Universitari de Gran Canària Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain, 35010

Actively Recruiting

12

Hospital Universitario Lucus Augusti

Lugo, Lugo, Spain, 27003

Actively Recruiting

13

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, Spain, 28040

Not Yet Recruiting

14

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain, 28222

Actively Recruiting

15

Hospital Universitari Son Llatzer

Palma de Mallorca, Palma de Mallorca, Spain, 07198

Actively Recruiting

16

Complejo Hospitalario de Navarra

Pamplona, Pamplona, Spain, 31008

Actively Recruiting

17

Hospital Universitario Salamanca

Salamanca, Salamanca, Spain, 37007

Actively Recruiting

18

Hospital Universitario Nuestra Señora La Candelaria

Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain, 38009

Actively Recruiting

19

Hospital Universitario Virgen Del Rocio

Seville, Sevilla, Spain, 41013

Actively Recruiting

20

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, Spain, 43204

Actively Recruiting

21

Hospital General Universitario de Valencia

Valencia, Valencia, Spain, 46014

Actively Recruiting

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Research Team

E

Eva Pereira

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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