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

NCT07153445 | Recruiting Phase 2 DMC

• 2 other identifiers: GECP 23/02_ATHENEA2024-515984-68-00
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 21

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 + 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

Non Small Cell Lung Cancer; Stage IIIA Lung Cancer; Stage IIIB Lung Cancer

Keywords

Non small cell lung cancer; Atezolizumab; Non-resected lung cancer; Adjuvant treatment

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• Resectability rate (%)

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

• Pathological complete response (pCR)

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

• Overall survival (OS)

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

Study Arms (1)

Experimental: Neoadjuvant/Induction treatment

EXPERIMENTAL

Neoadjuvant/Induction treatment prior to surgery: * Atezolizumab * Paclitaxel: * Carboplatin After assessment by a multidisciplinary team who will decide on the best post-induction treatment

Drug: Atezolizumab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Atezolizumab DRUG

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.

Also known as: Tecentriq

Experimental: Neoadjuvant/Induction treatment

Paclitaxel DRUG

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.

Also known as: Taxol

Experimental: Neoadjuvant/Induction treatment

Carboplatin DRUG

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.

Also known as: Paraplatin

Experimental: Neoadjuvant/Induction treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación GECP: lead

Study Sites (21)

Hospital General Universitario Dr. Balmis de Alicante

Alicante, Alicante, 03010, Spain

RECRUITING

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital Universitari Vall d' Hebron

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

RECRUITING

Hospital Parc Taulí

Barcelona, Barcelona, 08208, Spain

RECRUITING

Hospital De Basurto

Bilbao, Bilbao, 48013, Spain

RECRUITING

Hospital Univ. De Jerez De La Frontera

Jerez de la Frontera, Cadiz, 11407, Spain

RECRUITING

ICO Girona, Hospital Josep Trueta

Girona, Girona, 17007, Spain

RECRUITING

Hospital Universitario Clinico San Cecilio

Granada, Granada, 18007, Spain

RECRUITING

Hospitalario Universitario A Coruña

A Coruña, La Coruña, 15006, Spain

RECRUITING

Hospital Universitari de Gran Canària Doctor Negrín

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

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, Lugo, 27003, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz

Madrid, Madrid, 28040, Spain

NOT YET RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

RECRUITING

Hospital Universitari Son Llatzer

Palma de Mallorca, Palma de Mallorca, 07198, Spain

RECRUITING

Complejo Hospitalario de Navarra

Pamplona, Pamplona, 31008, Spain

RECRUITING

Hospital Universitario Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Nuestra Señora La Candelaria

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

RECRUITING

Hospital Universitario Virgen Del Rocio

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43204, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

Related Links

• Description Web page of the sponsor where users can find more information about Fundación GECP studies

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

atezolizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Mariano Provencio, MD

  President of Grupo Español de Cáncer de Pulmón

  STUDY CHAIR

Central Study Contacts

Eva Pereira

CONTACT

+34934302006; secretaria@gecp.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: September 4, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): May 2, 2035
• Study Completion (Estimated): May 2, 2035
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (21)