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TERMINATEDPHASE2

Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients

A Phase II Trial of Neoadjuvant Treatment Carboplatin-Pemetrexed-Bevacizumab Plus Atezolizumab for the Treatment of Locally Advanced and Potentially Resectable NSCLC Patients With EGFR Mutations

NCT04512430•Fundación GECP

View on ClinicalTrials.gov

Summary

This is an open-label, non-randomised, phase II, multi-centre clinical trial 26 patients will be enrolled in this trial to evaluate the major pathologic response in patients with neoadjuvant treatment with Carboplatin Pemetrexed Bevacizumab plus Atezolizumab in patients with non-small cell lung carcinoma locally advanced mutated in EGFR

Detailed Description

This is an open-label, non-randomised, phase II, multi-centre clinical trial. Patients enrolled will receive Atezolizumab 1200mg + Bevacizumab 15mg/Kg + Carboplatin AUC6 + Pemetrexed 500mg/m2 for 3 cycles every 21 days (+/- 3 days) as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Atezolizumab 1200 mg Q4W (+/- 3 days). The primary objective is to evaluate the major pathologic response defined as 10 percent or fewer viable cancer cells detectable in the resected tumor and in lymph nodes in stage IIIA EGFR mutated patients treated in neoadjuvant setting with atezolizumab- bevacizumab- carboplatin and pemetrexed. Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3-6 months. Treatment and follow-up are expected to extend the study duration to a total of 6 years. Patients will be followed 3 years after adjuvant treatment. The study will end once survival follow-up has concluded. This will be followed by a close out period of 4 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology). PET/CT including IV contrast (CT of diagnostic quality) will be performed at baseline (28 days +10 before randomization).
•2\. Tumor should be considered resectable before study entry by a multidisciplinary team
•3\. Sensitizing EGFR mutation (Del Exon 19 and ins Exon 21).
•4\. ECOG (Performance status) 0-1
•5\. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to randomization i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 ×109/L iii. Hemoglobin \> 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): a. Female CrCl = (140 - age in years) x weight in kg x 0.85/ 72 x serum creatinine in mg/dL b. Male CrCl = (140 - age in years) x weight in kg x 1.00/ 72 x serum creatinine in mg/dL v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) vii. PT/APTT/INR within normal limits
•6\. Measurable or evaluable disease according to RECIST v1.1.
•7\. The patients need to have a forced expiratory volume (FEV1)≥ 1.2 liters or \>40% p- predicted value.
•8\. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.
•9\. Patients aged \> 18 years.
•10\. Patient capable of proper therapeutic compliance and accessible for correct follow-up.
+4 more criteria

Exclusion Criteria

•1\. All patients carrying other EGFR mutations.
•2\. Patients with known anaplastic lymphoma kinase (ALK) fusion oncogene, STK11 ligand alteration or ROS1 translocations.
•3\. Clinically significant comorbidities that impaired administration of platinum-based chemotherapy.
•4\. Patients with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
•5\. Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
•6\. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy.
•7\. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
•8\. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
•9\. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
•10\. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
+15 more criteria

Locations (18)

ICO Badalona, Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

ICO Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Insular de Gran canaria

Las Palmas de Gran Canaria, Gran Canaria, Spain

Complejo Hospitalario de Navarra

Pamplona, Iruña, Spain

Hospitalario Universitario A Coruña

A Coruña, La Coruña, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Universitari Quiron Dexeus

Barcelona, Spain

Hospital Universitari Vall d' Hebron

Barcelona, Spain

ICO Girona, Hospital Josep Trueta

Girona, Spain

Key Dates

Start Date

December 2, 2020

Primary Completion Date

July 19, 2024

Completion Date

July 19, 2024

Last Updated

April 2, 2025

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung CancerEGFR Gene Mutation

Interventions

Atezolizumab

DRUG

Bevacizumab

DRUG

Carboplatin

DRUG

Pemetrexed

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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