Étude de phase Ib sur l'innocuité du T-DXd et du durvalumab avec chimiothérapie dans le CPNPC non épidermoïde HER2+ avancé ou métastatique

Essai clinique

Type : Industriel
Statut : Ouvert
Phase : I
Date d'ouverture : 09/03/2021
Date clôture : 26/09/2024
Promoteur : AstraZeneca
Progression du cancer: Loco-régional et à distance
Résumé :

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with durvalumab and chemotherapy in patients with HER2 positive advanced and metastatic non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Domaines/spécialités :
  • Cancers thoraciques respiratoires
    • Cancer bronchique non à petites cellules
Biomarqueurs :
  • HER2
Pathologies :
  • Tumeur maligne des bronches et du poumon - Cim10 : C34
Liens externes :

Critères de population

Sexe : Homme et femme
Age minimum : 18 ans
Age maximum : 120
Critères d’inclusion :
  • Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC
  • Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.
  • Part 2: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.
  • Part 2: Patients must have tumors that lack activating EGFR mutations, EML4-ALK fusion or other targetable alterations. Prior adjuvant, neoadjuvant therapies are permitted if progression has occurred > 12 months from the end of last therapy
  • HER2+ (IHC 3+ or IHC 2+) status as determined by central review of tumor tissue
  • WHO / ECOG performance status of 0 or 1
  • Measurable target disease assessed by the investigator using RECIST 1.1
  • Has protocol defined adequate organ and bone marrow function
Critères d’exclusion :
  • HER2 mutation if previously known
  • Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy
  • Active primary immunodeficiency known HIV infection, or active hepatitis B or C infection
  • Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
  • Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke
  • A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy)
  • Unresolved toxicities from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity.

Centre d'investigation

En cours
Nom : Centre Georges François Leclerc - CGFL
Ville : DIJON (21)
RESPONSABLE MÉDICAL
Nom : Pr GHIRINGHELLI
Prénom : François
Téléphone : Non disponible
Email : fghiringhelli@cgfl.fr
CONTACT TECHNIQUE
Nom : ERMAN
Prénom : Meryem
Téléphone : 03 80 73 75 00
Email : merman@cgfl.fr

Référentiels Oncologik

  • Cancer bronchique non à petites cellules