Etude : TAK-788-3001 / EXCLAIM 2



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : TAK-788-3001 / EXCLAIM 2

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 01/12/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude de phase 3, randomisée, multicentrique, en ouvert, visant à comparer l’efficacité du TAK-788 en traitement de première ligne par rapport à une chimiothérapie à base de platine chez des patients atteints d’un cancer du poumon non à petites cellules porteurs de mutations par insertion dans l’exon 20 du gène de l’EGFR

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The purpose of this study is to compare the efficacy of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

The study will enroll approximately 318 patients. Participants will be randomly assigned to one of the two treatment groups:

- TAK-788 group (Arm A):
TAK-788 160 mg, capsules, orally, once daily until the participants experience progressive disease (PD) as assessed by blinded independent review committee (IRC), intolerable toxicity, or another discontinuation criteria.

-Platinum-based chemotherapy group (Arm B):
Pemetrexed 500 mg/m^2 plus Cisplatin 75 mg/m^2, infusion, intravenously, once on Day 1 of 21-day cycle pemetrexed 500 mg/m^2 plus Carboplatin, infusion, intravenously, once at a dose calculated to produce area under curve (AUC) of 5 mg*min/mL on Day 1 of 21-day cycle until the participants experience PD as assessed by blinded IRC, intolerable toxicity, or another discontinuation criteria. Pemetrexed/Cisplatin or pemetrexed/Carboplatin will be repeated every 3 weeks for 4 cycles, followed by maintenance treatment with pemetrexed 500 mg/m^2, on Day 1 of a 21-day cycle thereafter.

Phase : III

Stade : Localement avancé à Métastatique

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : ATTENTION LISTE NON EXHAUSTIVE
- Histologically or cytologically confirmed locally advanced not suitable for definitive therapy, recurrent, or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
- Documented epithelial growth factor receptor (EGFR) in-frame exon 20 insertion mutation assessed by a clinical laboratory improvements amendment (CLIA)-certified (United States [US] sites) or an accredited (outside of the US) local laboratory. The EGFR exon 20 insertion mutation can be either alone or in combination with other EGFR or HER2 mutations except EGFR mutations for which there are approved anti-EGFR TKIs (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)
- Adequate tumor tissue available, either from primary or metastatic sites, for central laboratory confirmation of EGFR exon 20 insertion mutation
- At least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) version 1.1
- Life expectancy ≥3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Critères de non-inclusion : ATTENTION LISTE NON EXHAUSTIVE
- Received prior systemic treatment for locally advanced or metastatic disease
- Received radiotherapy ≤14 days before randomization or has not recovered from radiotherapy-related toxicities
- Received a moderate or strong cytochrome P-450 (CYP)3A inhibitor or moderate or strong CYP3A inducer within 10 days before randomization
- Have been diagnosed with another primary malignancy other than NSCLC
- Have current spinal cord compression or leptomeningeal disease
- Have uncontrolled hypertension. Participants with hypertension should be under treatment on study entry to control blood pressure
- Received a live vaccine within 4 weeks before randomization per Summary of product characteristics (SmPCs) for pemetrexed, cisplatin, and carboplatin
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04129502
Promoteur :
MILLENIUM PHARMACEUTICALS
Type de sponsor : Industriel
MILLENIUM PHARMACEUTICALS - MILLENIUM PHARMACEUTICALS
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Radj GERVAIS

TEC / ARC / IDE :
Karim HAMOND
k.hamond@
baclesse.unicancer.fr

Statut de l'essai : OUVERT

MAJ : 17/11/2021