Etude : TAK-788-3001 /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : TAK-788-3001

Nom :

Traitement : Métastatique ou localement avancé

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 28/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The drug being tested in this study is called TAK-788. TAK-788 is being tested to evaluate the efficacy as a first line treatment compare with platinum-based chemotherapy in the participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor 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

The participants will be administered with TAK-788 orally in arm A and Pemetrexed/Cisplatin or Pemetrexed/Carboplatin intravenously (IV) in arm B until the participants experience progressive disease (PD) as assessed by blinded independent review committee (IRC), intolerable toxicity or another discontinuation criteria. Participants in the chemotherapy group may cross over to treatment with TAK-788 after IRC-assessed PD is documented. Randomized treatment with TAK-788 or platinum-based chemotherapy may be continued after PD, at the discretion of the investigator and with the sponsor's approval, if there is still evidence of clinical benefit.


Current primary outcome:
Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
PFS is defined as the time interval from the date of randomization until the first date at which the criteria for PD according to RECIST version 1.1 are met or death, whichever occurs first.

Current secondary outcomes:
- Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1 [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Overall Survival (OS) [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Progression Free Survival (PFS) as Assessed by the Investigator [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Confirmed Objective Response Rate (ORR) as Assessed by the Investigator [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 [ Time Frame: Up to approximately 40 months after the first participant is randomized ]
- Participant-reported Symptoms as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13) [ Time Frame: Up to approximately 40 months after the first participant is randomized ]

Phase : III

Stade : Localement avancé à Métastasique

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 : - 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 : - 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
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 Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Alexis Cortot

TEC / ARC / IDE :
Eric Wasielewski
eric.wasielewski@
chru-lille.fr
03.20.44.56.12

Statut de l'essai : À VENIR

MAJ : 14/01/2020