TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

Titre officiel

A Randomized Phase 3 Multicentre Open-Label Study to Compare the Efficacy of TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

Sommaire:

L’objectif de cette étude est de comparer l’efficacité de TAK-788 comme traitement de première intention à celle d’une chimiothérapie à base de platine chez des participants atteints d’un cancer du poumon non à petites cellules (CPNPC) localement avancé ou métastatique, qui présentent des mutations par insertion au niveau de l’exon 20 du récepteur du facteur de croissance épidermique (EGFR).

Description de l'essai

Primary Outcome:

• Progression Free Survival (PFS) as Assessed by Blinded Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumours (RECIST) Version 1.1

Secondary Outcome:

• Confirmed Objective Response Rate (ORR) as Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
• Overall Survival (OS)
• Progression Free Survival (PFS) as Assessed by the Investigator
• Confirmed Objective Response Rate (ORR) as Assessed by the Investigator
• Duration of Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
• Time to Response, as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
• Disease Control Rate (DCR) as Assessed by the Blinded Independent Review Committee (IRC) and the Investigator
• Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
• Participant-reported Symptoms as Assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, Lung Cancer Module (QLQ-LC13)

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 NSCLC whose tumours 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) Platinum-based Chemotherapy Group (Arm B) 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. This multi-centre trial will be conducted in United States (US), Europe, and Asia. The overall time to participate in this study is until 3 years after the last participant is randomized. Participants will make multiple visits to the clinic and will be followed for survival, subsequent anticancer therapy, subsequent disease assessment outcome until disease progression on a subsequent anticancer therapy, and participant-reported health status (EuroQoL-5 Dimensions-5 Levels [EQ-5D-5L]) for 3 years after the last participant is randomized in the study and 30 days after the last dose of study drug for safety follow-up.

Voir cet essai sur ClinicalTrials.gov