REZILIENT3

• Research type

  Research Study

• Full title

  Randomized, Controlled, Open-label, Phase 3, Global MultiCenter Trial to Assess the Efficacy and Safety of Zipalertinib Plus Chemotherapy versus Chemotherapy alone, in Patients with Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

• IRAS ID

  1008054

• Contact name

  Jennifer Hodge

• Contact email

  JHodge@taihooncology.com

• Sponsor organisation

  Taiho Oncology, Inc

• Research summary

  The purpose of this clinical research study is to see how a new medication called zipalertinib works in combination with the kind of chemotherapy that is typically used to treat this kind of lung cancer. We would like to find out if adding zipalertinib to chemotherapy helps slow the spread of this type of lung cancer, and what side effects participants may experience.

  This clinical study will evaluate zipalertinib in combination with standard chemotherapy, which is a combination of pemetrexed (also called Alimta) and a choice between two similar kinds of platinum chemotherapy (either cisplatin or carboplatin) depending on the study doctor’s recommendation. Approximately half of the participants in this study will be randomly selected to receive this standard chemotherapy combination, while the other half will be randomly selected to receive the combination of zipalertinib plus standard chemotherapy.

  Approximately 200 sites will enrol around 300 participants in this study. The study consists of a Screening period, a Treatment period, a Safety Follow-up visit and a follow-up period. Participants will be required to visit the site approximately weekly for the first cycle of treatment, and then every 3 weeks. Assessments such as physical examinations, vital signs, blood and urine collect, eye examination, electrocardiogram, imaging scans and questionnaires will be performed.
  
  Participants will be asked to avoid natural sunlight or artificial light (sunbeds), wear protective clothing, lip-balm and sunscreen when outside, during their treatment period as the study medication may cause their skin to be more sensitive to UV light.

  Participants may receive the study treatment as long as the study is ongoing, providing that their cancer does not get worse, they do not have medically unacceptable side effects, and their study doctor determines their condition to be appropriate for the study.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  23/NE/0162

• Date of REC Opinion

  25 Sep 2023

• REC opinion

  Further Information Favourable Opinion