Phase 3 Open-label study of TAK-788 in NSCLC

• Research type

  Research Study

• Full title

  A Randomized Phase 3 Multicenter 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

• IRAS ID

  273315

• Contact name

  Sanjay Popat

• Contact email

  sanjay.popat@rmh.nhs.uk

• Sponsor organisation

  Millennium Pharmaceuticals, Inc. (wholly owned subsidiary of Takeda Pharmaceuticals)

• Eudract number

  2019-001845-42

• Clinicaltrials.gov Identifier

  NCT04129502

• Clinicaltrials.gov Identifier

  U1111-1232-6059, WHO universal trial number

• Duration of Study in the UK

  5 years, 2 months, 0 days

• Research summary

  Lung cancer is the leading cause of cancer-related deaths worldwide. Of the 2 main types of lung cancer (small cell lung cancer and non–small cell lung cancer [NSCLC]), NSCLC represents over 85%. Most patients with NSCLC present with either locally advanced or metastatic disease, with 70%- 80% of patients presenting with potentially inoperable, later-stage disease, thereby contributing to a 5-year overall survival rate of approximately 15% - 17%.

  NSCLC with EGFR exon 20 insertion mutations is a life-threatening disease involving rare mutations for which there is currently no approved or adequate therapy available, and constitutes a distinct, well-defined patient population with urgent unmet medical needs.

  TAK-788 is an irreversible TKI (tyrosine kinase inhibitor) that forms a covalent bond with cysteine 797 in EGFR, resulting in increased selectivity/potency and sustained inhibition of EGFR signaling. TAK-788 was designed to address the limitations of current EGFR TKIs. It has superior potency against EGFR exon 20 insertion mutations with reduced dose-limiting, class-related toxicities.

  This is an open-label randomized study to compare efficacy of TAK-788 as first-line treatment versus platinum-based chemotherapy in patients with NSCLC with EGFR exon 20 insertion mutations.

  Participants will be randomly assigned to one of two groups in a 1:1 ratio:
  • TAK-788 Group OR
  • Chemotherapy Group who will receive platinum-based chemotherapy of the investigator’s choice of either:
  - combination of pemetrexed and cisplatin OR
  - combination of pemetrexed and carboplatin

  Participants will continue to be treated with TAK-788 or chemotherapy until they experience progressive disease (PD), intolerable toxicity, or another discontinuation criterion. Maximum study duration will be 5 years.

  Study assessments will include blood tests, physical exam, ECG, questionnaires, imaging, tumour tissue biopsy.

  This study is sponsored by Millennium Pharmaceuticals, Inc. (MPI) (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited). Approximately 318 patients will be recruited globally with approximately 5 in the UK.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  20/LO/0070

• Date of REC Opinion

  3 Mar 2020

• REC opinion

  Further Information Favourable Opinion