TROPION-Lung07

• Research type

  Research Study

• Full title

  A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab, with or Without Platinum Chemotherapy, in Subjects with No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations(TROPION-Lung07)

• IRAS ID

  1006596

• Contact name

  Eric Richards

• Contact email

  TBEU-clinicaltrials@daiichi-sankyo.eu

• Sponsor organisation

  Daiichi Sankyo, Inc.

• Eudract number

  2022-003878-23

• Clinicaltrials.gov Identifier

  NCT05555732

• Research summary

  Lung cancer is the most common cancer with around 47,000 people diagnosed in the UK each year. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of lung cancers.
  The study drug Datopotamab Deruxtecan (Dato-DXd) is being developed by Daiichi Sankyo, Inc., to compare how effectively it works in combination with or without platinum-based chemotherapy, vs pembrolizumab plus pemetrexed and platinum-based chemotherapy in patients with advanced or metastatic non-squamous NSCLC who have had no prior therapy for advanced/metastatic disease. The primary measure of effectiveness of Dato-DXd is determined by how long a study participant survives without the disease getting worse.
  Approximately 975 adults will be assigned randomly to 1 of 3 study Arms in equal numbers, like drawing straws:
  • Arm A:participants will be treated with Dato-DXd and cisplatin or carboplatin added to pembrolizumab
  • Arm B:participants will be treated with Dato-DXd added to pembrolizumab (without platinum chemotherapy)
  • Arm C:pemetrexed and cisplatin or carboplatin will be added to pembrolizumab (without Dato-DXd)
  Study duration will depend on how each participant’s cancer responds to the study drug (Dato-DXd) as well as how long they are able to be safely treated without significant side effects. There is a maximum of 35 cycles (approx 2 years) for pembrolizumab and a maximum of 4 cycles for platinum chemotherapy. The choice of platinum chemotherapy will be decided by the study doctor. There is no maximum treatment duration for Dato-DXd and pemetrexed. After study treatment ends participants will be asked to attend a 30-day follow-up visit, and additional FU visits every 3 months.
  Current standard of care treatment for patients with advanced or metastatic non-squamous NSCLC is platinum-based chemotherapy with pembrolizumab and pemetrexed, but survival rates are not great. There is a need to design new combination therapies for NSCLC with fewer side effects to improve survival

• REC name

  Wales REC 3

• REC reference

  23/WA/0015

• Date of REC Opinion

  4 Sep 2023

• REC opinion

  Further Information Favourable Opinion