Study of SG Combinations in Patients with Lung Cancer

• Research type

  Research Study

• Full title

  An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non−Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations

• IRAS ID

  1004738

• Contact name

  N/A N/A

• Contact email

  N/A

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2021-004280-27

• Clinicaltrials.gov Identifier

  NCT05186974

• Research summary

  This is a phase 2, open-label, multicentre study to evaluate the safety and efficacy of Sacituzumab Govitecan (SG) in combination with pembrolizumab or with pembrolizumab and a platinum agent in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) without actionable genomic alterations. Lung cancer is the main cause of cancer related death worldwide and approximately 80-85% of all lung cancers are NSCLC. The purpose of this study is to see if Sacituzumab Govitecan combinations can prolong survival in participants with NSCLC.
  Participants will receive the study medication until progressive disease, death, unacceptable toxicity or another treatment discontinuation is met.

  The participants will undergo procedures such as medical history, CT or MRI scans, or bone scans, blood and urine tests and a other clinical study assessments. The study doctor will also review previous/current medications.

  This study is sponsored by Gilead Sciences Inc.

• REC name

  West of Scotland REC 1

• REC reference

  22/WS/0044

• Date of REC Opinion

  16 May 2022

• REC opinion

  Further Information Favourable Opinion