STAR-121 - Ph III study ZIM and DOM+Chemo VS PEMBRO+Chemo in untreated metastatic NSCLC

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

• IRAS ID

  1006039

• Contact name

  Kelly Curtis

• Contact email

  kelly.curtis@gilead.com

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2022-000578-25

• Clinicaltrials.gov Identifier

  NCT05502237

• Research summary

  This is a randomised, open-label study to evaluate Zimberelimab (ZIM) and Domvanalimab (DOM) in combination with chemotherapy versus Pembrolizumab (PEMBRO) with chemotherapy in patients with untreated Metastatic Non–Small Cell Lung Cancer with no mutations in certain genes. Patients who received chemotherapy at least 12 months prior to the start of study treatment are eligible.

  ZIM and DOM are antibodies that could block the interaction between certain proteins on cancer cells and immune cells, boosting the immune response against cancer cells. The study’s main purpose is to determine whether ZIM alone, or with DOM, in combination with chemotherapy are safe and effective in this patient group. The study will also look at how ZIM and DOM with chemotherapy compare to PEMBRO (the standard drug used now) with chemotherapy. During the study, the quality of life and health status of patients will be evaluated.

  The study includes screening, treatment given once every three weeks, and follow-up. ZIM, DOM, or PEMBRO will be given until disease progression, intolerable toxicities, or for a maximum of 35 doses. The follow-up period will begin at the time of completion of the end of treatment visit. All participants will be followed for survival until death, lost to follow-up, withdrawal of consent, or study termination by Sponsor. The chemotherapy regimen will be selected by the investigator.

  Approximately 720 participants will be randomly allocated in a 4:4:1 ratio to Groups A, B, and C, respectively, as outlined below:
  - A: Approx. 320 participants will receive ZIM and DOM with chemotherapy
  - B: Approx. 320 participants will receive PEMBRO with chemotherapy
  - C: Approx. 80 participants will receive ZIM with chemotherapy

  This study is sponsored by Gilead Sciences, Inc..

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  23/SC/0091

• Date of REC Opinion

  6 Sep 2023

• REC opinion

  Further Information Favourable Opinion