ARTEMIDE-Lung03

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination with Platinum-based Chemotherapy for the First-line Treatment of Patients with Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)

• IRAS ID

  1010707

• Contact name

  Yehan Wijesinghe

• Clinicaltrials.gov Identifier

  NCT06627647

• Research summary

  This is an AstraZeneca sponsored phase III, double-blind randomized study investigating the effectiveness and safety of rilvegostomig plus chemotherapy to that of pembrolizumab plus chemotherapy in metastatic non-squamous non-small cell lung cancer expressing PD-L1.
  Rilvegostomig may help your immune system to find and attack cancer cells blocking signalling from two molecules called PD-1 and TIGIT on cells of your immune system. Cancer cells use PD-1 and TIGIT to avoid being attacked by the immune system. This trial hypothesizes that the Rilvegostomig plus chemotherapy will improve treatment efficacy over standard therapy. The participants will be randomized in a 1:1 ratio on the two arms. Pembrolizumab or rilvegostomig plus chemotherapy (cisplatin plus pemetrexed or carboplatin plus pemetrexed) will be administered for 4 cycles followed by maintenance with pembrolizumab, rilvegostomig and other chemotherapy (pemetrexed) until the discontinuation criteria are met. The chemotherapy a participant receives will be dependent on the decision of the patient’s doctor. In order to assess their eligibility to the trial, potential participants will undergo tests including blood, radiological exam (CT scan or MRI where applicable), cardiac function tests and physical exam. Some of these tests will be repeated to ensure treatment is tolerated and can be continued and to assess tumour response. This study will be conducted in approximately 350 sites, across 25-30 countries to dose 878 participants. Overall, the study duration will be approximately 66 months (event-driven).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  24/NW/0290

• Date of REC Opinion

  2 Dec 2024

• REC opinion

  Further Information Favourable Opinion