LEAP-006

• Research type

  Research Study

• Full title

  A Phase 3 Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Pemetrexed + Platinum Chemotherapy + Pembrolizumab (MK-3475) with or without Lenvatinib (E7080/MK-7902) as First-line Intervention in Participants with Metastatic Nonsquamous Non-small Cell Lung Cancer (LEAP-006)

• IRAS ID

  257429

• Contact name

  Samreen Ahmed

• Contact email

  Samreen.Ahmed@uhl-tr.nhs.uk

• Sponsor organisation

  Merck, Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR

• Eudract number

  2018-003824-35

• Duration of Study in the UK

  4 years, 8 months, 20 days

• Research summary

  The global incidence of lung cancer was 1.8 million in 2012, leading to 1.6 million deaths. Non-small cell lung cancer (NSCLC) represents 80%-85% of all lung cancers, with 70% having advanced disease. Previously the standard of care for advanced NSCLC was platinum-based doublet chemotherapy, however the development of immunotherapeutic agents such as Pembrolizumab has led to new treatments for NSCLC.

  Pembrolizumab has been developed to block PD1/PDL1 interaction. Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells die thus stopping them from attacking the cancer. When used in combination with chemotherapy, the average survival rate for advanced NSCLC increases from 1 year to >30 months. Despite this improvement many patients will die of their disease, therefore new treatments are needed.

  Lenvatinib works by blocking proteins called VEGFs which cancer cells can use to help themselves grow. Studies have shown that lenvatinib can also help increase the immune attack on cancers. Early studies show that the combination of lenvatinib and pembrolizumab can help increase the immune response against cancers cells and may provide a new treatment option for patients.

  This phase III study will last approximately 5 years and will recruit approximately 714 participants aged ≥18 years with advanced NSCLC. The study will evaluate the effectiveness and safety of pembrolizumab and chemotherapy in combination with lenvatinib vs placebo. Participants will be assigned randomly to one of two groups of the study.

  The study is sponsored by Merck Sharp & Dohme Limited (MSD), and co-funded by MSD and Eisai. It will take place at 10 study centres in UK.
  Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fmsd.trialsummaries.com%252FStudy%252FStudyDetails%253Fid%253D26810%2526tenant%253DMT_MSD_9011%2FNBTI%2F89C-AQ%2FAQ%2F094e1a5c-37af-478a-a7ed-ada1370613b9%2F1%2F9LK3iPN-Ys&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7C653fb9733a1a4e02a7df08ddebc15cf7%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638925937900906544%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=JlT8sRlM0ETX9b2YGR5Y44UiR5iKCz1K2gGCIF4DX18%3D&reserved=0
  

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  19/EM/0057

• Date of REC Opinion

  2 May 2019

• REC opinion

  Further Information Favourable Opinion