MK-1084 with Pembrolizumab in 1L KRAS Mutant, Metastatic NSCLC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Metastatic NSCLC With PD-L1 TPS ≥50%

• IRAS ID

  1009675

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT06345729

• Research summary

  Researchers are testing ways to treat metastatic non-small cell-lung cancer (NSCLC) with tumours that have gene mutations called KRAS G12C. Metastatic means the cancer has spread to other parts of the body. Gene mutation is a change of DNA order.

  Standard treatment for NSCLC is immunotherapy, like pembrolizumab, that helps the immune system fight cancer. MK-1084, is a targeted therapy for the KRAS G12C mutation. Targeted therapy works to control how types of cancer cells grow and spread.

  The goal of this study is to learn if people who receive MK-1084 and pembrolizumab live longer and without the cancer getting worse compared to people who receive placebo and pembrolizumab. A placebo looks like the study medicine but has no study medicine in it. This helps researchers understand the effects of the study medicine.
  About 600 people, 18 years or older, will have an equal chance to receive MK-1084 and pembrolizumab or placebo and pembrolizumab.

  MK-1084 or placebo is taken every day as a tablet until the cancer gets worse or the person doesn’t tolerate it.
  Pembrolizumab is given once every 3 weeks as an intravenous (IV) infusion for up to 2 years unless the cancer gets worse or the person doesn’t tolerate it.

  Neither the people in the study nor the researchers will know which treatment a person is taking (double-blind). During the study, people will give blood and tumour tissue samples, have imaging tests, physical examinations and answer sets of questions about their health and ability to do daily tasks.

  A person may be in this study for about 4 and a half years.

  This study has an external group of experts who oversee the overall risk and benefit. If they decide that the study treatment is not safe or does not show benefit, the study can be stopped.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  24/SC/0391

• Date of REC Opinion

  29 Jan 2025

• REC opinion

  Further Information Favourable Opinion