MK-1084 with MK-3475A in 1L KRAS G12C-mutant nonsquamous NSCLC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)

• IRAS ID

  1012288

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07190248

• Research summary

  Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that has a gene mutation called KRAS G12C and is either advanced or metastatic. Standard treatments for this type of NSCLC cancer may include immunotherapy, such as pembrolizumab, with or without chemotherapy.

  Researchers want to learn if the trial medicines MK-1084 and subcutaneous (SC) pembrolizumab can be used to treat NSCLC when given together. MK-1084 is a targeted therapy for the KRAS G12C mutation.

  About 675 participants, at least 18 years old, with advanced or metastatic NSCLC will be in this trial.

  Researchers will assign participants by equal chance to one of these groups:
  • Group 1: MK-1084 with SC pembrolizumab
  • Group 2: SC pembrolizumab with chemotherapy

  Participants will receive SC pembrolizumab, every 6 weeks given under the skin as a subcutaneous (SC) injection. Chemotherapy will be given as an IV infusion every 3 weeks. Participants will receive MK-1084, taken as a tablet by mouth once a day.

  Participants will receive SC pembrolizumab for about 2 years. Participants will receive treatment until the cancer gets worse or the treatment is not tolerated.

  Both the participants and the researchers will know which trial treatment a participant is getting. Participants may give blood, and tumour samples during the trial. They will have physical examinations, tests to check their heart (electrocardiograms or ECGs), and answer questions about how they are feeling. Participants may be in this trial for up to about 5 years.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  25/SC/0319

• Date of REC Opinion

  3 Dec 2025

• REC opinion

  Further Information Favourable Opinion