MK-3475A±MK-1084 in completely resected IIA-IIIB (N2) KRAS G12Cm NSCLC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) versus Adjuvant Placebo Plus MK-3475A in Participants with Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)

• IRAS ID

  1013329

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07431827

• Research summary

  Researchers are looking for new ways to treat early-stage, resectable non-small cell lung cancer (NSCLC) with tumours that have a KRAS G12C mutation (a DNA change).

  Standard treatment can include surgery, chemotherapy, and immunotherapy. Chemotherapy works by destroying cancer cells or stopping their growth. Immunotherapy, such as subcutaneous (SC) pembrolizumab (MK-3475A), helps the immune system fight cancer.

  The trial goal is to learn if people who receive MK-1084 and SC pembrolizumab after surgery live longer without the cancer returning compared to those receiving placebo and SC pembrolizumab. A placebo looks like trial medicine but has no medicine. MK-1084 controls how specific cancer cells grow and spread.

  Up to 400 people aged 18 years or older can take part if they:
  • Had or can have surgery to remove lung cancer
  • Do not have certain heart problems

  This trial has 2 parts:
  Part 1 – Neoadjuvant or Adjuvant Treatment
  People who have not yet received neoadjuvant (cancer treatment before surgery) or adjuvant therapy (cancer treatment after surgery) can join Part 1 and may receive:
  • Neoadjuvant Treatment: Before surgery, some participants will receive SC pembrolizumab every 6 weeks and chemotherapy every 3 weeks for about 3 months.
  • Adjuvant Treatment: After surgery, some participants will receive chemotherapy every 3 weeks for about 3 months.
  Part 2 – Investigational Adjuvant Treatment
  People who have had surgery, show no signs of cancer, and received certain neoadjuvant or adjuvant treatments can join Part 2. Participants will be randomly assigned to one of two groups:
  • Group 1: MK-1084 (once a day) up to 3 years and SC pembrolizumab (every 6 weeks) about 1 year
  • Group 2: Placebo (once a day) up to 3 years and SC pembrolizumab (every 6 weeks) about 1 year

  A participant may be in this trial for about 11 years.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  26/NE/0056

• Date of REC Opinion

  19 May 2026

• REC opinion

  Further Information Favourable Opinion