CA2390004 (KRYSTAL-4) Phase 3 study of Adagrasib in NSCLC
Research type
Research Study
Full title
A Randomized, Double-Blind, Phase 3 Trial of Adagrasib plus Pembrolizumab plus Chemotherapy vs. Placebo plus Pembrolizumab plus Chemotherapy in Participants with Previously Untreated, Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer with KRAS G12C Mutation (KRYSTAL-4)
IRAS ID
1011001
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company.
Clinicaltrials.gov Identifier
Research summary
Study CA2390004 (KRYSTAL-4) is a global study of a new cancer therapy called adagrasib (BMS-986503). The study will compare two treatments: (1) adagrasib together with pembrolizumab and chemotherapy (Arm A) vs (2) a placebo together with pembrolizumab and chemotherapy (Arm B) in participants with previously untreated non-small cell lung cancer (NSCLC) that has spread to another part of the body (metastatic). Pembrolizumab is an immunotherapy drug approved for the treatment of patients with metastatic lung cancer. Adagrasib is approved for the treatment of patients with metastatic NSCLC that have a KRAS G12C mutation.\n\nParticipants will be 18 years or older, have a specific type of NSCLC (non-squamous) that expresses a protein called programmed death receptor ligand-1 (PD-L1) which affects how well the body fights cancer cells, and a mutation in a gene called KRAS (KRAS G12C) which causes cancer cells to grow and divide out of control.\n\nAbout 630 participants will take part in this study world-wide, including participants in the UK.\n\nParticipants will be randomly divided into two treatment groups:\nArm A: Adagrasib + pembrolizumab + chemotherapy \nArm B: Placebo + pembrolizumab + chemotherapy \n\nThe aim of this study is to understand how well adagrasib works in preventing progression of the cancer in combination with pembrolizumab and chemotherapy (efficacy) and to understand its side effects (safety). \n\nThe study has four periods: screening, treatment, safety, and long-term follow-up. Participants will receive treatment until their cancer gets worse, they chose to leave the study, or the study doctor decides it is best for them to stop treatment. Participants will visit the study hospital to undergo tests and review their health with the study team and will be followed-up for up to 7 years from the start of treatment to monitor response to treatment and health.
REC name
Wales REC 2
REC reference
24/WA/0333
Date of REC Opinion
30 Jan 2025
REC opinion
Further Information Favourable Opinion