CA240-0009: BMS-986504 in Pre-treated Advanced or Metastatic NSCLC with Homozygous MTAP Deletion
Research type
Research Study
Full title
A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) with Homozygous MTAP Deletion After Progression on Prior Therapies
IRAS ID
1011903
Contact name
Head of Global Submission Management - Clinical Trial
Contact email
Sponsor organisation
Bristol Myers Squibb Services Unlimited Company
Clinicaltrials.gov Identifier
Research summary
This study is evaluating the safety and effectiveness of a new drug, BMS-986504, for individuals with advanced or metastatic non-small cell lung cancer (NSCLC) who have a specific genetic mutation in the tumour called homozygous MTAP deletion. The study aims to determine whether BMS-986504 can benefit patients who have not responded well to previous treatments by assessing how the drug works, its effects on the body, and its overall safety.
Homozygous MTAP deletion occurs in the cancer in approximately 13% of patients with NSCLC and is associated with shorter survival and acquired resistance to drugs that use the immune system to target cancer.
This study will include adults aged 18 years or older and who have been diagnosed with advanced or metastatic NSCLC, specifically with a genetic mutation in the tumour called homozygous MTAP deletion. Participants will be randomly divided into two treatment groups, each allocated to a different dose of BMS-986504 to determine which may be safer and/or effective.
About 130 participants will take part in this study worldwide, including participants in the UK.
The study will take place at multiple locations. Participants will receive different doses of BMS-986504 and complete up to 3 study periods in Part 1: a screening period (up to 28 days), a treatment period (21-day cycles), as long as they are benefiting from treatment and do not have unacceptable side effects, and a follow-up period, which includes a safety visit 28 days after the last dose and survival follow-ups every 3 months for up to 3 years.
Participants will continue to receive BMS-986504 at the recommended dose in Part 2 without dosing interruptions until intolerable toxicity, death, or withdrawal of consent, whichever occurs first.REC name
London - Surrey Borders Research Ethics Committee
REC reference
25/LO/0295
Date of REC Opinion
26 Jun 2025
REC opinion
Further Information Favourable Opinion