CA052-1000 Ph2 Study of Imzokitug+Pumitamig+PDCT in Participants with Locally Adv or Metast NSCLC
Research type
Research Study
Full title
A Phase 2, Randomized, Open-label, Study Assessingthe Safety, Tolerability and Efficacy of Imzokitugin Combinationwith Pumitamigand Platinum-Doublet Chemotherapy (PDCT)versus Pumitamigand PDCT as First-line Treatment forParticipants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
1014202
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2026-525170-19
ISRCTN Number
N/A
Research summary
There remains a significant need for better treatments for people with advanced or metastatic non small cell lung cancer (NSCLC). People whose tumours have very low levels of PDL1 (below 1%) often do not respond as well to current first line immunotherapy treatments, or the treatment may stop working over time. Researchers are therefore studying new combinations of medicines that may help the immune system recognise and attack cancer more effectively.
CA0521000 is a randomised, open-label, multi-centre Phase 2 study. It will assess the safety and anti tumour activity of adding the investigational immunotherapy imzokitug (BMS 986340) to pumitamig plus platinum doublet chemotherapy (PDCT) as first line treatment for people with locally advanced or metastatic NSCLC. Imzokitug works by helping the body’s immune system do its job better by removing some barriers that stop it attacking cancer. Pumitamig works in two ways—it helps the immune system recognise cancer cells more easily and also slows down the cancer’s growth. Pumitamig is also currently being investigated in other clinical trials for NSCLC.
Adults with Stage IV (advanced) or recurrent NSCLC that cannot be removed with surgery will be able to take part. All participants must have tumours with PD L1 below 1% and must not have had any previous drug treatment for advanced disease. Participants will be randomly assigned (by chance) to one of four groups. Three groups will receive different doses of imzokitug together with pumitamig and PDCT. One group will receive pumitamig and PDCT without imzokitug.
All study medicines are given into a vein (intravenous infusion). Each treatment cycle lasts 21 days. Chemotherapy will be given for the first 4 cycles. Immunotherapy may continue for up to 2 years if the participant is benefiting and side effects are manageable. Participants may be followed for up to 4 years in total, including follow up after treatment ends.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
26/SC/0195
Date of REC Opinion
20 Jul 2026
REC opinion
Further Information Favourable Opinion