M24-536 NSCLC Telisotuzumab Adizutecan (ABBV-400) & PD-1 Immune Checkpoint Inhibitor Phase 1b/2
Research type
Research Study
Full title
An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC with No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations (AndroMETa-Lung-536)
IRAS ID
1011242
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Eudract number
2024-514465-18
Clinicaltrials.gov Identifier
Research summary
Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when
Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.
This study will be divided into two stages, and the UK is only participating in Stage 2. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be
studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 6 adult participants with NSCLC will be enrolled in the study in 2 sites in UK.
In the dose optimization stage (Part 2) participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of
approximately 33 months.REC name
Wales REC 3
REC reference
25/WA/0297
Date of REC Opinion
30 Oct 2025
REC opinion
Further Information Favourable Opinion