Trial results for the Phase 1/2a study (NCT04032847) investigating pembrolizumab in combination with ATL001 for patients with advanced unresectable or metastatic non-small cell lung cancer (NSCLC) were posted on ClinicalTrials.gov on 2025-03-10. The study, which enrolled 27 participants, was officially terminated.
Background
The study investigated ATL001, described as autologous clonal neoantigen reactive T cells (cNeT), administered intravenously in adults with advanced non-small cell lung cancer (NSCLC). Pembrolizumab (Keytruda) was also an intervention in the study. This was a first-in-human, open-label, multi-centre study designed to characterize the safety and clinical activity of ATL001.
Trial design
The study (NCT04032847) was an open-label, multi-centre, Phase 1/2a trial. It enrolled a total of 27 participants diagnosed with advanced non-small cell lung cancer (NSCLC). The interventions included ATL001 and pembrolizumab. The trial's overall status is listed as TERMINATED.
Key results
The trial's primary outcome was the assessment of Treatment Emergent Adverse Events (TEAEs) to evaluate safety and tolerability. The following participant counts were reported for TEAEs:
- For Cohort A, participant counts for TEAEs were reported as 21 participants, 19 participants, 16 participants, 16 participants, 16 participants, and 6 participants across various assessments.
- For Cohort C, participant counts for TEAEs were reported as 5 participants, 5 participants, 4 participants, 4 participants, 5 participants, and 0 participants across various assessments.
What this means
The termination of this Phase 1/2a study evaluating pembrolizumab with ATL001 in advanced NSCLC indicates that the trial did not proceed as originally planned. While specific reasons for termination are not detailed in the provided results, the available data focuses on the assessment of Treatment Emergent Adverse Events (TEAEs) in the enrolled participants. The counts of participants experiencing TEAEs were recorded for both Cohort A and Cohort C. Without further efficacy data or a stated reason for termination, the clinical implications of this combination therapy remain undefined based on these posted results.
Source
The information for this article was sourced from ClinicalTrials.gov, a public database of clinical studies. The trial results for study NCT04032847, titled "ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC," were posted on 2025-03-10 on clinicaltrials.gov.