Trial results for the PHASE1/PHASE2 study NCT05469178, investigating pembrolizumab in combination with bemcentinib and chemo-immunotherapy for advanced non-small cell lung cancer, were posted on ClinicalTrials.gov on 2025-10-29. The study, which enrolled 26 participants, was terminated, and reported 0 participants with an objective response rate at both 6 and 12 months in the Phase 2a expansion cohort.
Background
The study, titled "A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene," aimed to evaluate a combination therapy for locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC) patients with a mutation in the STK11 gene.
Trial design
The PHASE1/PHASE2 study (NCT05469178) was a clinical trial that enrolled 26 participants with Carcinoma, Non-Small-Cell Lung. The trial investigated the combination of bemcentinib with pembrolizumab, pemetrexed, and carboplatin as first-line treatment in participants with locally advanced or metastatic non-squamous NSCLC with serine/threonine kinase 11 (STK11) gene mutations. The primary purposes of the study were to determine the safety and tolerability to identify the recommended phase 2 dose (RP2D) and to determine the anti-tumor activity of the combination in this specific patient population. The study was ultimately terminated.
Key results
For the Phase 1b portion of the study, which aimed to assess dose-limiting toxicities (DLTs):
- In the "Phase 1b Cohort 1: Bemcentinib 75 mg" group, the number of participants with DLT was 0.
- In the "Phase 1b Cohort 2: Bemcentinib 100 mg" group, the number of participants with DLT was 0.
- In the "Phase 1b Cohort 3: Bemcentinib 150 mg" group, the number of participants with DLT was 0.
For the Phase 2a portion, which assessed anti-tumor activity:
- For the outcome "Objective Response Rate (ORR) at 6 Months" in the "Phase 2a Expansion Cohort: Bemcentinib 100 mg," the number of participants with an objective response was 0.
- For the outcome "Objective Response Rate (ORR) at 12 Months" in the "Phase 2a Expansion Cohort: Bemcentinib 100 mg," the number of participants with an objective response was 0.
What this means
The termination of the PHASE1/PHASE2 study NCT05469178 and the reported 0 objective responses at 6 and 12 months in the Phase 2a expansion cohort suggest that the combination of bemcentinib with pembrolizumab and chemo-immunotherapy did not demonstrate sufficient anti-tumor activity in this population of advanced non-small cell lung cancer patients to continue the trial. While no dose-limiting toxicities were observed in the Phase 1b cohorts, the lack of efficacy signals led to the study's termination.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05469178, titled "A Clinical Study of Bemcentinib With Standard of Care Chemoimmunotherapy in Untreated Advanced/Metastatic Non-small Cell Lung Cancer Patients With a Mutation in the STK11 Gene," were posted on 2025-10-29 on clinicaltrials.gov.