Bemcentinib + Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy (CIT) to identify the recommended phase 2 dose (RP2D) when administered as first line (1L) treatment in participants with locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received prior systemic treatment for their advanced/metastatic NSCLC.
What data supports the effectiveness of the drug combination Bemcentinib, Pembrolizumab, and Chemotherapy for Non-Small Cell Lung Cancer?
Research shows that combining pembrolizumab with chemotherapy, like carboplatin and pemetrexed, is effective in treating advanced non-small cell lung cancer, leading to longer survival times. This combination is now a standard first-line treatment, showing promising results in real-world studies.12345
Is the combination of Bemcentinib, Pembrolizumab, and Chemotherapy safe for humans?
The combination of pembrolizumab with chemotherapy drugs like pemetrexed and carboplatin has been studied for safety in non-small cell lung cancer, showing some side effects like pneumonitis (lung inflammation) in a small percentage of patients. Pemetrexed and carboplatin are generally well-tolerated, with less severe side effects compared to some other treatments.16789
What makes the Bemcentinib + Pembrolizumab + Chemotherapy treatment unique for non-small cell lung cancer?
This treatment is unique because it combines Bemcentinib, a novel drug, with Pembrolizumab and chemotherapy, which are already known to improve survival in non-small cell lung cancer. Bemcentinib may offer additional benefits by targeting specific cancer pathways, potentially enhancing the effectiveness of the existing combination.14101112
Eligibility Criteria
Adults with untreated advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that can't be cured by surgery or radiation, specifically those with STK11 mutation and no EGFR, ALK, ROS1, RET rearrangements, NRTK gene fusions, BRAF V600E or METex14 Skipping Mutations. Participants should not have had previous chemotherapy for their lung cancer.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bemcentinib with chemo-immunotherapy (CIT) as first line treatment for advanced/metastatic non-squamous NSCLC
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bemcentinib
- Carboplatin
- Pembrolizumab
- Pemetrexed
Find a Clinic Near You
Who Is Running the Clinical Trial?
BerGenBio ASA
Lead Sponsor