drugset / Trial / NCT06635824

Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer (ABBIL1TY NSCLC-06)

NCT06635824

Phase 3 Active not recruiting 191 enrolled Genmab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized, open-label, international, Phase 3 trial to evaluate the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel (standard of care) in participants with locally advanced (unresectable stage IIIB/C) or programmed death ligand 1 (PD-L1)-positive metastatic non-small cell lung cancer (NSCLC) who have been treated with programmed cell death protein 1 (PD-1)/PD-L1 inhibitor and platinum-containing chemotherapy, administered either in combination or sequentially in the locally advanced (unresectable stage IIIB/C) or metastatic setting.

Timeline

Start
2024-11-25
Primary completion
2027-07-30
Completion
2028-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Acasunlimab Monoclonal antibody 100 mg Intravenous
Comparator Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous

Indications

No indication recorded.