An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination with Budigalimab in Advanced or Metastatic Non- Squamous NSCLC with No Prior Treatment for Advanced Disease, and No A
Objective: The study will assess the safety and efficacy of ABBV-400 in combination with budigalimab in subjects with locally advanced/metastatic non-squamous non-small cell lung cancer (NSCLC); who have no known actionable genomic alterations, and who have not been previously treated with frontline systemic therapy for advanced disease. Primary: To demonstrate the safety, tolerability, dose-limiting toxicity, maximum tolerated dose, and recommended phase 3 dose (RP3D) of ABBV-400 in combination with budigalimab. To evaluate the efficacy, as measured by objective response rate (ORR), of ABBV-400 in combination with budigalimab. Secondary: To evaluate clinical outcomes, such as progression-free survival (PFS), duration of response (DOR), overall survival (OS), and disease control rate (DCR), of ABBV-400 in combination with budigalimab. To characterize the pharmacokinetics (PK) and immunogenicity of ABBV-400 in combination with budigalimab. To evaluate pharmacodynamic and potential predictive biomarkers and their association with PK, safety, and efficacy.