A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab versus Placebo, in Combination with Pembrolizumab, Pemetrexed, and Carboplatin, in First-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-01)

Metastatic non-squamous non-small cell lung cancer

Objective response rate (ORR), defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the Investigator at any time during the core trial period

Incidence, type, and severity of adverse events (AEs), treatment-emergent (TEAEs) and treatment-related AEs and serious AEs (SAEs), Complete response (CR) rate, Partial response (PR) rate, Objective response rate (ORR), Time to response (TTR), Duration of response (DOR), Progression-free survival (PFS), Overall survival (OS), Participant weight course over time, Maximum concentration (Cmax), Minimum concentration (Cmin), Participants’ subjective well-being as assessed via the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ), Participants' quality of life as assessed via the 5-day Functional Living Index-Emesis (5-day FLIE), focusing on the impact of chemotherapy-induced nausea and vomiting on daily activities and overall well-being

No related papers found yet.

Bulgaria, Germany, Italy, Poland, Romania, Spain