Phase II Study of AK112 with Chemotherapy for Advanced Non-Squamous Non-Small Cell Lung Cancer and Malignant Pleural Effusion

What this Trial Is About

Researchers are evaluating the combination of AK112, a PD-1VEGF bispecific drug, with chemotherapy in patients who have stage IV non-squamous non-small cell lung cancer NSCLC with malignant pleural effusion. This phase II study aims to assess the effectiveness and safety of this treatment approach in this specific lung cancer population with an ECOG performance status of 0 to 2. Participants receive AK112 along with chemotherapy drugs Pemetrexed and either Carboplatin or Cisplatin on the first day of every three-week cycle for four cycles. After these initial cycles, they continue treatment with AK112 plus Pemetrexed until their disease progresses. This treatment schedule is designed to evaluate the combinations impact on cancer with malignant pleural effusion over time. During the study, participants will be monitored for tumor response using RECIST 1.1 criteria and assessed for objective response rate of malignant pleural effusion over approximately two years. Additional measurements include progression-free survival, overall survival rates, duration of response, and disease control rates. Safety monitoring and organ function assessments are also conducted throughout. The total participation period may last up to two years, with ongoing evaluation of treatment effects and patient health.

A Phase II Study of AK112 (PD1/VEGF Bispecific) in Combination with Chemotherapy in Patients with NSCLC