NCT04544644

A Study of Combination Therapy in NSCLC

A Phase II Study of AK104 (Binding Kenetics to PD-1 and CTLA-4) in Combination With Anlotinib in Patients With Advanced NSCLC

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single arm, two cohorts, phase II study. All patients are stage IIIB-IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene. Cohort 1 includes patients with metastatic or recurrent NSCLC after progression on treatment with platinum-based chemotherapy and PD-1/PD-L1, given concurrently or sequentially. Cohort 2 includes treatment naïve patients with advanced NSCLC. All patients will recieve AK104 15mg/kg every 3 weeks(for up to 2 years) and anlotinib(12mg/d). The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	AK104+anlotinib	AK 104 is given by intravenous infusion and anlotinib is given by oral.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2020-09-10
• Last updated: 2020-09-10