NCT04646330

A Trial of AK104 Plus Anlotinib in NSCLC

A Phase Ib/II Trial of AK104 Plus Anlotinib in Patients With NSCLC

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a single arm, two cohorts, phase Ib/II study. All patients are stage IIIB/C or IV NSCLC, Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Cohort 1 includes treatment naïve patients with advanced NSCLC. Cohort 2 includes patients with metastatic or recurrent NSCLC after progression on treatment with PD-1/PD-L1. The primary end point are objective response rate per RECIST1.1 and safety. Secondary end points are progression-free survival and overall survival.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	AK104+anlotinib	Subjects receive AK104 10mg/kg intravenously (IV) every 2-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
DRUG	AK104+anlotinib	Subjects receive AK104 15mg/kg intravenously (IV) every 3-week cycle plus anlotinib on Day 1-14 of every 3-week cycle (Q3W) until progression.
DRUG	AK104+anlotinib	Subjects receive AK104 10mg/kg Q3W plus anlotinib 1-14days of every 3-week cycle until progression.

Timeline

• Start date: 2020-11-18
• Primary completion: 2023-10-26
• Completion: 2025-07-30
• First posted: 2020-11-27
• Last updated: 2025-08-19

Locations

1 site across 1 country: China