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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04544644
Study type Interventional
Source Chinese PLA General Hospital
Contact weiwei Shi
Phone +86 01066875308
Email shiweiwei301@sina.com
Status Not yet recruiting
Phase Phase 2
Start date September 2020
Completion date September 2023

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