A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer

Recruiting now · Phase 1/Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

This is a first-in-human (FIH) Phase I/II, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS02 as monotherapy.

Key facts

Study ID

NCT07538804

Run by

Avistone Biotechnology Co., Ltd.

People needed

294

Starts

2026-07-10

Expected to finish

2029-10-30

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• Life expectancy ≥ 12 weeks
• Measurable disease per RECIST v1.1
• Adequate organ and marrow function as defined in the protocol
• With documentation of EGFR alteration

You may not qualify if…

• Active infection including tuberculosis and HBV, HCV or HIV
• Known active or untreated CNS metastases
• Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
• Participants with serious cardiovascular or cerebrovascular diseases

Where it is running

• Research Site — Fairfax, Virginia, United States (enrolling)
• Research Site — Harbin, Heilongjiang, China (enrolling)
• Research Site — Guangzhou, Guangdong, China
• Research Site — Zhengzhou, Henan, China
• Study Site — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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