ANS02 for Advanced Lung Cancer With an EGFR Mutation
Tests the drug ANS02 in adults with EGFR-mutated non-small cell lung cancer.
Key facts
- Who runs it
- Avistone Biotechnology Co., Ltd.
- Where
- Chengdu, Guangzhou, Harbin, and Zhengzhou, ChinaSee the 4 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 294 people, planned
- Started
- 10 Jul 2026
- Expected to end
- 30 Oct 2029
- Type of study
- Interventional
- Treatments tested
- ANS02
- Record updated
- 6 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small cell lung cancer who have an EGFR change. It tests the new drug ANS02 on its own.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Advanced or metastatic non-small cell lung cancer with disease that can be measured on scans (RECIST v1.1).
- Biomarker or test result
- An EGFR alteration that is documented.
Main reasons for not taking part
- Active infection, including tuberculosis, HBV, HCV or HIV
- Known active or untreated brain or spinal metastases
- Carcinomatous meningitis, meningeal metastases or spinal cord compression
- Serious heart or brain blood vessel disease
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Active infection including tuberculosis and HBV, HCV or HIV
- Participants with serious cardiovascular or cerebrovascular diseases
- Known active or untreated CNS metastases
- Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
Where in China
Also in 1 other country, 1 site
- Chengdu, SichuanHospital not named in the registryNot yet recruiting
- GuangzhouHospital not named in the registryNot yet recruiting
- HarbinHospital not named in the registryTaking people
- ZhengzhouHospital not named in the registryNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- ANS02Treatment being tested
ANS02 capsules, oral administration
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS02 in Participants With EGFR Mutation-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Plain-language title
- ANS02 for Advanced Lung Cancer With an EGFR MutationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 6 July 2026