NCT07538804RecruitingPhase 1/2
A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 294 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 10 Jul 2026
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07538804
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 294
- From 10 Jul 2026 to the primary completion date, 30 Jun 2029
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active infection including tuberculosis and HBV, HCV or HIV
- Participants with serious cardiovascular or cerebrovascular diseases
Other
- Known active or untreated CNS metastases
- Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Study Site Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Research Site Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.