Non-Small Cell Lung CancerPhase 1/2NCT07538804
A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer
A Phase 1/2 study testing ANS02 in people with Non-Small Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd. at 5 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- ANS02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 10 Jul 2026to 30 Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
China4 sites, 4 recruiting
- Not yet recruiting
Study Site
Chengdu, Sichuan
- Not yet recruiting
Research Site
Guangzhou, Guangdong
- Recruiting
Research Site
Harbin, Heilongjiang
- Not yet recruiting
Research Site
Zhengzhou, Henan
United States1 site, 1 recruiting
- Recruiting
Research Site
Fairfax, Virginia, 22031
About this study
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
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.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- ANS02
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANS02Drug
4 dose levels would be explored during the study.
| Study group | Role | What they receive |
|---|---|---|
| ANS02 | Experimental | ANS02 capsules, oral administration Receives: Drug: ANS02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Number of patients with adverse events by system organ class and preferred term
Measured: From the time of first dose to 28 days post last dose of ANS02
Incidence of Serious Adverse Events (SAEs)
Number of patients with serious adverse events by system organ class and preferred term
Measured: From time of first dose to 28 days post last dose of ANS02
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Measured: From time of first dose of ANS02 to end of DLT period (approximately 28 days)
Incidence of baseline laboratory finding, ECG and vital signs changes
Measured by laboratory and vital sign variables over time including change from baseline
Measured: From time of first dose to 28 days post last dose of ANS02
Secondary outcomes (11)
Pharmacokinetics of ANS02: Plasma PK concentrations
Measurement of plasma concentrations of ANS02
Measured: From date of first dose of ANS02 up until 7 days post last dose
Pharmacokinetics of ANS02: Area under the concentration time curve (AUC)
Measurement of PK parameters: Area under the concentration time curve (AUC)
Measured: From date of first dose of ANS2 up until 7 days post last dose
Pharmacokinetics of ANS02: Maximum plasma concentration of the study drug (C-max)
Measurement of PK parameters: Maximum observed plasma concentration of the study drug (C-max)
Measured: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Time to maximum plasma concentration of the study drug (T-max)
Measurement of PK parameters: Time to maximum observed plasma concentration of the study drug (T-max)
Measured: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Clearance
Measurement of PK parameters: the volume of plasma from which the study drug is completely removed per unit time (Clearance)
Measured: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Half-life
Measurement of PK parameters: Terminal elimination half-life (t 1/2)
Measured: From date of first dose up until 7 days post last dose
Proportion of patients with radiological response (ORR)
Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1
Measured: From date of first dose of ANS02 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)
Duration of Response (DoR)
The time from date of first response until date of disease progression or last evaluable assessment (RECIST v1.1) in the absence of progression
Measured: From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR)
The percentage of patients with confirmed CR or PR or having SD maintained (RECIST v1.1)
Measured: From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Progression free Survival (PFS)
The time from first dose until RECIST 1.1 defined disease progression or death due to any cause
Measured: From date of first dose of ANS02 up until date of progression or death due to any cause (approximately 2 years)]
Overall Survival (OS)
The time from the date of the first dose of study treatment until death due to any cause
Measured: From date of first dose of ANS02 up until the date of death due to any cause (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start10 Jul 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Avistone Biotechnology Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avistone Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538804
- Sponsor's protocol ID
- ANS02-I/II-01
- Status last verified
- May 2026
- First submitted
- 13 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07538804
- Acronym / sponsor ID
- ANS02-I/II-01
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Avistone Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ANS02 | Experimental | Drug: ANS02ANS02 capsules, oral administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANS024 dose levels would be explored during the study. | Drug | ANS02 |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: From the time of first dose to 28 days post last dose of ANS02
Number of patients with adverse events by system organ class and preferred term
Incidence of Serious Adverse Events (SAEs)
Time frame: From time of first dose to 28 days post last dose of ANS02
Number of patients with serious adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: From time of first dose of ANS02 to end of DLT period (approximately 28 days)
Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of baseline laboratory finding, ECG and vital signs changes
Time frame: From time of first dose to 28 days post last dose of ANS02
Measured by laboratory and vital sign variables over time including change from baseline
11 secondary outcomes
Pharmacokinetics of ANS02: Plasma PK concentrations
Time frame: From date of first dose of ANS02 up until 7 days post last dose
Pharmacokinetics of ANS02: Area under the concentration time curve (AUC)
Time frame: From date of first dose of ANS2 up until 7 days post last dose
Pharmacokinetics of ANS02: Maximum plasma concentration of the study drug (C-max)
Time frame: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Time to maximum plasma concentration of the study drug (T-max)
Time frame: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Clearance
Time frame: From date of first dose up until 7 days post last dose
Pharmacokinetics of ANS02: Half-life
Time frame: From date of first dose up until 7 days post last dose
Proportion of patients with radiological response (ORR)
Time frame: From date of first dose of ANS02 until progression, or the last evaluable assessment in the absence of progression （approximately 2 years)
Duration of Response (DoR)
Time frame: From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Disease Control Rate (DCR)
Time frame: From date of first dose of ANS02 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)
Progression free Survival (PFS)
Time frame: From date of first dose of ANS02 up until date of progression or death due to any cause (approximately 2 years)]
Overall Survival (OS)
Time frame: From date of first dose of ANS02 up until the date of death due to any cause (approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ANS02 in people with Non-Small Cell Lung Cancer, run by Avistone Biotechnology Co., Ltd. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Avistone Clinical Study Information Center (8610 84148921, information.center@avistonebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: From the time of first dose to 28 days post last dose of ANS02). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.