294 Participants NeededMy employer runs this trial

ANS02 for Non-Small Cell Lung Cancer

Recruiting at 4 trial locations
AC
Overseen ByAvistone Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Avistone Biotechnology Co., Ltd.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ANS02 for individuals with advanced non-small cell lung cancer (NSCLC). The main goal is to assess the safety and effectiveness of ANS02 on its own and its impact on tumors. Individuals diagnosed with NSCLC and a specific genetic change in their cancer (EGFR alteration) might be suitable candidates. The trial will evaluate whether ANS02 can halt cancer growth and identify any side effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ANS02 is likely to be safe for humans?

Research on ANS02, a treatment being tested for advanced non-small cell lung cancer (NSCLC), remains in the early stages. Consequently, information about its safety in humans is limited. This trial marks the first time ANS02 is tested in people. The trial's main goal is to assess the treatment's safety and patient tolerance.

While specific safety data from other studies on ANS02 is unavailable, researchers closely monitor patient reactions. Early trials aim to identify side effects and determine safe dosage levels. So far, no specific side effects from ANS02 have been reported, but early trials can still pose some risks.

Prospective participants should discuss potential side effects and study expectations in detail with the study team.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for non-small cell lung cancer, which often include chemotherapy and targeted therapies, ANS02 offers a fresh approach by potentially targeting cancer cells with a unique mechanism of action. Researchers are excited about ANS02 because it may work differently, focusing on pathways not typically addressed by current options. This innovative angle could lead to more effective treatments with fewer side effects, offering hope for improved patient outcomes.

What evidence suggests that ANS02 might be an effective treatment for NSCLC?

Research shows that ANS02 could help treat non-small cell lung cancer (NSCLC), particularly in patients with specific genetic changes like EGFR mutations. Although the exact results of ANS02 are still under investigation, other treatments with similar mechanisms have shown significant benefits. For example, Osimertinib, which also targets EGFR mutations, has successfully extended the lives of patients with advanced NSCLC. ANS02 blocks signals that promote cancer cell growth, potentially slowing or halting cancer progression. Early indications suggest that ANS02 could become a new option for patients with limited treatment choices.12467

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced non-small cell lung cancer that has a specific EGFR gene mutation. Participants must be in good physical condition, have measurable tumors, and healthy major organs. Life expectancy should be at least 12 weeks.

Inclusion Criteria

My life expectancy is at least 12 weeks.
I am fully active or can do light work despite my illness.
* Measurable disease per RECIST v1.1
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ANS02 as monotherapy to evaluate safety, tolerability, and preliminary efficacy

Approximately 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • ANS02

Trial Overview

The study is testing a new drug called ANS02 given alone to see if it is safe and effective for people with EGFR-mutated non-small cell lung cancer. This early-phase trial takes place at multiple centers and all participants receive the same treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ANS02Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Avistone Biotechnology Co., Ltd.

Lead Sponsor

Trials
10
Recruited
1,400+

Citations

A Study to Investigate ANS02 in Participants With EGFR ...

A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer. ClinicalTrials.gov ID NCT07538804. Sponsor ...

ANS02 for Non-Small Cell Lung Cancer · Info for Participants

... ANS02 will have tolerable side effects & efficacy for patients with Non-Small Cell Lung Cancer and Non-Small Cell Lung Cancer. Learn more about the study.

Ten-year follow-up outcomes of resected stage II non-small ...

The overall survival rate at 5 and 10 years was 55.0%and 40.7%, respectively, while the recurrence-free survival rate at 5 and 10 years were 53.9% and 49.0%, ...

2021 Midyear Review: Non–Small-Cell Lung Cancer

After 2 years, combination use of nivolumab and ipilimumab together with chemotherapy demonstrated durable survival and other efficacy benefits relative to ...

Interpreting Overall Survival and CNS Outcomes in EGFR ...

In this segment, Dr. Singhi discusses how overall survival data from recent phase 3 trials in EGFR mutated metastatic non-small cell lung ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40210967/

Sacituzumab tirumotecan in advanced non-small-cell lung ...

Overall, sac-TMT showed encouraging single-agent activity and manageable tolerability in previously treated, advanced NSCLC with EGFR mutations. Randomized ...

LUNG-02 clinical trial NCT06758401 | Pfizer

The Be6A LUNG-02 Clinical Trial is evaluating the safety and effectiveness of a study medicine (sigvotatug vedotin) used with a standard therapy (pembrolizumab)