Changeflow GovPing Healthcare & Life Sciences ANS02 Phase 1 Study for EGFR Mutation-Positive ...
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ANS02 Phase 1 Study for EGFR Mutation-Positive NSCLC

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Summary

NIH registered a first-in-human Phase 1 clinical trial (NCT07538804) evaluating ANS02 monotherapy in patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC). The multi-center, open-label study will assess safety, tolerability, preliminary efficacy, pharmacokinetics, and anti-tumor activity. This registration documents the trial on ClinicalTrials.gov, supporting transparency requirements for federally funded clinical research.

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What changed

NIH registered a new first-in-human Phase 1/II clinical trial (NCT07538804) for ANS02, an investigational drug for EGFR mutation-positive non-small cell lung cancer. The study is multi-center, open-label, and will evaluate safety, tolerability, preliminary efficacy, pharmacokinetics, and anti-tumor activity as monotherapy. The trial is listed as Phase 1 with a status date of April 20, 2026.

For pharmaceutical companies and clinical research organizations, this registration demonstrates the continued use of ClinicalTrials.gov as the primary public registry for U.S. clinical trials, supporting transparency obligations under FDA regulations. Sponsors conducting similar oncology trials should ensure their studies are properly registered and updated in accordance with applicable disclosure requirements.

Archived snapshot

Apr 21, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Phase 1 NCT07538804 Kind: PHASE1 Apr 20, 2026

Abstract

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

Interventions: ANS02

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Last updated

Classification

Agency
NIH
Published
April 20th, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07538804

Who this affects

Applies to
Pharmaceutical companies Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Clinical trial registration Drug development Oncology research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Public Health Healthcare

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