Clinical trial · Interventional
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
NCT07538804CI-TRIAL-00116766recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ANS02 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ANS02
- description
- ANS02 capsules, oral administration
- interventionNames
- Drug: ANS02
Primary outcomes (4)
- measure
- Incidence of Adverse Events (AEs)
- timeFrame
- From the time of first dose to 28 days post last dose of ANS02
- description
- Number of patients with adverse events by system organ class and preferred term
- measure
- Incidence of Serious Adverse Events (SAEs)
- timeFrame
- From time of first dose to 28 days post last dose of ANS02
- description
- Number of patients with serious adverse events by system organ class and preferred term
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.