Clinical trial · Observational
A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in EGFRm NSCLC
A Prospective, Multicenter, Non-interventional, Real-world Study to Characterize Changes in Molecular Markers After Three Weeks of Targeted Therapy With Oxitinib in Chinese Patients With Stage IV Metastatic or Recurrent Non-squamous EGFR-positive NSCLC
NCT06422546CI-TRIAL-00077353pre-FLAMEunknownClinicalTrials.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)
To evaluate the characteristics of genetic variationmutations at baseline and 3 weeks after oxitinib treatment in EGFRm NSCLC
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 (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- changes in EGFR gene mutations
- timeFrame
- baseline and 3 weeks after oxitinib treatment
- description
- To characterize the changes in EGFR gene mutations at baseline and 3 weeks after oxitinib treatment
Secondary outcomes (1)
- measure
- Characteristics of EGFR gene mutation and efficacy of oxitinib treatment
- timeFrame
- baseline and 3 weeks after oxitinib treatment
- description
- Characteristics of EGFR gene mutation and efficacy of oxitinib treatment at baseline and after 3 weeks of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years old male or female 2. Stage IV metastatic or recurrent non-squamous NSCLC that is newly diagnosed, histologically proven and not suitable for radical surgery or radiotherapy (AJCC V8); 3. Without prior systemic antitumor therapy including EGFR-TKI or immunotherapy; 4. EGFR positive in blood or tissue tested in local laboratory; 5. Sufficient blood samples can be provided for molecular detection; 6. Signed informed consent forms are available. Exclusion Criteria: 1. Patients were unable to collect plasma samples at baseline; 2. The EGFR mutant status of the patient's blood specimen at baseline has not been verified by the central laboratory; 3. The patient refused subsequent treatment with oxitinib; 4）The investigator determines that may affect the conduct of the clinical study and the judgement of the study results.
References
Publications (0)
Data not yet available
No reference posted for this study.