Evaluating genetic changes in lung cancer patients after oxitinib treatment
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
This study is testing how genetic changes in lung cancer patients with specific mutations respond to three weeks of treatment with oxitinib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 950 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Cancer Prevention & Treatment Society Academic / other |
| Drugs / interventions | oxitinib, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06422546 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the characteristics of genetic mutations in patients with EGFRm non-small cell lung cancer (NSCLC) before and after three weeks of treatment with oxitinib. It is a multicenter, non-interventional, real-world study that focuses on understanding the efficacy of oxitinib and the mechanisms of treatment resistance. Blood samples will be collected to assess molecular markers at baseline and after treatment, providing insights into the genetic variations associated with the therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage IV metastatic or recurrent non-squamous NSCLC who have not received prior systemic antitumor therapy.
Not a fit: Patients who have previously undergone treatment with EGFR-TKIs or immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment responses in lung cancer, potentially leading to more effective therapies.
How similar studies have performed: Other studies have shown success in characterizing genetic mutations in lung cancer, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Cancer Prevention society — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.