Evaluating genetic changes in lung cancer patients after oxitinib treatment
Official title: A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers After Three Weeks of Osimertinib Targeted Therapy in Chinese Patients With Stage IIIB ,IIIC ,or IV Metastatic or Recurrent Non Squamous EGFR-positive Non-small Cell Lung Cancer
Run by Beijing Cancer Prevention & Treatment Society · NCT06422546 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 950 (estimated) |
| Sponsor | Beijing Cancer Prevention & Treatment Society Academic / other |
| Drugs / interventions | osimertinib, immunotherapy |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | January 13, 2022 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT06422546 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who have previously undergone treatment with EGFR-TKIs or immunotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success in characterizing genetic mutations in lung cancer, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female,age ≥18 years. 2. Newly diagnosed,histologically confirmed,and classified as stage IIIB,IIIC,IV or recurrent NSCLC which are not amenable to curative surgery or radiotherapy . 3. No prior systemic antitumor therapy, including EGFR -TKIs or immunotherapy . 4. Presence of an EGFR mutation confirmed by a local laboratory in blood or tissue samples . 5. Adequate blood samples available for molecular testing . 6. Provision of written informed consent . Exclusion Criteria: 1. Inability to provide plasma samples at baseline . 2. Baseline blood EGFR mutation status not confirmed by the central laboratory . 3. Refusal to receive subsequent treatment with osimertinib . 4. Any condition that ,in the investigator's judgment ,could interfere with study procedures or confound outcome assessment .
Where it's running
-
Cancer Hospital Chinese
Beijing, China Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases
This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.
-
Izalontamab Brengitecan with Osimertinib in EGFR-mutant NSCLC: first-line versus standard options
This study tests whether adding iza-bren to osimertinib can help people with newly diagnosed EGFR-mutant non-small cell lung cancer, compared with osimertinib alone or osimertinib plus platinum-based chemotherapy.
-
BL-B01D1 with Osimertinib before/around surgery for EGFR-mutant resectable NSCLC
A Phase II/III trial tests if adding BL-B01D1 to osimertinib around surgery helps people with resectable EGFR-mutant non-small cell lung cancer.
-
Barriers and facilitators to sticking with osimertinib after early-stage NSCLC
This study asks how adults with early-stage NSCLC in China continue or stop adjuvant osimertinib, by talking with patients and doctors to understand what helps or hinders persistence.
-
Ivonescimab with datopotamab deruxtecan or osimertinib for EGFR‑mutant non‑small cell lung cancer
This trial will test whether combining ivonescimab with datopotamab deruxtecan or with osimertinib is safe and helps people with metastatic EGFR‑mutant non‑small cell lung cancer who have already received third‑generation EGFR inhibitors and chemotherapy.
-
Boosting Osimertinib brain penetration with febuxostat in EGFR-mutated NSCLC
This study tests whether adding febuxostat to osimertinib can increase osimertinib levels in the brain for patients with EGFR-mutated NSCLC who do not have CNS metastases.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.