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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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084613
Enrollment
Unknown
Registered
2024-05-21
Start date
2022-01-27
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

oxitinib:None

Sponsors

Cancer Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Data of plasma ctDNA EGFR mutation status and mutation type at baseline and ctDNA EGFR clearance 3 weeks after treatment were obtained by SuperARMS-PCR testing.;

Secondary

MeasureTime frame
The correlation between EGFR-sensitive mutation clearance and PFS was monitored by SuperARMS-PCR testing.;

Countries

China

Contacts

Public ContactWang Jie

Cancer Hospital Chinese Academy of Medical Sciences

zlhuxi@163.com+86 139 1070 4699

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026