Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This is a prospective, open, single-center, single-arm phase II clinical study with common EGFR-sensitive mutations (Ex19del and L858R) identified in the central laboratory.To evaluate the efficacy and safety of adjuvant Osimertinib therapy in completely resected stage I non-squamous non-small cell lung cancer (NSCLC) with high-risk factors (solid and/or micropapillary component ≥10%, and/or airway spread).

Eligibility criteria

Qualifiers

The subject will voluntarily sign the informed consent in person, and provide the informed consent before any specific study procedures;

Male and female, ≥18 years old;

Primary non-squamous NSCLC confirmed histologically by the central laboratory;

Brain imaging examinations should be performed before surgery or enrollment;

Disqualifiers

Exposure to other antitumor therapies before enrollment;

Patients who only received segmental resection and wedge resection;

History of other malignancies, other than non-melanoma skin cancer, carcinoma in situ or other solid tumors that have been effectively treated, and the treating physician has determined that there is no evidence of disease recurrence for 5 years after treatment;

Evidence of any severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any condition that the investigator considers to be detrimental to patient participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Omission requirement for screening chronic diseases;

Trial design

Treatments tested in this trial

  • Osimertinib

Treatment groups

65 Participants
are divided into 1 treatment group