Actively Recruiting
Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2023-01-17
65
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must voluntarily sign informed consent before any study procedures
- Male or female aged 18 years or older
- Histologically confirmed primary non-squamous NSCLC by central laboratory
- Brain imaging performed before surgery or enrollment
- Clinically confirmed stage I NSCLC by imaging using the eighth edition TNM lung cancer staging
- Tumor confirmed by central lab to have EGFR mutations Ex19del or L858R, alone or with other EGFR mutations including T790M
- Complete surgical resection of primary NSCLC with negative margins; lobectomy by open surgery or VATS allowed
- Pathology confirmed solid and/or micropapillary component ≥10%, or positive spread through air spaces (STAS)
- Osimertinib treatment started within 10 weeks after surgery
- WHO performance status score of 0 or 1
- Provide adequate surgical tissue samples (paraffin sections, wax blocks, or fresh frozen tissue)
- Females of childbearing potential must use effective contraception and have a negative pregnancy test before drug start or meet criteria for non-fertility
- Male participants must agree to use barrier contraception
You will not qualify if you...
- Prior exposure to other anti-tumor therapies before enrollment
- Patients who only had segmental or wedge resection
- History of other cancers except certain treated non-melanoma skin cancers or carcinoma in situ with no recurrence for 5 years
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, active bleeding, or active infections such as hepatitis B, hepatitis C, or HIV
- Significant heart conditions including prolonged QTc >470 ms, severe ECG abnormalities, heart failure, or factors increasing arrhythmia risk
- History or evidence of interstitial lung disease or radiation pneumonia requiring steroids
- Inadequate bone marrow reserve or organ function per laboratory criteria
- Known allergy to Osimertinib or similar drugs
- Uncontrolled nausea, vomiting, gastrointestinal illness, or conditions preventing drug absorption
- Evidence of corneal injury on eye exam
- Pregnant or nursing women
- Unlikely to comply with study procedures or restrictions as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
C
chen chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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