Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer
NCT03460275 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2018-03-09
Summary
Based on the existing research results, Osimertinibi is effective not only for patients with sensitizing EGFR mutations, but also for other less common EGFR mutations. However, no studies have been done so far regarding the difference in efficacy of various EGFR mutation subtypes. Meanwhile, the presenting studies data of the safety and efficacy of Osimertinib as first-line therapy for NSCLC is very limited. Therefore, this study aims at assessing the safety and efficacy of Osimertinib as First-line therapy for patients with EGFR mutation-positive locally advanced or Metastatic Non-squamous NSCLC as well as the its difference in efficacy of various EGFR mutation subtypes.
Conditions
Interventions
- DRUG
-
Osimertinib Mesylate Tablets
Osimertinib 80mg oral administration daily until progression or occurring intolerable treatment-related toxic effects or patients withdrawing informed consent(Based on whichever occurs first)
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-26
- Primary Completion
- 2020-12-31
- Completion
- 2020-12-31
Countries
- China
Study Locations
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