Osimertinib as First-line Therapy for Patients With Late-stage Lung Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT03460275
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib Mesylate Tablets — DRUG
    Osimertinib 80mg oral administration daily until progression or occurring intolerable treatment-related toxic effects or patients withdrawing informed consent(Based on whichever occurs first)

Study Details

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.

Key Dates

Start date
Feb 26, 2018
Status verified
Mar 2018
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: single group
    Osimertinib Mesylate Tablets 80 mg, one time a day until disease progression

Primary Outcome Measure

Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 [ Time Frame: eight weeks ]

Central Contacts

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