Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment
- Sponsor
- First Affiliated Hospital of Zhejiang University
- Study ID
- NCT04438902
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- osimertinib mesylate tablets and anlotinib hydrochloride capsules — DRUGosimertinib mesylate tablets 80mg qd and anlotinib hydrochloride capsules 10mg qd day 1-14 of a 21-day cycle
Study Details
EGFR T790M gatekeeper mutation accounts for approximately 60% of acquired resistance to the first- or second-generation EGFR-TKI treatment. Osimertinib, a third-generation EGFR TKI, has become the standard therapy for NSCLC patients with acquired EGFR T790M mutation. However, acquired resistance to osimertinib is still inevitable and there is no established targetable agent currently. Thus, treatment strategy for patients with acquire resistance to osimertinib remains an urgent issue. In this study, we aimed to evaluate the efficacy of osimertinib combined with anlotinib in acquired EGFR T790M mutated NSCLC patients with gradual progression on osimertinib treatment.
Key Dates
- Start date
- Dec 12, 2020
- Status verified
- Jun 2021
- Primary completion
- Dec 8, 2022
- Completion
- Feb 16, 2023
Study Design
- Enrollment
- 3 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: osimertinib combined with anlotinib
Primary Outcome Measure
progression-free survival (PFS) [ Time Frame: from the date of first dose of osimertinib until the date of disease progression,assessed up to 12 months. ]
Related Studies
- The Effect of Beta-glucan in Non-Small Cell Lung CancerRecruiting · University of Louisville · Louisville, Kentucky
- Dabrafenib and/or Trametinib Rollover StudyPHASE4 · Recruiting · Novartis Pharmaceuticals · Scottsdale, Arizona
- SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and RegistryRecruiting · Massive Bio, Inc. · Birmingham, Alabama
- Study of NEO-201 in Solid Tumors Expansion CohortsPHASE1/PHASE2 · Recruiting · Precision Biologics, Inc · Bethesda, Maryland