Clinical trial · Interventional
Osimertinib Combined With Anlotinib in EGFR T790M Mutated NSCLC Patients With Progression on Osimertinib Treatment
A Prospective, Multi-center, Interventional Study of Osimertinib Combined With Anlotinib in Acquired EGFR T790M Mutated NSCLC Patients With Gradual Progression on Osimertinib Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Many patients can't tolerate the combination treatment due to adverse events.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| osimertinib mesylate tablets and anlotinib hydrochloride capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- osimertinib combined with anlotinib
- interventionNames
- Drug: osimertinib mesylate tablets and anlotinib hydrochloride capsules
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- from the date of first dose of osimertinib until the date of disease progression，assessed up to 12 months.
- description
- PFS is defined as the time from beginning of osimertinib to disease progression on combination treatment of osimertinib and anlotinib.
Secondary outcomes (3)
- measure
- Objective Response Rate (ORR)
- timeFrame
- from the date of combination of osimertinib and anlotinib, assessed up to 6 weeks.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ability to provide informed consent, complete all study assessments and have complete medical record. 2. Age:18-75 years. 3. Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC. 4. Patients should be confirmed acquired EGFR T790M mutation and received osimertinib as the second line treatment, and they should have the following: (1) benefit from treatment with osimertinib initially ;(2) gradual progression on osimertinib treatment as defined by minor increment of tumor burden (≥10% but \<20% in the sum of target lesions). 5. At least one measurable lesion as defined by lesions ≥10mm in long axis according to RECIST 1.1. Exclusion Criteria: 1. Patients who will be or were involved in any other interventional antitumour clinical studies for locally advanced/metastatic NSCLC currently or previously. 2. Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer). 3. Patients at risk of bleeding. 4. Patients with renal dysfunction. 5. Uncontrolled severe hypertension. 6. Any concomitant condition evaluated by physicians which is not suitable for osimertinib or anlotinib treatment.
References
Publications (0)
Data not yet available