Clinical trial · Interventional
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
A Phase I/Phase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
NCT06071013CI-TRIAL-00085003recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Gene Mutation | — | UNRESOLVED | — |
| EGFR-TKI Resistant Mutation | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nintedanib, gefitinib, erlotinib, afatinib, osimertinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nintedanib + gefitinib/erlotinib/afatinib/osimertinib
- description
- Nintedanib will administered orally twice per day Gefitinib will administered orally once daily Erlotinib will administered orally once daily Afatinib will administered orally once daily Osimertinib will administered orally once daily
- interventionNames
- Drug: Nintedanib, gefitinib, erlotinib, afatinib, osimertinib
Primary outcomes (2)
- measure
- The toxicity of combinate nintedanib and EGFR TKI
- timeFrame
- Assessed every 6 weeks of chest CT scan until PD.
- measure
- Patient objective response rate
- timeFrame
- Assessed every 6 weeks of chest CT scan
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer. 2. Positive EGFR mutations are diagenesis. 3. Participants with histologically/cytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib. 4. Participants must have adequate hepatic, renal, and bone marrow function Exclusion Criteria: 1. Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects. 2. Participants have known hypertension, and chronic liver and gastrointestinal disease. 3. Participants have known brain metastasis. 4. Female participants who are pregnant or breast-feeding 5. Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).
References
Publications (0)
Data not yet available
No reference posted for this study.