NCT06071013RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Sept 2023
- Start date
- Feb 2024
- Primary completion date
- Aug 2026
- Lead sponsor
- China Medical University Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06071013
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From Feb 2024 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants have known hypertension, and chronic liver and gastrointestinal disease.
Lab values
- Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.
Other
- Participants have known brain metastasis.
- Female participants who are pregnant or breast-feeding
- Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).
Who the study is looking for
- Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.
- Positive EGFR mutations are diagenesis.
- 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.
- Participants must have adequate hepatic, renal, and bone marrow function
Age in the registry: 20 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.