NCT06762327Not yet recruitingPhase 2
Ensartinib in the Treatment of ALK Positive or MET Exon 14 Skipping Anvanced Solid Tumors Excluded Lung Cancer
Source: ClinicalTrials.gov · Last updated 7 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In lung cancer, ensartinib is effective in improving the prognosis of ALK positive /MET exon 14 skipping patients. However, patients with ALK positive /MET14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. We hope to bring a new effective and safe treatment option to these patients more efficiently.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 23 Dec 2024
- Start date
- 28 Feb 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Diseases
- Lung cancer
- NCT number
- NCT06762327
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 28 Feb 2025 to the primary completion date, 30 Dec 2026
- No sites listed in no 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.
Prior treatment
- Active viral, bacterial, or fungal infection detected 2 weeks before enrollment
- receiving medications or herbal supplements with potent inducers of CYP3A4 (at least 3 weeks prior)
- Interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease
Other illness
- Any severe or uncontrolled systemic illness, including uncontrolled Hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)
- Ineligible cardiac function
Other
- Pregnancy or lactation
- Lack of adequate bone marrow reserve or organ function
Who the study is looking for
- Advanced/metastatic solid tumors other than primary lung cancer
- Alk-positive or MET14 exon skipping mutation by IHC\\FISH\\NGS\\RT-PCR
- Have no standard treatment after MDT discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment
- Adequate liver and kidney function
- Adequate bone marrow function
- ECOG PS 0-3
- Female subjects should not be pregnant. All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications Written informed consent provided
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.