NCT06634667Not yet recruitingPhase 2
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance
Efficacy and Safety of Third-generation EGFR-TKI Combined With Anlotinib as Maintenance Therapy Following 4-6 Cycles of Chemotherapy and Immunotherapy in NSCLC With Small Cell Transformation After EGFR-TKI Resistance: a Single-arm Prospective Phase II Study
Source: ClinicalTrials.gov · Last updated 10 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Oct 2024
- Start date
- 30 Nov 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Hunan Province Tumor Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06634667
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 30 Nov 2024 to the primary completion date, 31 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.
Prior treatment
- 2\. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
- 3\. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- 8\. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
- 9\. Live vaccine was given 2 weeks before the first medication.
Other illness
- 1\. History of other malignant tumors within 2 years.
- 4\. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- 5\. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
- 6\. Heart-related diseases or abnormalities
- 7\. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
- 11\. Hypersensitivity to the test drug and the ingredients.
- 12\. Other conditions assessed by the investigator to be unsuitable for participation in the study.
Other
- 10\. Women who are breastfeeding or pregnant.
Who the study is looking for
- 1\. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- 2\. Age ≥ 18 years.
- 3\. Histopathology is confirmed non-small cell lung cancer .
- 4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.
- 5\. Predicted survival ≥ 12 weeks. .
- 6\. ECOG 0-2.
- 7\. Adequate bone marrow hematopoiesis and organ function.
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Yongchang Zhang Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.