To hear about similar clinical trials, please enter your email below
Trial Title:
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance
NCT ID:
NCT06634667
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
third-generation EGFR-TKI combined with anlotinib
Description:
third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6
cycles of chemotherapy and immunotherapy until progressive disease.
Arm group label:
The experimental cohort
Summary:
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.
Detailed description:
This prospective interventional clinical study aims to evaluate the efficacy and safety
of third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4-6
cycles of chemotherapy and immunotherapy in patients with advanced NSCLC who developed
small cell transformation after EGFR-TKI resistance.Approximately 30 non-small cell lung
cancer patients who developed small cell transformation after EGFR-TKI resistance were
enrolled and treated with 4-6 cycles of chemotherapy plus immunotherapy followed by
maintenance therapy with third-generation EGFR-TKI combined with anlotinib.The study is
expected to commence recruitment in mainland China in about November 2024. It is expected
that the trial will end in December 2026.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
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.
Exclusion Criteria:
-
1. History of other malignant tumors within 2 years.
-
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.
-
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.
-
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.
-
10. Women who are breastfeeding or pregnant.
-
11. Hypersensitivity to the test drug and the ingredients.
-
12. Other conditions assessed by the investigator to be unsuitable for
participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yongchang Zhang
Address:
City:
Changsha
Zip:
410013
Country:
China
Contact:
Last name:
Yongchang Zhang, MD
Phone:
+8613873123436
Phone ext:
+8613873123436
Email:
zhangyongchang@csu.edu.cn
Investigator:
Last name:
Yongchang Zhang, MD
Email:
Principal Investigator
Start date:
November 30, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Hunan Province Tumor Hospital
Agency class:
Other
Source:
Hunan Province Tumor Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06634667
