Clinical trial NCT06634667: Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
measure: Adverse events (AEs) according to CTCAE 5.0
timeFrame: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
Other outcomes:
Locations:
city: Changsha
country: China
facility: Yongchang Zhang
state: Hunan
Study officials:
References: