Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| third-generation EGFR-TKI combined with anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- The experimental cohort
- description
- third-generation EGFR-TKI combined with anlotinib
- interventionNames
- Drug: third-generation EGFR-TKI combined with anlotinib
Primary outcomes (1)
- measure
- progression-free survival (PFS)
- timeFrame
- Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
- description
- PFS was defined as the duration from the start of standard chemotherapy plus immunotherapy to disease progression or last follow up
Secondary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available