About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
third-generation EGFR-TKI combined with anlotinib
Drugthird-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6 cycles of chemotherapy and immunotherapy until progressive disease.
Treatment groups
Trial outcomes
Primary outcomes
progression-free survival (PFS)
PFS was defined as the duration from the start of standard chemotherapy plus immunotherapy to disease progression or last follow up
Secondary outcomes
Objective Response Rate (ORR)
To assess overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Adverse events (AEs) according to CTCAE 5.0
Number of participants with adverse events (AEs) according to CTCAE 5.0
Sponsors and contacts
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