Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance

NCT06634667 | Not Yet Recruiting Phase 2

• 1 other identifier: 20241006
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month

• Adverse events (AEs) according to CTCAE 5.0

  Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month

Study Arms (1)

The experimental cohort

EXPERIMENTAL

third-generation EGFR-TKI combined with anlotinib

Drug: third-generation EGFR-TKI combined with anlotinib

Interventions

third-generation EGFR-TKI combined with anlotinib DRUG

third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6 cycles of chemotherapy and immunotherapy until progressive disease.

The experimental cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
• \. Age ≥ 18 years.
• \. Histopathology is confirmed non-small cell lung cancer .
• Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.
• \. Predicted survival ≥ 12 weeks. .
• \. ECOG 0-2.
• \. Adequate bone marrow hematopoiesis and organ function.

You may not qualify if:

• \. History of other malignant tumors within 2 years.
• \. 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.
• \. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
• \. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
• \. 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.
• \. Heart-related diseases or abnormalities
• \. 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.
• \. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
• \. Live vaccine was given 2 weeks before the first medication.
• \. Women who are breastfeeding or pregnant.
• \. Hypersensitivity to the test drug and the ingredients.
• \. Other conditions assessed by the investigator to be unsuitable for participation in the study.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Yongchang Zhang

Changsha, Hunan, 410013, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yongchang Zhang

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Liang Zeng

CONTACT

15974139200; 530490930@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 10, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

CN (1)