Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases

Anlotinib Hydrochloride Combined With Whole Brain Radiotherapy for the Treatment of Brain Metastases in Small Cell Lung Cancer

The objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer

Study Overview

• Status: Active, not recruiting
• Conditions: Whole Brain Radiotherapy
• Intervention / Treatment: Drug: Antirotinib hydrochloride

Detailed Description

This was a single-center, single-arm trail. Enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. Patients with brain metastases at first visit or during treatment were treated with whole brain radiotherapy combined with anlotinib hydrochloride. Oral antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for 1 week after 2 weeks. After radiotherapy, antirotinib was continued until tumor progression. Efficacy and toxicity data were collected for evaluation and analysis.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Cancer Hospital Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Small cell lung cancer confirmed by pathology, completion of at least 4 cycles of first-line chemotherapy, and measurable disease according to RECIST criteria.
2. The expected survival time is more than 3 months.
3. Intracranial metastases ≤10.
4. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Patients who have used antiangiogenic drugs within the previous 1 month.
2. Non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer).
3. Small cell lung cancer with hilar invasion or hemoptysis.
4. Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage.
5. An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.
6. Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.
7. Patients with life-threatening conditions of other severe and/or uncontrolled diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib hydrochloride; Subjects received antirotinib hydrochloride capsules, 1 capsule (12mg) once a day.	Drug: Antirotinib hydrochloride; Oral antirotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression; Other Names: Anlotinib hydrochloride + Brain radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracranial progression-free survival	Time from enrollment to intracranial tumor progression or death	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	The time from enrollment to death from any cause was calculated as the time of death. For participants who were lost to follow-up, the time of death was usually the time of the last follow-up.	1 year
progression-free survival	The time from enrollment to tumor progression (any aspect) or death from any cause	6 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Chair: Lei Deng, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): June 10, 2024
• Study Completion (Estimated): July 30, 2025

Study Registration Dates

• First Submitted: September 22, 2024
• First Submitted That Met QC Criteria: September 22, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Brain Neoplasms
• Other Study ID Numbers: NCC2766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No