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

NCT06611657 | Active Not Recruiting Phase 2

• 1 other identifier: NCC2766
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Whole Brain Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Intracranial progression-free survival

  Time from enrollment to intracranial tumor progression or death

  6 months

Secondary Outcomes (2)

• Overall Survival

  1 year

• progression-free survival

  6 months

Study Arms (1)

Anlotinib hydrochloride

EXPERIMENTAL

Subjects received antirotinib hydrochloride capsules, 1 capsule (12mg) once a day.

Drug: Antirotinib hydrochloride

Interventions

Antirotinib hydrochloride DRUG

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

Also known as: Anlotinib hydrochloride + Brain radiotherapy

Anlotinib hydrochloride

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Study Officials

• Lei Deng, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 25, 2024
• Study Start: August 20, 2021
• Primary Completion: June 10, 2024
• Study Completion: July 30, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)