SRS Sequential Sindilimab in Brain Metastasis of NSLSC

Brain Metastases Clinical Trial

Official title:

A Phase II Study on the Treatment of Advanced Non-small Cell Lung Cancer With Brain Metastasis by SRS Sequential Sintilimab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180501
• Other study ID #: sintilimab
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2019
• Est. completion date: December 2021

Study information

• Verified date: November 2019
• Source: Wuhan Union Hospital, China
• Contact: xiaorong dong, Dr
• Phone: 15071116896
• Email: zrg27[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase II study on the treatment of advanced non-small cell lung cancer with brain metastasis by SRS sequential sintilimab

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• non-small cell lung cancer patients with less than brain metastases

• Patients must have received at least the first-line anti-tumor treatment, and the front-line treatment must include chemotherapy or targeted treatment with a platinum containing combination scheme, but not anti-PD-1 / L1 treatment

• Patients who have not received intracranial local treatment before

Exclusion Criteria:

• Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds

• Patients with hemorrhage in intracranial metastasis

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• NSCLC Stage IV
• Sintilimab
• SRS

Intervention

Combination Product:
• SRS sequential sintilimab
The subjects first received a targeted radiotherapy of SRS, and started the treatment of sintilimab per 3 weeks within 35 days after SRS.

Locations

Country	Name	City	State
China	Union hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiaorong Dong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iPFSof NSCLC patients receiving SRS sequential sintilimab	From the beginning of treatment to the end of follow-up study, when the longest diameter of brain metastases treated by SRS was more than 30% smaller than the baseline level at any time of efficacy evaluation, the objective remission of the lesions was achieved. The time from the objective remission to the next progress of the intracranial lesions was recorded as the intracranial progression-free survival(iPFS).	1 year