SRS Sequential Sindilimab in Brain Metastasis of NSLSC

Phase 2

• Conditions: Sintilimab; Brain Metastases; NSCLC Stage IV; SRS
• Interventions: Combination Product: SRS sequential sintilimab

• Registration Number: NCT04180501
• Lead Sponsor: Xiaorong Dong

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Study First Posted: 2019-11-27
• Last Update Posted: 2019-11-27
• Primary Completion: 2021-09
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SRS sequential sintilimab	SRS sequential sintilimab	-

Primary Outcome Measures

Name	Time	Method
iPFSof NSCLC patients receiving SRS sequential sintilimab	1 year	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).

Trial Locations

Locations (1)

Union hospital; 🇨🇳 Wuhan, Hubei, China