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SRS Sequential Sindilimab in Brain Metastasis of NSLSC

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04180501
Enrollment
25
Registered
2019-11-27
Start date
2019-11-30
Completion date
2021-12-31
Last updated
2019-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, NSCLC Stage IV, Sintilimab, SRS

Brief summary

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

Interventions

COMBINATION_PRODUCTSRS 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.

Sponsors

Xiaorong Dong
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
iPFSof NSCLC patients receiving SRS sequential sintilimab1 yearFrom 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).

Countries

China

Contacts

Primary Contactxiaorong dong, Dr
zrg27@163.com15071116896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026