SRS Sequential Sindilimab in Brain Metastasis of NSLSC

NCT04180501 | Unknown Phase 2

• 1 other identifier: sintilimab
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

NSCLC Stage IV; Brain Metastases; SRS; Sintilimab

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SRS sequential sintilimab

EXPERIMENTAL

Combination Product: SRS sequential sintilimab

Interventions

SRS sequential sintilimab COMBINATION_PRODUCT

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

SRS sequential sintilimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who toke major surgery within 4 weeks prior to enrollment or had ununited wounds
• Patients with hemorrhage in intracranial metastasis

Sponsors & Collaborators

• Xiaorong Dong: lead

Study Sites (1)

Union hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

xiaorong dong, Dr

CONTACT

15071116896; zrg27@163.com

Study Design

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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 27, 2019
• Study Start: November 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

CN (1)