Outcomes With Immune Checkpoint Inhibitor for Patients With Non-Small-Cell Lung Cancer and Stable Brain Metastases

Completed

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: immune therapy

• Registration Number: NCT05129202
• Lead Sponsor: Hunan Province Tumor Hospital

Brief Summary

Non-small cell lung cancer patients may have brain metastases at diagnosis. Patients with brain metastasis may contribute as poor prognosis factors. This trial aims to explore the efficacy and the safety of immune checkpoint inhibitors in non small cell lung cancer patients with initial brain metastasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-03
• Primary Completion: 2021-09-05
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Study Completion: 2022-10-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-07
• Last Update Posted: 2023-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs

Exclusion Criteria

• 1.Patients with a clear driver mutation that can be targeted for first-line treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
immuntherapy	immune therapy	patients treated with immune checkpoint inhibitor monotherapy or combination therapy.

Primary Outcome Measures

Name	Time	Method
ORR	November 2017- October 2021	disease remission rate
PFS	November 2017- October 2021	progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	November 2017- October 2021	Overall survival

Trial Locations

Locations (1)

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China