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

Sponsor

Hunan Province Tumor Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05129202

Collaborator

(none)

200

Enrollment

Location

58.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: immune therapy

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Nov 3, 2017

Actual Primary Completion Date :

Sep 5, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Chemotherapy alone or chemotherapy combined with anti-angiogenesis patients with Chemotherapy
immuntherapy patients treated with immune checkpoint inhibitor monotherapy or combination therapy.	Drug: immune therapy The patient receives immunotherapy

Arm

Intervention/Treatment

Chemotherapy alone or chemotherapy combined with anti-angiogenesis

patients with Chemotherapy

immuntherapy

patients treated with immune checkpoint inhibitor monotherapy or combination therapy.

Drug: immune therapy

The patient receives immunotherapy

Outcome Measures

Primary Outcome Measures

ORR [November 2017- October 2021]
disease remission rate
PFS [November 2017- October 2021]
progression free survival

Secondary Outcome Measures

OS [November 2017- October 2021]
Overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis

Treated with ICIs

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Cancer Hospital	Changsha	Hunan	China	410013

Sponsors and Collaborators

Hunan Province Tumor Hospital

Investigators

Principal Investigator: Yongchang C Zhang, MD, Hunan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yongchang Zhang, Director, Head of Medical Oncology, Principal Investigator, Clinical Professor, Hunan Province Tumor Hospital

ClinicalTrials.gov Identifier:

NCT05129202

Other Study ID Numbers:

OMESIA

First Posted:

Nov 22, 2021

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Brain Neoplasms

Study Results

No Results Posted as of Jan 20, 2022