A Study With Central Nervous System Metastatic EGFR Mutation Positive Non-small Cell Lung Cancer

NCT05991193 | Recruiting

• 1 other identifier: FORCE RWS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.

  2 years

Secondary Outcomes (2)

• Central nervous system (CNS) progression-free survival

  2 years

• Objective Response Rate

  2 years

Eligibility Criteria

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

Study Population

Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.

You may qualify if:

• Patients must be ≥18 years.
• Provision of fully informed consent prior to any study specific procedures.
• Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together.
• Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).
• According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

You may not qualify if:

• None

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

needle biopsy for samples with DNA

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Deputy Director of Thoracic Oncology Department

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 14, 2023
• Study Start: December 29, 2023
• Primary Completion: August 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

CN (1)