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

ConditionNSCLC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHunan Province Tumor Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

Central nervous system (CNS) progression-free survival

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

Time frame
2 years
2

Objective Response Rate

Defined as the number (%) of patients with response of Complete Response or Partial Response

Time frame
2 years

Other outcomes

Sponsors and contacts

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