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Recruiting
NCT07028489
Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
Conditions: Non Small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 130
Sponsor: N-Power Medicine
Location: Pacific Cancer Care Monterey California
Summary
The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. Patients who enroll prior to initiation of osimertinib treatment (\~30%) will undergo imaging with standardized intervals.
Eligibility Criteria
INCLUSION CRITERIA
* Be ≥18 years of age at the time of informed consent
* Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later.
EXCLUSION CRITERIA
* ECOG≥2 at diagnosis of advanced or metastatic NSCLC
* Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP.
Source: ClinicalTrials.gov (NCT07028489). StuddyBuddy aggregates publicly available trial information.