Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib [Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until date of progression or date of death whichever comes first, assessed up to 100 months)]
Secondary outcome measures (2)
- Assess overall survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib [Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until death, as assessed up to 100 months]
- Assess time to treatment discontinuation in patients with locally advanced or metastatic NSCLC treated with first line osimertinib [Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until treatment discontinuation, as assessed up to 100 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Pacific Cancer Care — Monterey
- Torrance Memorial Physician Network-Cancer Care — Torrance
- John Muir Health — Walnut Creek
- Bayhealth Cancer Center- Kent — Dover
- Bayhealth Cancer Center- Sussex — Milford
- Kootenai Clinic Cancer Services Coeur d'Alene — Coeur d'Alene
- Northwest Oncology & Hematology — Elk Grove Village
- Lankenau Medical Center — Paoli
- … and 1 more center
Identifiers
NCT: NCT07028489 · NPM-002