Clinical trial · Observational
Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
NCT07028489CI-TRIAL-00118239recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Osimertinib plus chemo, or other regimens
- description
- Osimertinib plus chemo, or other regimens in the metastatic setting initiated on or after January 1, 2024
- label
- Osimertinib monotherapy
- description
- Osimertinib monotherapy for newly diagnosed mNSCLC
Primary outcomes (1)
- measure
- Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
- timeFrame
- 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 outcomes (2)
- measure
- Assess overall survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.