RecruitingNot applicableNCT06538038

Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.

Checked against the public recordLast updated Mar 27, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhaseNot applicable
U.S. locations146
SponsorPrECOG, LLC.
01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
PrECOG, LLC.
Interventions being studied
Drug: Osimertinib; Drug: Osimertinib + Chemotherapy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC). * Patient must have advanced disease, defined as IIIB (not amenable to definitive multi-modality therapy), IIIC, or IV (includes local or distant recurrent disease after a prior diagnosis of Stage I-III disease). All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria. * Patient tumor must have somatic activating sensitizing mutation in EGFR (e.g., but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Plasma, cytology, or tumor tissue can be utilized for standard of care mutation testing. * Prior chemotherapy and/or immunotherapy administered as primary treatment for NSCLC before EGFR mutation was identified is allowed ≤ 45 days of study registration to allow for return of sequencing information. * Prior treatment with osimertinib administered as primary treatment for NSCLC is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed). * Patient must not be participating in EA5182 or any other cancer treatment trial. Osimertinib or osimertinib + chemotherapy/immunotherapy given as first-line treatment for this disease cannot be given as part of a clinical trial. * Patients that have received prior radiation therapy in any setting for this disease are eligible. * Adults age ≥ 18 years.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Alabama at BirminghamBirmingham, Alabama
  • Mercy Clinic Fort Smith CommunitiesFort Smith, Arkansas
  • Mercy ResearchFort Smith, Arkansas
  • Fowler Family Cancer Center - JonesboroJonesboro, Arkansas
  • Stanford Cancer Center EmeryvilleEmeryville, California
  • Stanford Cancer Institute Palo AltoPalo Alto, California
  • Stanford Cancer Center South BaySan Jose, California
  • John Muir HealthWalnut Creek, California
  • BayhealthDover, Delaware
  • Satellite of Bayhealth SussexMilford, Delaware
  • Sibley Johns Hopkins UniversityWashington D.C., District of Columbia
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler: Liberty County Cancer CareHinesville, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 27, 2026. Always confirm current availability with the study team.

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