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Observational Study of Osimertinib for EGFR-Mutated NSCLC

This study is looking at how well osimertinib, with or without chemotherapy, works in real-world settings for people with advanced non-small cell lung cancer (NSCLC) that has an EGFR gene mutation. This is an observational study, meaning you would receive standard care from your doctor, and the study would collect information about your treatment and health. The study aims to understand the safety and effectiveness of these treatments. You might be able to join if you are 18 or older, have advanced NSCLC (Stage IIIB, IIIC, or IV), and have an EGFR gene mutation. The main goal is to see how long people live without their cancer getting worse (Progression-Free Survival) for up to three years. The study plans to include up to 538 participants.

Study design
This is an observational study, not a clinical trial where treatments are assigned. It will gather information from up to 538 participants receiving standard care with osimertinib +/- chemotherapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track how long participants live without their cancer getting worse for up to three years from when they start treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06538038

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

Recruiting
Not specifiedAges 18+Observational
PrECOG, LLC.
~538 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:OsimertinibOsimertinib + Chemotherapy

At a glance

Recruiting sites
146 of 146 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
real-world Progression-Free Survival (rwPFS)
Measured over From initiation of therapy to progression or death, up to 3 years

Conditions

Non Small Cell Lung Cancer
Epidermal Growth Factor Receptor Gene Mutation
Stage III Lung Cancer
Stage IV Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

146 sites across 22 states
Wisconsin30
Minnesota24
Illinois16
Pennsylvania15
New Jersey8
Mississippi7
Ohio6
Missouri5

Study leadership

  • Suzanne Cole, MD · STUDY_CHAIR · UT Southwestern Simmons Comprehensive Cancer Center

Who to contact

Karen Fitzpatrick, RN
[email protected]
215-439-2294
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • real-world Progression-Free Survival (rwPFS)From initiation of therapy to progression or death, up to 3 years

    Time from initiating therapy to progression or death without documented progression