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Comparing Osimertinib with or without Chemotherapy for EGFR-Mutated Lung Cancer

Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients

Observational PrECOG, LLC. · NCT06538038

This study is trying to see if taking osimertinib alone or with chemotherapy helps people with EGFR-mutated lung cancer in real-life situations.

Quick facts

Study typeObservational
Enrollment538 (estimated)
Ages18 Years and up
SexAll
SponsorPrECOG, LLC. Academic / other
Drugs / interventionsosimertinib, chemotherapy, immunotherapy, radiation
Locations146 sites (Birmingham, Alabama and 145 other locations)
Trial IDNCT06538038 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect real-world data on patients with EGFR-mutated non-small cell lung cancer (NSCLC) who are treated with osimertinib, either alone or in combination with chemotherapy. The study will recruit patients from various academic and community practice sites to assess the safety and effectiveness of these treatment regimens in routine clinical practice. By analyzing outcomes from a diverse patient population, the study seeks to enhance understanding of how these therapies perform outside of controlled clinical trial settings.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with advanced EGFR-mutated non-small cell lung cancer who are receiving standard of care treatment.

Not a fit: Patients with non-sensitizing mutations in EGFR or those not diagnosed with advanced NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of osimertinib and chemotherapy for patients with EGFR-mutated NSCLC, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies have shown success in evaluating real-world outcomes for similar treatment approaches, indicating that this methodology is both relevant and valuable.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 145 other locations

+96 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non Small Cell Lung CancerEpidermal Growth Factor Receptor Gene MutationStage III Lung CancerStage IV Lung CancerOsimertinibCisplatinCarboplatinPemetrexed
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.