UPCC 28524 PrE1702 Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients

Study on Treatments for EGFR-Mutated Non-Small Cell Lung Cancer

Enrolling By Invitation
18 years or above
All
Phase N/A
538 participants needed
1 Location

Brief description of study

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.

Detailed description of study

This study tests the feasibility of using real-world data collection through the recruitment of well-characterized patients into a registry, spanning academic and community practice sites to determine patient outcomes in all-comers. The scientific community would further benefit from a greater understanding of the safety and effectiveness of newly approved therapies prescribed in routine clinical practice.

Non-interventional (observational) study with 250 participants per exposure group (maximum accrual up to 538 total participants) comparing outcomes in patients with EGFR-mutated NSCLC, not being treated in a clinical trial but receiving standard of care osimertinib +/- chemotherapy.

The treating physician determines whether a patient will receive standard of care single agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded at registration.

Clinical/Imaging assessments will be per the treating physician.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Non Small Cell Lung Cancer, Epidermal Growth Factor Receptor Gene Mutation, Stage III Lung Cancer, Stage IV Lung Cancer
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the safety and effectiveness of standard care treatments in patients with a type of lung cancer known as Epidermal Growth Factor Receptor (EGFR)-mutated Non-Small Cell Lung Cancer (NSCLC). The purpose of this study is to observe patients who are receiving standard care treatments, which may include a medication called osimertinib, with or without chemotherapy, outside of a clinical trial setting. An observational study is a type of research study where data is collected by observing participants receiving routine care, without changing their treatment, which may focus on people using specific medications or having certain conditions to better understand how treatments work.

Participants in this study will be observed for their outcomes while receiving their usual care as determined by their treating physician. The study will involve collecting data from 250 participants in each treatment group, with a total of up to 538 participants. The treatments and assessments will be conducted according to the usual practices of the treating physicians, and no additional interventions will be made as part of the study.

  • Who can participate: Adults aged 18 years or older with a confirmed diagnosis of non-small cell lung cancer (NSCLC) and advanced disease are eligible. Participants must have specific mutations in the EGFR gene and should not be part of another cancer treatment trial.
  • Study details: Participants will receive standard of care treatment as determined by their physician. This may involve the use of osimertinib alone or in combination with chemotherapy. The study will observe and record the outcomes of these treatments.
Updated on 27 Mar 2026. Study ID: 25-0137
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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