ClinicalTrials.gg
Active, not recruitingNCT06538038Updated Sep 9, 2026

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

An observational study in Non Small Cell Lung Cancer, Epidermal Growth Factor Receptor Gene Mutation and Stage III Lung Cancer, sponsored by PrECOG, LLC.. Active, not recruiting at 146 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by PrECOG, LLC. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

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

Keywords

  • Osimertinib
  • Cisplatin
  • Carboplatin
  • Pemetrexed
  • EGFR Mutated
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's enrollment of 200 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

PrECOG, LLC. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 11 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with EGFR-mutated NSCLC, not being treated in a clinical trial but receiving osimertinib +/- chemotherapy at academic and community practices participating in PrE1702 registry.

Eligibility criteria

Inclusion Criteria:

  • Patient must have a -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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Group 1

    Osimertinib

    Drug: Osimertinib

  • Group 2

    Osimertinib + Chemotherapy

    Drug: Osimertinib + Chemotherapy

Interventions

  • Single agent Osimertinib by mouth once daily. Dosing and administration of osimertinib will be administered as per routine standard of care per the package insert or per institutional guidelines.

    Also known as: Tagrisso

  • DrugOsimertinib + Chemotherapy

    Drug page: Osimertinib

    Osimertinib by mouth once daily + Chemotherapy. Chemotherapy choice will be per treating physician. Dosing and administration of osimertinib +/- chemotherapy agents will be administered as per routine standard of care per the package insert or per institutional guidelines.

    Also known as: Tagrisso, Cisplatin, Carboplatin, Pemetrexed

06

What researchers measure

Primary outcomes

  1. real-world Progression-Free Survival (rwPFS)

    Time from initiating therapy to progression or death without documented progression

    Time frame: From initiation of therapy to progression or death, up to 3 years

Secondary outcomes

  1. real-world Overall Survival (rwOS)

    Time from initial therapy to death from any cause.

    Time frame: From initiation of therapy to death, up to 3 years

  2. real-world time to treatment discontinuation (rwTTD)

    Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib.

    Time frame: From initiation of therapy to discontinuation of osimertinib, up to 3 years

07

Study locations

146 sites

Showing the first 100 of 146 sites. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No — Data is proprietary.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06538038
Lead sponsor
PrECOG, LLC.
Responsible party
Sponsor
First posted
Aug 5, 2024
Start date
Sep 17, 2024
Primary completion
Aug 2028 (estimated)
Completion
Aug 2029 (estimated)
Last update
Sep 9, 2026

Study contacts

Suzanne Cole, MD
study chair · UT Southwestern Simmons Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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