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

NCT06538038 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 538

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

Osimertinib

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.

DRUG

Osimertinib + Chemotherapy

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.

Sponsors & Collaborators

  • ECOG-ACRIN Cancer Research Group

    collaborator NETWORK

  • PrECOG, LLC.

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2028-08-31
Completion
2029-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06538038 on ClinicalTrials.gov