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

Recruiting

• Conditions: Non Small Cell Lung Cancer; Epidermal Growth Factor Receptor Gene Mutation; Stage III Lung Cancer; Stage IV Lung Cancer
• Interventions: Drug: Osimertinib; Drug: Osimertinib + Chemotherapy

• Registration Number: NCT06538038
• Lead Sponsor: PrECOG, LLC.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-07-31
• Study First Submitted QC: 2024-07-31
• Study First Posted: 2024-08-05
• Study Start: 2024-09-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-30
• Last Update Posted: 2025-07-01
• Primary Completion: 2028-08
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 538

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Osimertinib	Osimertinib
Group 2	Osimertinib + Chemotherapy	Osimertinib + Chemotherapy

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
real-world Overall Survival (rwOS)	From initiation of therapy to death, up to 3 years	Time from initial therapy to death from any cause.
real-world time to treatment discontinuation (rwTTD)	From initiation of therapy to discontinuation of osimertinib, up to 3 years	Time from treatment initiation (osimertinib or osimertinib + chemotherapy) to discontinuation of osimertinib.

Trial Locations

Locations (114)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Mercy Clinic Fort Smith Communities; 🇺🇸 Fort Smith, Arkansas, United States

Mercy Research; 🇺🇸 Fort Smith, Arkansas, United States

Fowler Family Cancer Center - Jonesboro; 🇺🇸 Jonesboro, Arkansas, United States

John Muir Health; 🇺🇸 Walnut Creek, California, United States

Bayhealth; 🇺🇸 Dover, Delaware, United States

Satellite of Bayhealth Sussex; 🇺🇸 Milford, Delaware, United States

Advocate Good Shepherd Hospital; 🇺🇸 Barrington, Illinois, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

John H Stroger Jr Hospital of Cook County; 🇺🇸 Chicago, Illinois, United States

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