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

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

NCT ID: NCT06538038

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

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cisplatin
Carboplatin
Pemetrexed
Osimertinib

Conditions: Keywords:
Osimertinib
Cisplatin
Carboplatin
Pemetrexed
EGFR Mutated

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Drug
Intervention name: Osimertinib
Description: 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.
Arm group label: Group 1

Other name: Tagrisso

Intervention type: Drug
Intervention name: Osimertinib + Chemotherapy
Description: 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.
Arm group label: Group 2

Other name: Tagrisso, Cisplatin, Carboplatin, Pemetrexed

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. Patient Reported Outcomes (PROs) will be done 1-3 times per 15 week data capture period.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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. - Patient must not have received any prior treatment with an EGFR TKI agent. 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. - Patient must not be participating in EA5182 or any other treatment trial. Osimertinib +/- chemotherapy must be given as first-line treatment and 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. - Patient must have the ability to understand and willingness to sign IRB-approved consent for data collection and study-related analyses. This is not a treatment trial.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Miami Valley Hospital North

Address:
City: Englewood
Zip: 45415
Country: United States

Status: Recruiting

Contact:
Last name: Micah Brunello

Phone: 937-438-7819
Email: mnbrunello@premierhealth.com

Facility:
Name: JPS Oncology & Infusion Center

Address:
City: Fort Worth
Zip: 76104
Country: United States

Status: Recruiting

Contact:
Last name: Lindsay Reynolds

Phone: 817-702-0907
Email: lreynold01@jpshealth.org

Facility:
Name: Mercyhealth Hospital and Cancer Center - Janesville

Address:
City: Janesville
Zip: 53548
Country: United States

Status: Recruiting

Contact:
Last name: Ashli Huppert

Phone: 608-756-6695
Email: ahuppert@mhemail.org

Start date: September 17, 2024

Completion date: August 2029

Lead sponsor:
Agency: PrECOG, LLC.
Agency class: Other

Collaborator:
Agency: ECOG-ACRIN Cancer Research Group
Agency class: Other

Source: PrECOG, LLC.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06538038