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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• real-world Progression-Free Survival (rwPFS) [Срок оценки: From initiation of therapy to progression or death, up to 3 years]

Вторичные конечные точки (2)

• real-world Overall Survival (rwOS) [Срок оценки: From initiation of therapy to death, up to 3 years]
• real-world time to treatment discontinuation (rwTTD) [Срок оценки: From initiation of therapy to discontinuation of osimertinib, up to 3 years]

Критерии участия

Критерии включения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 146 центров

• University of Alabama at Birmingham — Birmingham
• Mercy Clinic Fort Smith Communities — Fort Smith
• Mercy Research — Fort Smith
• Fowler Family Cancer Center - Jonesboro — Jonesboro
• Stanford Cancer Center Emeryville — Emeryville
• Stanford Cancer Institute Palo Alto — Palo Alto
• Stanford Cancer Center South Bay — San Jose
• John Muir Health — Walnut Creek
• … и ещё 138 центров

Идентификаторы

NCT: NCT06538038 · PrE1702

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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