A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL)

Официальное название

A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan

Обзор

The goal of this observational study is to learn about the effectiveness of Nivolumab in combination with chemotherapy as Neoadjuvant therapy for patients with non-small cell lung cancer (NSCLC). The main question it aims to answer is: Does patient with NSCLC in treatment of Nivolumab combined with chemotherapy demonstrate better pCR and PFS ? Is it safe for patient with NSCLC in treatment of Nivolumab combined with chemotherapy ? The data for those participants already receiving nivolumab in combination with chemotherapy as part of their regular medical care for NSCLC will be collected within the designated collection period.

Подробное описание

Rationale :

In Taiwan, lung cancer is the most common cancer and has the highest mortality rate among the top 10 cancers, accounting for 19.4% of all cancer-related deaths in 2022. Additionally, 94.3% of lung cancer cases were diagnosed as NSCLC (n = 16,420). Based on clinical staging (per AJCC 8th edition), 2.26% of NSCLC cases were classified as stage 0, 35.75% as stage I, 3.79% as stage II, 8.80% as stage III, 41.01% as stage IV, and 8.39% had an unknown stage.25 The US Food and Drug Administration (FDA) approved nivolumab in combination with platinum-doublet chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC in March 2022 and Taiwan subsequently approved this indication in February 2023. However, the real-world effectiveness of this treatment and the NSCLC patient profile, particularly in the Taiwanese population, remains unclear, as does the patient profile for adjuvant therapy following neoadjuvant chemo-immunotherapy (chemo-IO). Therefore, this study aims to address these gaps and consolidate nivolumab's role in resectable NSCLC by bridging the data gap with real-world evidence.

Первичные конечные точки

• Pathological Complete Response (pCR) rate [Срок оценки: At least 12 months retrospectively]
• Event-free survival (EFS) [Срок оценки: At least 12 months retrospectively]
• Incidences of AE and SAE [Срок оценки: At least 12 months retrospectively]

Критерии участия

Критерии включения

• Aged 18 years and older
• Patients who are diagnosed with pathologically confirmed, non-metastatic, resectable NSCLC
• Patients who have received at least one cycle of neoadjuvant nivolumab combined with chemotherapy since the approval of the regimen in February 2023, and who have at least one imaging assessment of EFS and surgical status recorded. For patients who underwent surgery, at least one pathological report is required.
• Patients who have been followed up for at least 12 months (from first dose of neoadjuvant therapy to last medical record date at study site), exceptional case as follows:

• Patients who expired within 12 months of follow-up
• Patients who experience disease progression or recurrence but continue to follow-up
• Participants with histologically confirmed Stage II-III NSCLC (per the 8th International Association for the Study of Lung Cancer) who are considered resectable.

Критерии исключения

• Patients with distant metastasis (M1 disease according to the eighth edition of the American Joint Committee on Cancer \[AJCC\] cancer staging manual) prior to neoadjuvant therapy
• Patients with N3 disease per AJCC 8th edition
• Patients with known EGFR mutations or ALK translocation
• Patients who have received any prior systemic therapy for NSCLC
• Patients with a history of previous cancers or other concurrent malignancies within 10 years before the first dose of nivolumab

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 9 центров

• Chang Gung Memorial Hospital Kaohsiung Branch — Kaohsiung City
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
• Kaohsiung Veterns General Hospital — Kaohsiung City
• China Medical University Hospital — Taichung
• Taichung Veterans General Hospital — Taichung
• Mackay Memorial Hospital Taipei Branch — Taipei
• National Taiwan University Hospital — Taipei
• Taipei Veteran General Hospital — Taipei
• … и ещё 1 центр

Идентификаторы

NCT: NCT07169708 · R1132-NIV-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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