Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

Официальное название

Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS <50% Non-small Cell Lung Cancer

Обзор

Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent/metastatic PD-L1 TPS\<50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.

Подробное описание

This is a single institution, single arm, open label phase 2 study in vulnerable or older adults (Age ≥70) with recurrent or metastatic, histologically confirmed squamous cell carcinoma or non-squamous cell carcinoma of lung without driver mutation and PD-L1 TPS \< 50% to evaluate safety and tolerability of reduced dose of chemotherapy and immunotherapy.

Вмешательства

• Препарат Reduced Dose of Chemotherapy and Immunotherapy
  Eligible participants with recurrent or metastatic squamous cell carcinoma will receive 4 cycles of carboplatin area under the curve (AUC) 3 IV every 21 days and paclitaxel 135 mg/m2 intravenous (IV) every 21 days. Participants with non-squamous histology will receive carboplatin AUC 3 IV every 21 days and pemetrexed 375 mg/m2 IV every 21 days (collectively, induction chemotherapy). Both groups will receive pembrolizumab 200 mg IV every 21 days for a total of up to 35 cycles (Cycles ≥5 are colle

Первичные конечные точки

• Occurrence of chemotherapy discontinuation due to treatment-related adverse events [Срок оценки: Through completion of protocol therapy, up to 2 years]

Вторичные конечные точки (5)

• Response (complete response and partial response) per Response Evaluation Criteria in Solid Tumors [Срок оценки: Up to 5 years]
• Overall incidence and severity of all adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [Срок оценки: Time of patient consent and throughout the duration of the study, including during the treatment period and for 30 days following the final dose of the study medication, up to 2 years and 1 month]
• Overall survival defined as the time from the date of first study treatment until the date of death. Overall survival (OS) will be censored on the last date a participant was known to be alive [Срок оценки: Up to 5 years]
• Progression-free survival (PFS) measured from the date of first study treatment until the date of documented disease progression [Срок оценки: Up to 5 years]
• Cancer related symptoms and quality of life [Срок оценки: Baseline, Cycle 3 Day 1, Cycle 5 Day 1 Cycle 9 Day 1, EOT Visit (up to 2 years)]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)
• Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation
• No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.
• Age 70 or meeting frailty definition or above at the date of signing informed consent
• Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)
• PD-L1 tumor proportion score (TPS) of less than 50%
• Eastern Cooperative Oncology Group (ECOG) PS of 0-3
• Have measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment
• Absolute neutrophil count (ANC) ≥ 1,000/μL
• Platelets ≥ 75,000/μL
• Hemoglobin (Hgb) ≥ 8.0 g/dL (transfusion permitted)
• Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
• Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) /alanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN
• Ability to understand and the willingness to sign a written informed consent document

Критерии исключения

• Participants with life expectancy of less than 3 months at the time of enrollment
• Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)
• Diagnosis of interstitial lung disease
• Creatinine clearance of <30 mL/min
• Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible
• Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:

• Doses less than or equal to the equivalent of prednisone 10 mg daily
• Short courses of steroids that are discontinued prior to enrollment
• Inhaled, intranasal and/or topical steroids
• Dexamethasone taper for treating vasogenic edema associated with CNS disease

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Virginia Commonwealth University — Richmond
• VCU Health Tappahannock Hospital — Tappahannock

Идентификаторы

NCT: NCT06731413 · MCC-24-21788

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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