Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer

Официальное название

A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination With Docetaxel in Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy

Обзор

A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination with Docetaxel in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy

Подробное описание

This is a singble arm, open label, phase 2 study to evaluate safety and preliminary efficacy for Nelmastobart 800mg and docetaxel 75mg/m2 combination regimen for both AGA negative and positive NSCLC patients who have failed at least 1 line of platinum based chemotherapy.

Вмешательства

• Препарат Nelmastobart and Docetaxel
  Nelmastobart 800mg and Docetaxel 75mg/m2

Первичные конечные точки

• Progression free survival by central reviewer [Срок оценки: up to 3 years]

Вторичные конечные точки (9)

• Overall survival [Срок оценки: up to 3 years]
• Progression Free Survival assessed by Investigator [Срок оценки: Up to 3 years]
• Objective response rate, ORR [Срок оценки: Up to 3 years]
• Disease control rate, DCR [Срок оценки: Up to 3 years]
• Duration of Response [Срок оценки: Up to 3 years]
• Progression free survival rate [Срок оценки: 6 month]
• Cmax [Срок оценки: 3 weeks]
• Area under concentration-time curve [Срок оценки: 15 weeks]
• Adverse event [Срок оценки: time from the date of the first dose of study drug until 30 days after last dose]

Критерии участия

Критерии включения

• Histologically or cytologically confirmed stage IIIb, IIIc, or IV recurrent NSCLC
• BTN1A1 TPS score ≥50
• Subjects with positive AGA must have progressed after At least 1 platinum-based chemotherapy and/or immunotherapy AND at least 1 locally approved targeted therapy appropriate to the AGA
• Subjects with negative AGA must have progressed after prior PD1/ (PDL therapy and/or at least 1platinum-based chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 1.
• Adequate organ function as described in the protocol
• Adequate cardiac function as described in the protocol
• For female or male patients with reproductive potential: Agree to use contraception throughout the study and at least 5 months after the last dose.
• Life expectancy of at least 3 months
• Has agreed to provide archival tissue

Критерии исключения

• Known hypersensitivity to the active ingredients or excipients of the study drug.
• History of using Docetaxel for palliative therapy.
• Prior treatment with Cytotoxic chemotherapy or oral targeted therapy within 14 days.
• Investigational drugs within 5 half-lives.
• Monoclonal antibodies or ADCs within 4 weeks.
• Use or expected use of strong CYP3A4 inhibitors (e.g., ketoconazole) within 14 days prior to the first dose.
• Uncontrolled severe infection requiring IV treatment, or suspected infectious complications/fever.
• Requirement for continuous high-dose steroids (>10 mg/day prednisone equivalent) or immunosuppressants within 7 days (excluding Docetaxel premedication; intermittent/replacement therapies allowed).
• Pregnant or breastfeeding women.
• History of autoimmune disease requiring systemic treatment within the last 2 years
• Known active symptomatic or radiologically unstable CNS lesions
• History of stroke, unstable angina, MI, or NYHA Class III-IV symptoms within 6 months, or current Class II.
• Systolic BP 160 mmHg or Diastolic BP 100 mmHg, or hypertensive encephalopathy.
• History of ILD, organizing/drug-induced pneumonia, or active pneumonia on screening (mild asymptomatic fibrosis requires consultation).
• Recipients of allogeneic stem cell or solid organ transplants.
• Vaccination with live or attenuated live vaccines within 30 days.
• Maligancies other than NSCLC
• Failure to recover from prior anti-cancer therapy side effects to CTCAE Grade 1
• Wide-field bone marrow radiation (>30%) within 4 weeks, or limited palliative radiation within 2 weeks.
• Major surgery within 4 weeks or incomplete recovery from surgical side effects.
• Evidence of active HBV, HCV, or HIV infection (carriers with negative viral loads/RNA may be eligible).
• Clinically unstable pleural or peritoneal effusion (stable cases after intervention are allowed).

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

South Korea · 5 центров

• The Catholic University of Korea St. Vincent's Hospital — Gyeonggi-do
• Kangbuk Samsung Hospital — Seoul
• Korea University Anam Hospital — Seoul
• Samsung Medical Center — Seoul
• Seoul National University Bundang Hospital — Seoul

Идентификаторы

NCT: NCT07306624 · STCUBE-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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