A Single-arm Pilot Study of Tislelizumab Combined With Anlotinib in Patients With Advanced NSCLC With Driver-negative After Progression to Immunotherapy

Обзор

Immune resistance after treatment, there is no standard treatment, one of the most important and the most effective measures is immune to combination therapy。Targeted angiogenesis therapy has always been the focus of research on the treatment of NSCLC patients with progressive disease after immunotherapy. From the mechanism of action, angiogenesis and immunosuppression are interrelated processes.

Вмешательства

• Препарат Tislelizumab
  200mg iv D1 Q3W
• Препарат Anlotinib
  Anlotinib 12mg D1-12 Q3W

Первичные конечные точки

• objective response rate [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months]

Вторичные конечные точки (4)

• progression free survival time [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months]
• over survival time [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to18 months]
• disease control rate [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months]
• safety including any grade adverse events [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months]

Критерии участия

Критерии включения

• voluntary participation in clinical research; Fully understand and Informed the study and sign the Informed Consent Form (ICF); Be willing to follow and be able to complete all trial procedures;
• age of 18-75 years old (including boundary value), regardless of gender;
• Pathologically confirmed locally advanced, metastatic non-small cell lung cancer (NSCLC), including squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. Patients with non-squamous non-small cell lung cancer should exclude known EGFR mutation or ALK gene rearrangement.
• patients with resistance to first-line PD-(L)1 inhibitors combined with chemotherapy;
• patients with tumor response of CR/PR/SD after at least one first-line immunotherapy;
• Subjects' ECOG PS score was 0-1 (including boundary value);
• Patients had to have ≥1 measurable lesion (according to RECIST1.1 criteria).
• predicted survival time ≥6 months;

Критерии исключения

• Frontline treatment with anlotinib, anti-angiogenic macromolecular monoclonal antibody or other small molecule TKI drugs;
• central lung cancer with large blood vessel invasion;
• patients with any signs or history of bleeding that may affect treatment according to the investigator's judgment; Patients with bleeding events ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures within 4 weeks before the first dose of study drug;
• hemoptysis > 50ml/d;
• inability to swallow capsules or diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, gastric or small bowel resection, bariatric surgery, inflammatory bowel disease, partial or complete intestinal obstruction;
• Poorly controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg)
• other known malignant tumors that are developing or require active treatment;
• Currently participating or has participated in the clinical research of other drugs;
• interstitial lung disease or (non-infectious) pneumonia requiring steroid therapy

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06356675 · A single-arm pilot

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗