Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC

Официальное название

Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study

Обзор

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.

Подробное описание

This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer. The primary objective of the study is to assess the efficacy and safety of JSKN016 in combination therapy in selected subjects with advanced non-small cell lung cancer.

Вмешательства

• Препарат JSKN016
  Administered intravenously according to protocol.
• Препарат Carboplatin
  AUC 5, Q3W, administered intravenously according to protocol.
• Препарат Furmonertinib Mesylate
  160mg（cohort1A-b）or 80mg（cohort 5）, qd, administered according to protocol.
• Препарат Ivonescimab
  20mg/kg, Q3W, administered intravenously according to protocol.
• Препарат Docetaxel
  60mg/m\^2, Q3W, administered intravenously according to protocol.
• Препарат Tislelizumab
  200mg, Q3W, administered intravenously according to protocol.
• Препарат Pembrolizumab
  200mg, Q3W, administered intravenously according to protocol.

Первичные конечные точки

• ORR assessed by the investigator per RECIST v1.1 [Срок оценки: Up to 24months]
• Safety reflected by AE [Срок оценки: Up to 24months]

Вторичные конечные точки (8)

• DOR assessed by the investigator per RECIST v1.1 [Срок оценки: Up to 24months]
• DCR assessed by the investigator per RECIST v1.1 [Срок оценки: Up to 24months]
• TTR assessed by the investigator per RECIST v1.1 [Срок оценки: Up to 24months]
• PFS assessed by investigator per RECIST v1.1 [Срок оценки: Up to 24months]
• OS [Срок оценки: Up to 24months]
• Peak Plasma Concentration (Cmax) [Срок оценки: Up to 24months]
• Trough Plasma Concentration (Cmin) [Срок оценки: Up to 24 months]
• ADA [Срок оценки: Up to 24months]

Критерии участия

Критерии включения

• Voluntarily participate and sign the informed consent form.
• Age ≥ 18 years old, ≤ 75 years old, male or female.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
• Expected survival ≥ 3 months.
• Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and/or radical radiotherapy.
• At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.
• Recently archived or fresh tumor tissue samples are available.
• Have good organ function.
• Have no current birth plans and agree to contraception during the trial.

Критерии исключения

• Presence of any small cell carcinoma component in histopathology.
• Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate/cervical/breast cancer in situ.
• Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.
• During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.
• Adequate washout of previous therapy before the first dose.
• Gastrointestinal abnormalities with obvious clinical manifestations.
• Presence of clinically severe respiratory impairment caused by pulmonary disease complications.
• Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.
• Previous treatment with docetaxel.
• Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.
• Previous history of allogeneic bone marrow or organ transplantation.
• Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.
• Pregnant and/or lactating females.
• Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and/or uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06868732 · JSKN016-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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