AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC)Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment

Официальное название

A Single Arm, Multi-center, Phase II Study of AK112 in Non-squamous Non-small Cell Lung Cancer (NSCLC) Patients With Actionable Genomic Alterations (AGA) Who Have Failed to Previous Tyrosine Kinase Inhibitor (TKI) Treatment

Обзор

AK112 in non-squamous non-small cell lung cancer patients with actionable genomic alterations (AGA) who have failed to previous tyrosine kinase inhibitor (TKI) treatment

Вмешательства

• Препарат AK112
  AK112 Monotherapy

Первичные конечные точки

• Overall response (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [Срок оценки: up to 2 years]

Вторичные конечные точки (9)

• Overall survival (OS) [Срок оценки: up to 2 years]
• Progression-free survival (PFS) [Срок оценки: up to 2 years]
• Duration of response (DoR) [Срок оценки: up to 2 years]
• Disease control rate (DCR) [Срок оценки: up to 2 years]
• Time to response (TTR) [Срок оценки: up to 2 years]
• Percentage of participants with adverse event (AE) [Срок оценки: From the subject signs the Informed Consent Form to 30 days (AE) and 90 days (Serious AE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first,up to 2 years]
• Observed concentrations of AK112 [Срок оценки: From date of enrollment until the end of treatment, assessed up to 2 years]
• Number of participants who develop detectable anti-drug antibodies (ADAs) [Срок оценки: From first dose of AK112 through 90 days after last dose of AK112,up to 2 years]
• Number of participants with programmed cell death ligand 1 (PD-L1) expression positive who achieve CR/PR [Срок оценки: From date of enrollment until the end of treatment, assessed up to 2 years]

Критерии участия

Критерии включения

• Signed the Informed Consent Form (ICF) voluntarily。
• Participants must be aged between 18 and 75 years (inclusive), regardless of gender.
• ECOG performance status of 0 or 1.
• With a life expectancy of ≥3 months.
• Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC.
• Prior to enrollment, participants must have at least one actionable genomic alteration (AGA) confirmed by tumor histology, cytology, or blood-based testing, including: EGFR, ALK, ROS1, NTRK, RET, BRAF and MET. Participants must provide a prior AGA test report; otherwise, AGA testing must be performed at the study site or at a site-designated laboratory before enrollment.
• Previous treatment failure with an AGA-targeted TKI.
• At least one measurable extracranial lesion as defined by RECIST v1.1.
• Adequate organ function confirmed.

Критерии исключения

• Histological or cytological pathology confirming the presence of a small-cell carcinoma component or a predominant squamous cell carcinoma component.
• AGA test report showing the presence of a common EGFR sensitizing mutation.
• Prior receipt of immunotherapy.
• Prior receipt of any systemic anti-tumor therapy for advanced-stage (IIIB-IV) NSCLC other than AGA-targeted TKIs.
• Concurrent participation in another clinical study, unless it is a non-interventional study or the follow-up phase of an interventional study.
• Receipt of AGA-targeted TKI therapy within 2 weeks prior to the first dose; receipt of non-specific immunomodulatory therapy within 2 weeks prior to the first dose.
• Imaging during the screening period shows tumor encasement of major blood vessels or significant necrosis/cavitation, and the investigator determines that study participation would pose a bleeding risk.
• Imaging during the screening period shows tumor invasion of surrounding vital organs or blood vessels.
• Central nervous system metastases: participants assessed by the investigator as not requiring local treatment may be eligible; leptomeningeal metastases are not eligible.
• History of malignancy other than NSCLC within 3 years prior to the first dose; participants with other malignancies that have been cured by local treatment are allowed.
• Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose.
• History of major medical conditions within 1 year prior to the first dose.

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

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07158840 · AK112-215

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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