A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)

Официальное название

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-Drug Conjugate (ADC), Compared to Investigator's Choice Therapy in Participants With Relapsed Small Cell Lung Cancer

Обзор

The purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.

Вмешательства

• Препарат ZL-1310
  ZL-1310 as a single-agent
• Препарат Investigator's Choice of Therapy
  Topotecan, Lurbinectedin, or Amrubicin

Первичные конечные точки

• Confirmed objective response rate (ORR) assessed by Blinded Independent Central Review of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]
• Overall survival of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]

Вторичные конечные точки (9)

• Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]
• Progression-free survival (PFS) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]
• Confirmed ORR assessed by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]
• Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]
• Confirmed CNS response assessed by BICR per Response Assessment in Neuro-Oncology for Brain Metastases (RANO-BM) of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]
• Occurrence of treatment-emergent adverse events (TEAEs) of ZL-1310 compared to Investigator's Choice Therapy (ICT) [Срок оценки: up to 27 months]
• Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EQ-5D-5L [Срок оценки: up to 27 months]
• Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-C30 [Срок оценки: up to 27 months]
• Changes from baseline in quality of life related parameters of ZL-1310 compared to Investigator's Choice Therapy (ICT) using EORTC-QLQ-LC13 [Срок оценки: up to 27 months]

Критерии участия

Критерии включения

• Age >/= 18 years, or considered an adult by local regulations, at the time of consent
• Signed informed consent
• Histologically or cytologically confirmed SCLC. Received 1L platinum-based systemic therapy and had documented disease progression during or after the most recent systemic therapy. Or received 2L tarlatamab is allowed.
• Measurable disease according to RECIST v1.1 as assessed by the investigator.
• Participants with a history of treated and stable or untreated and asymptomatic CNS metastases based on criteria per protocol.
• Adequate organ and marrow function
• Eastern Cooperative Group (ECOG) performance status of 0 or 1
• Life expectancy of at least 3 months
• Participants must be willing to undergo a tumor biopsy or provide archived tumor tissue sample at Screening
• Participants must be willing and able to comply with protocol for the duration of the study

Критерии исключения

• Received more than one line of systemic therapy for Extensive-Stage SCLC.
• Received any prior ADC with topoisomerase 1 inhibitor payload
• Participants with another known malignancy with exceptions defined in the protocol.
• History or suspected ILD/pneumonitis based on criteria per protocol
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
• Receipt of anti-cancer treatment known to treat cancers within 3 weeks before the first dose of study treatment.
• Prior radiotherapy before study treatment based on criteria per protocol
• Unresolved toxicity of Grade >/= 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
• Known infection or active infection defined in the protocol.
• Clinically significant active cardiovascular disease or history of arterial thromboembolic event within 6 months prior to the first dose of study treatment based on criteria per protocol.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 31 центр

• Zai Lab Site 02050 — La Jolla
• Zai Lab Site 02033 — Sacramento
• Zai Lab Site 02037 — Aurora
• Zai Lab Site 02030 — New Haven
• Zai Lab Site 02045 — Clermont
• Zai Lab Site 02031 — Orange City
• Zai Lab Site 02020 — Rockledge
• Zai Lab Site 02026 — Sarasota
• … и ещё 23 центра

Китай · 18 центров

• Zai Lab Site 01002 — Хэфэй
• Zai Lab Site 01014 — Xiamen
• Zai Lab Site 01001 — Гуанчжоу
• Zai Lab Site 01011 — Naning
• Zai Lab Site 01022 — Heilongjiang
• Zai Lab Site 01008 — Shijiazhuang
• Zai Lab Site 01010 — Чжэнчжоу
• Zai Lab Site 01034 — Ухань
• … и ещё 10 центров

Япония · 16 центров

• Zai Lab Site 10018 — Fukuoka
• Zai Lab Site 10017 — Fukuoka
• Zai Lab Site 10019 — Kurume
• Zai Lab Site 10016 — Hiroshima
• Zai Lab Site 10009 — Yokohama
• Zai Lab Site 10015 — Kashihara
• Zai Lab Site 10011 — Hirakata
• Zai Lab Site 10014 — Izumi
• … и ещё 8 центров

Turkey (Türkiye) · 4 центра

• Zai Lab Site 14013 — Adana
• Zai Lab Site 14014 — Ankara
• Zai Lab Site 14012 — Istanbul
• Zai Lab Site 14003 — Istanbul

Великобритания · 4 центра

• Zai Lab Site 21003 — London
• Zai Lab Site 21011 — Chelsea
• Zai Lab Site 21012 — Sutton
• Zai Lab Site 21001 — Stoke-on-Trent

Австрия · 1 центр

• Zai Lab Site 22002 — Salzburg

Нидерланды · 1 центр

• Zai Lab Site 20004 — Hilversum

Испания · 1 центр

• Zai Lab Site 08032 — Valencia

Идентификаторы

NCT: NCT07218146 · ZL-1310-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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