A Study Evaluating BAT3306 Compared With Keytruda® in NSCLC Cancer Participants

Официальное название

A Phase 1, Randomized, Double-blind Study to Compare the Pharmacokinetics, Between BAT3306 and Keytruda® (Pembrolizumab) in Participants With Stage IB-IIIA Non-small Cell Lung Cancer Following Complete Resection

Обзор

Comparing the PK similarity of BAT3306 and Keytruda; in NSCLC participants who were completely removed by surgery as an auxiliary treatment

Подробное описание

This is a multicenter, randomized, double-blind, parallel-controlled, Phase 1 clinical study to evaluate the PK similarity of BAT3306 versus Keytruda® as adjuvant therapy in participants with early stage NSCLC. Participants must have no EGFR gene mutation or ALK gene rearrangement, have not received neoadjuvant or adjuvant radiotherapy and/or neoadjuvant chemotherapy, and have no plans for such treatment. A total of approximately 160 eligible participants will be randomly assigned in a 1:1 ratio to 2 double-blind treatment groups.

Participants who meet all inclusion criteria and none of exclusion criteria will be randomized in an Interactive Web Response System (IWRS).

All participants will receive the investigational medicinal product at 200 mg via intravenous infusion every 3 weeks for a treatment period of up to 12 months . Serum samples will be collected from participants at specified time points for PK analysis to evaluate the PK similarity and PK characteristics of BAT3306 versus Keytruda®, while also assessing their immunogenicity and safety, and preliminarily comparing their improvement in disease-free survival (DFS).

Вмешательства

• Препарат BAT3306
  One vial of 4 mL of concentrate contains 100 mg of BAT3306
• Препарат US-Keytruda®
  One vial of 4 mL of concentrate contains 100 mg of pembrolizumab

Первичные конечные точки

• PK equivalence [Срок оценки: Cycle 1 day 1, day 2, day 3, day 5, day 8, day 15, day 22(each cycle is 21 days)]

Вторичные конечные точки (7)

• PK equivalence [Срок оценки: Cycle 1，2，3，4，5，6，8，12，18（each cycle is 21 days）]
• immunogenicity equivalence [Срок оценки: Weeks 1, 4, 10, 16, 22，34，52]
• Vital signs [Срок оценки: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
• Physical examination [Срок оценки: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
• Laboratory Examination [Срок оценки: The third and sixth weeks of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
• Adverse event [Срок оценки: The third week of every 4 cycles and EOT（No more than 18 cycles）（each cycle is 21 days)]
• DFS（Disease-free survival） [Срок оценки: Through study completion, No more than of 1 year]

Критерии участия

Критерии включения

• Participants must meet all of the following criteria:

• Male or female, aged ≥18 and ≤75 years on the day of signing the Informed Consent Form (ICF);
• Participants are able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures;
• Pathologically confirmed non-small cell lung cancer (NSCLC) after surgery, with a clear histological type and a pathology report provided;

Критерии исключения

• Participants who meet any of the following criteria will be excluded from the study:

• Presence of EGFR gene mutation;
• Pathological diagnosis of small cell lung cancer or mixed tumors with small cell components, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors;
• Have previously received any of the following treatments:

Have received > 4 cycles of adjuvant chemotherapy. Prior neoadjuvant therapy. Major surgery within 4 weeks prior to randomization (including surgery for the primary neoplasm, but excluding vascular access procedures), or expected to undergo major surgery during the study.

Use of Chinese herbal medicine with anti-tumor indications within 14 days prior to randomization.

Use of growth factor support therapy or have received a transfusion within 14 days prior to randomization.

• Prior anti-tumor treatment with anti-PD-1, anti-PD-L1/2, anti-CD137, CTLA-4 modulators, or any other immunomodulatory agents.
• Severe acute or chronic infection, including any active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Union Hospital Tongji Medical College Huazhong University of Science & Technology — Ухань

Идентификаторы

NCT: NCT07180862 · BAT-3306-003-CR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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