A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]

Официальное название

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 01(NSCLC)]

Обзор

An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.

Подробное описание

This trial is an open-label, multicenter, phase II clinical study of LBL-024 combination therapy in patients with advanced NSCLC, to evaluate the efficacy and safety of LBL-024 combination therapy .The trial includes 4 cohorts.

Cohort 1 A:This cohort will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration. Eligible subjects will be randomized in a 1: 1 ratio to Arm A or Arm B.

Cohort 1 B:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs.If the safety and tolerability of combination drugs are good, the Cohort will continue to enroll subjects for the extension study of combination administration.

Cohort 2 A:This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration, and after a period of time, LBL-024 and pemetrexed will be used for maintenance treatment.After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.

Cohort 2 B: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration and after a period of time, and then use LBL-024 for maintenance treatment. After completing the 21-day safety observation, the safety and tolerability of combination drugs will be assessed. If the safety and tolerability of combination drugs are good, this cohort will continue to enroll subjects.

This study will enroll up to 230 subjects.

Вмешательства

• Препарат LBL-024 for Injection
  intravenous infusion.
• Препарат Docetaxel Injection
  intravenous infusion.
• Препарат Bevacizumab Injection
  intravenous infusion.
• Препарат Pemetrexed Disodium for Injection
  intravenous infusion.
• Препарат Paclitaxel Injection
  intravenous infusion.
• Препарат Carboplatin Injection
  intravenous infusion.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Вторичные конечные точки (5)

• Disease Control Rate(DCR） [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Duration of Response(DOR） [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Cmax [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• Tmax [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]
• immunogenicity [Срок оценки: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)]

Критерии участия

Критерии включения

• Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
• Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
• The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
• The expected survival time is at least 12 weeks.
• According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
• There is adequate organ and bone marrow function,Conforms to laboratory test results.
• Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Критерии исключения

• Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
• Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
• Patients with active infection.
• Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
• The patient has a Medical history of immunodeficiency, including HIV antibody positive.
• Active hepatitis B or active hepatitis C.
• Women during pregnancy or lactation.
• History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

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

Китай · 24 центра

• Anhui Provincial Cancer Hospital — Хэфэй
• Beijing Cancer Hospital — Пекин
• Beijing Chest Hospital，Capital Medical University — Пекин
• Fujian Cancer Hospital — Фучжоу
• The First Affiliated Hospital of Xiamen University — Xiamen
• Sun Yat-sen University Cancer Center — Гуанчжоу
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Гуанчжоу
• Affiliated Hospital of Guilin Medical University — Guilin
• … и ещё 16 центров

Идентификаторы

NCT: NCT06783647 · LBL-024-CN004_01(NSCLC)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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