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

Official title

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)]

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: 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)]

Secondary outcome measures (5)

• Disease Control Rate(DCR） [Time frame: 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） [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 24 centers

• Anhui Provincial Cancer Hospital — Hefei
• Beijing Cancer Hospital — Beijing
• Beijing Chest Hospital，Capital Medical University — Beijing
• Fujian Cancer Hospital — Fuzhou
• The First Affiliated Hospital of Xiamen University — Xiamen
• Sun Yat-sen University Cancer Center — Guangzhou
• The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou
• Affiliated Hospital of Guilin Medical University — Guilin
• … and 16 more centers

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗