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

Launched by NANJING LEADS BIOLABS CO.,LTD · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination drug called LBL-024, which is being tested to see how well it works and how safe it is for patients with advanced solid tumors, particularly non-small cell lung cancer (NSCLC). The trial is open to adults aged 18 to 75 who are willing to follow the treatment plan and attend scheduled visits. To participate, patients need to have a certain level of health, as measured by a performance score, and must have at least one measurable tumor. It’s important that women of childbearing age are not pregnant and use effective birth control during the trial.

Participants can expect to receive the study drug along with other treatments and will be monitored closely for any side effects or changes in their condition. They will also need to undergo regular lab tests to ensure their organs are functioning well. This trial is not yet recruiting participants, so there’s still time to learn more and decide if it's the right option for you or a loved one. If you have any questions about eligibility or what to expect, discussing it with your healthcare provider is a great first step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• • 4. The expected survival time is at least 12 weeks.
• • 5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion.
• • 6. There is adequate organ and bone marrow function,Conforms to laboratory test results.
• • 7. 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:
• • 1. Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
• • 2. Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
• • 3. Patients with active infection and currently requiring intravenous anti-infective therapy.
• • 4. Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
• • 5. The patient has a Medical history of immunodeficiency, including HIV antibody positive.
• • 6. Active hepatitis B or active hepatitis C.
• • 7. Women during pregnancy or lactation.
• • 8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.