Clinical trial NCT06783647: 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)]
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Solid Tumour
Lead sponsor: Nanjing Leads Biolabs Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Sun Yat-sen University
name: Mianyang Central Hospital
name: Xiangyang Central Hospital
First posted: 2025-01-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 two cohorts.

Cohort 1：Non-squamous NSCLC with progression after receiving PD- (L) 1 combined with platinum-based chemotherapy.

This cohort will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 in combination with bevacizumab and docetaxel. 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 sponsor and investigator assess the safety and tolerability of the combination drugs to be good, the trial 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 2: Patients with locally advanced or metastatic NSCLC who have not received prior systemic therapy and are PD-L1 negative (TPS \< 1%).

This cohort was divided into Group A and Group B. Group A will enroll patients with non-squamous NSCLC.Group B will enroll patients with squamous NSCLC.

This study will enroll up to 210 subjects.

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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Secondary outcomes:
measure: Disease Control Rate(DCR）
timeFrame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
measure: Duration of Response(DOR）
timeFrame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
measure: Cmax
timeFrame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
measure: Tmax
timeFrame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
measure: immunogenicity
timeFrame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Xiangyang
country: China
facility: Xiangyang Central Hospital
state: Hubei
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
Study officials:
affiliation: Sun Yat-sen University
name: li Zhang
role: PRINCIPAL_INVESTIGATOR
References: