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

Phase 2

Not yet recruiting

• Conditions: Advanced Solid Tumour
• Interventions: Drug: LBL-024 for Injection; Drug: Docetaxel Injection; Drug: Pemetrexed Disodium for Injection; Drug: Bevacizumab Injection; Drug: Paclitaxel Injection; Drug: Carboplatin Injection

• Registration Number: NCT06783647
• Lead Sponsor: Nanjing Leads Biolabs Co.,Ltd

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Study Start: 2025-05-15
• Primary Completion: 2026-12-24
• Study Completion: 2026-12-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel	Docetaxel Injection	Cohort 1：LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel. LBL-024 dose A,Docetaxel dose B,Bevacizumab dose A. Intravenous infusion on Day 1 of each cycle, Q3W.
LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel	Bevacizumab Injection	Cohort 1：LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel. LBL-024 dose A,Docetaxel dose B,Bevacizumab dose A. Intravenous infusion on Day 1 of each cycle, Q3W.
LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin	Pemetrexed Disodium for Injection	Cohort 2：LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin. LBL-024 dose A,Pemetrexed Disodium dose C,Carboplatin dose D,Paclitaxel dose E. Intravenous infusion on Day 1 of each cycle, Q3W.
LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin	Paclitaxel Injection	Cohort 2：LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin. LBL-024 dose A,Pemetrexed Disodium dose C,Carboplatin dose D,Paclitaxel dose E. Intravenous infusion on Day 1 of each cycle, Q3W.
LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin	Carboplatin Injection	Cohort 2：LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin. LBL-024 dose A,Pemetrexed Disodium dose C,Carboplatin dose D,Paclitaxel dose E. Intravenous infusion on Day 1 of each cycle, Q3W.
LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel	LBL-024 for Injection	Cohort 1：LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel. LBL-024 dose A,Docetaxel dose B,Bevacizumab dose A. Intravenous infusion on Day 1 of each cycle, Q3W.
LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin	LBL-024 for Injection	Cohort 2：LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+Paclitaxel+Carboplatin. LBL-024 dose A,Pemetrexed Disodium dose C,Carboplatin dose D,Paclitaxel dose E. Intravenous infusion on Day 1 of each cycle, Q3W.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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)	Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate(DCR）	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)	Percentage of participants achieving CR and PR and stable disease (SD).
Duration of Response(DOR）	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)	The period from the participants first achieving CR or PR to disease progression.
Cmax	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)	Maximum serum concentration
Tmax	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)	After taking a single dose, Time to reach maximum plasma concentration
immunogenicity	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)	The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.

Trial Locations

Locations (3)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Xiangyang Central Hospital; 🇨🇳 Xiangyang, Hubei, China

Mianyang Central Hospital; 🇨🇳 Mianyang, Sichuan, China