Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT07016126

Recruiting

D-BACE in Combination With Chemotherapy and Carelizumab for Resectable II-IIIA or Potentially Resectable T3-4N2 Stage IIIB NSCLC

Interventional

Phase 3

Guangdong provincial people's hospital

Sponsor: Guangdong Provincial People's Hospital

Last Updated: June 11, 2025
Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.

This study is a single-arm prospective single-center phase II study. Subjects are untreated resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. 70 subjects will be enrolled in this prospective observation aimed at evaluating the clinical efficacy and safety of D-BACE in combination with neoadjuvant chemotherapy and carelizumab in patients with resectable II-IIIIA or potentially resectable T3-4N2 stage IIIB NSCLC. The treatment group regimen will be 3 cycles of D-BACE (DCB-loaded microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and carelizumab (the specific regimen of chemotherapy will be determined by the investigator, and platinum-containing two-agent chemotherapy will generally be used). Adverse events will be monitored throughout the trial and graded for severity according to NCI CTCAE version 5.0. Tissue and blood specimens will be dynamically collected during the course of treatment for translational research.

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Treatment Category

Checkpoint Inhibitors, Chemotherapy

Required Mutations

RAF, HER2, MET, NTRK, RET, BRAF, ALK, ROS1

Trial Started

December 22, 2024

Last Updated by Sponsor

June 11, 2025

Estimated Completion

December 22, 2027

Contact Study

Name:Wei Cui, Dr

Email:cuiwei@gdph.org.cn

Phone:86 15626430801

Eligibility

Inclusion Criteria

Only patients who met all the following criteria were eligible for inclusion in the study:

Provide written informed consent Male or female, aged 18-75 years Eastern Cooperative Oncology Group performance status ≤1 Measurable lesions in accordance with RECIST, version 1.1 Subjects must be able to provide a specimen containing tumor tissue or have a biopsy sample of newly resected tumor tissue available PD-L1 IHC testing was performed at a central laboratory during the screening phase

1. Before treatment, formalin-fixed, paraffin-embedded (FFPE) tissue blocks or non-stained tumor tissue sections and relevant pathology reports must be submitted for biomarker assessment. Tumor-tissue specimens could be fresh or archived within 6 months before enrollment.

2. The tissue must be core needle biopsy section, excisional biopsy section or open biopsy section;

3. It is recommended that fresh paraffin sections (PD-L1 assays be performed within 7 days of sectioning) slides be stored and transported in the dark

4. It is recommended that fresh tissue be fixed in 10% neutral buffered formalin for 24 to 48 hours The patient's lung function or other organ function was evaluated by the surgeon to tolerate local surgical treatment.

Adequate organ function assessment and laboratory screening should be performed within 7 days of initiation of therapy

Reproductive status:

1. A negative pregnancy test (serum or urine) in a woman of childbearing age within 72 hours before the start of treatment

2. women were non-lactating

3. For female patients, appropriate contraception should be used during treatment and for 6 months after the last dose of treatment (i.e., the time required for the 30-day ovulation cycle + the 5 half-lives of the drug).

4. Male subjects must agree to use appropriate contraception during treatment and for 7 months after the last dose of treatment (i.e., the duration of 90-day sperm turnover + 5 half-lives of the drug).

And male subjects had to be willing to avoid donating sperm during this period.

Exclusion Criteria

Medical conditions Stage I, IIIB/IIIC (N3), and stage IV NSCLC patients with previous ICIs immunotherapy, targeted therapy, chemotherapy, and other systemic antitumor therapies were excluded.

Patients with allergy to contrast media were not eligible. Patients were excluded if their tumors had targeted alterations in EGFR and/or ALK or were known to have targeted alterations in ROS1, BRAF, HER-2, NTRK, MET, or RET. K-RAS mutations could be enrolled.

Active known or suspected autoimmune disease Participants were eligible if they had type I diabetes, hypothyroidism requiring only hormone-replacement therapy, skin conditions (e.g., vitiligo, psoriasis, or alopecia) that did not require systemic treatment, or other conditions that were not expected to recist in the absence of an external trigger.

Patients with active hepatitis B (positive hepatitis B surface antigen HBsAg test) or hepatitis C (positive HCV RNA test) Patients with previous HBV infection or a decommissioned HBV infection (defined as positive for the hepatitis B core antibody HBcAb and negative for HBsAg) were eligible to participate. Patients were required to provide HBV DNA test results before enrollment, and participants who were HBV carriers or required antiviral therapy were not eligible. Patients who tested positive for HCV antibodies could participate in the study only if they had negative PCR results for HCV RNA.

Any history of arterial thrombosis within 6 months of human immunodeficiency virus (HIV) -positive or acquired immunodeficiency syndrome (AIDS), History of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism within 3 months uncontrolled angina, arrhythmia, or congestive heart failure within 5 years other active malignancy (except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer, superficial bladder cancer, or prostate cancer, breast cancer in situ) Patients with contraindications to local treatment (including surgery or intervention) as judged by the investigator.

Serious or uncontrolled medical illness The patient has psychosis or other medical conditions that result in treatment nonadherence History of severe hypersensitivity reactions to other monoclonal antibodies Patients who are unwilling to sign informed consent forms Patients who do not want follow-up Physical and laboratory tests Laboratory screening values must exclude the following criteria (CTCAE version 5 applies)

1. Bone marrow function:

White blood cell count < 2000/uL, neutrophil < 1500/uL, platelet < 100×103/Ul, hemoglobin < 9.0g/dL

2. Liver function:

1. Serum total bilirubin > 1.5 times the upper limit of normal value (ULN);

2. In the case of liver metastases, AST and ALT were > 5×ULN and total bilirubin > 1.5ULN

3. Coagulation function:

Abnormal coagulation function was defined as international normalized ratio (INR) or prothrombin time (PT) > 1.5 times ULN; If the subject was receiving anticoagulant therapy, PT was outside the intended use of anticoagulant drugs.

4. Renal function:

Urinary protein > 2+, or 24-hour urinary protein ≥1g; Serum creatinine > 1.5×ULN or calculated creatinine clearance (CrCl) < 50ml/min (using Cockcroft-Gault formula) Female CrCL=([140-age] × weight (kg) ×0.85)/(72× serum creatinine (mg/dL) Male CrCL=([140-age] × weight (kg) ×1.00)/(72× serum creatinine (mg/dL) Allergy and adverse drug reactions 1) A history of hypersensitivity to other monoclonal antibodies 2) A history of allergic or hypersensitive reactions to the components of the study drug Other exclusion criteria

1. Prisoners or subjects under compulsory confinement.

2. subjects who have been involuntarily detained for treatment of mental or physical illness (e.g., infectious disease).

Careful consideration has been given to the eligibility criteria for this study to ensure the safety of the study subjects and to ensure the availability of the study results.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll70

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: 3 cycles of D-BACE (DCB-loaded microspheres loaded with epirubicin 50 mg) in combination with chemotherapy and karelizumab (the specific regimen of chemotherapy is determined by the investigator, and platinum-containing two-agent chemotherapy is generally used).

Interventions:

D-BACE in combination with chemotherapy and karelizumab

Outcome Measures

Primary Outcome Measures

Evaluation of the pCR of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumabFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Evaluation of the pathological complete response (pCR) of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab

Secondary Outcome Measures

Evaluation of the MPR of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumabFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Evaluation of the major pathological response (MPR) of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab

Evaluation of the ORR of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumabFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Evaluation of the ORR of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab

Evaluation of the EFS of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumabFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Evaluation of the EFS of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab

Evaluation of the PFS of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumabFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Evaluation of the PFS of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab

Evaluation of the OS of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumabFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Evaluation of the OS of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab

Evaluation as assessed by CTCAE v4.0 of the safety and tolerability of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumabFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Evaluation as assessed by CTCAE v4.0 of the safety and tolerability of resectable II-IIIA or potentially resectable T3-4N2 stage IIIB NSCLC treated with D-BACE in combination with chemotherapy and karelizumab. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Biomarkers (T-cell subsets) for predicting the efficacy (PFS and OS) of new D-BACE combined with chemotherapy and camrelizumab treatment and subsequent recurrence monitoring were exploredFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

Combined with the results of dynamic multi-omics exploratory analysis of individual patients, biomarkers (T-cell subsets) for predicting the efficacy of new D-BACE combined with chemotherapy and camrelizumab treatment and subsequent recurrence monitoring were explored.

The correlation of imaging response and pathological response with overall PFS and OS was observed and evaluated.From enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

The correlation of imaging response and pathological response with overall PFS and OS was observed and evaluated.

Changes in the infiltrating immune microenvironmentFrom enrollment to the end of treatment at 3 cycle (1 cycle is 21 day)

The changes in the infiltrating immune microenvironment will be evaluated using flow cytometry and immunohistochemistry. Flow cytometry will be performed on peripheral blood samples to quantify the levels of various immune cell populations such as T cells, B cells, natural killer (NK) cells, and dendritic cells. Immunohistochemistry will be conducted on tissue samples to examine the spatial distribution and density of immune cells within the tumor microenvironment, including the expression of immune checkpoint proteins like programmed death-ligand 1 (PD-L1).

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Trial Sites

This study has 1 trial site

Guangdong provincial people's hospital

Guangzhou, Guangdong, CN

Name:Wei Cui, MD

Recruiting

Guangzhou, Guangdong, 518000 CN

Guangdong provincial people's hospital

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