Study of ZKAB001 Combined With Carboplatin and Etoposide in the Extensive Small Cell Lung Cancer

NCT04346914 | Unknown Phase 1

• 1 other identifier: NTL-LEES-2019-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of recombinant anti-PD-L1 monoclonal antibody injection (ZKAB001) combined with carboplatin and etoposide in the treatment of extensive-stage small cell lung cancer.

Conditions

Extensive Stage Small Cell Lung Cancer

Keywords

ES-SCLC

Outcome Measures

Primary Outcomes (1)

• DLT

  The number of patients who permanently stop taking drugs due to toxicity is less than 1/3 of the total number of patients.

  28 days after first dose

Secondary Outcomes (5)

• objective response rate

  12 months

• progression free survival

  12 months

• The positive rate of PD-L1 expression in tumor tissue

  12 months

• The positive rate of anti-drug antibody (ADA);

  12 months

• overall survival

  12 months

Study Arms (1)

Combined treatment group

EXPERIMENTAL

recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide ZKAB001 ,5 mg/kg, d1，q3w； carboplatin，5 AUC，d1，q3w； etoposide，100mg/m2，d1\~3，q3w

Biological: recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide

Interventions

recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide BIOLOGICAL

ZKAB001 ,5 mg/kg, d1，q3w； carboplatin，5 AUC，d1，q3w； etoposide，100mg/m2，d1\~3，q3w

Combined treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• both men and women, age ≥ 18 years old and ≤ 75 years old.
• histologically confirmed SCLC
• extensive stage SCLC (ES-SCLC) according to (VALG) staging of American Veterans Lung Cancer Association.
• have not received first-line systemic therapy for ES-SCLC in the past.
• surgery and adjuvant therapy for cure, such as radiotherapy and chemotherapy, were performed in the past, and there was no treatment interval of at least 6 months from the last chemotherapy, radiotherapy or radiotherapy or chemotherapy to the diagnosis of ES-SCLC.
• PS 0 or 1.
• estimated survival time \> 12 weeks.
• CT or MRI scan with at least one measurable lesion less than 28 days before the first dose of the study drug (RECIST v1.1).
• male subjects and women of childbearing age must have contraception within 6 months from the beginning of the first drug study to the last study drug.
• before the first dose of the drug, the laboratory test values met the following conditions: (1) Blood routine test: WBC ≥ 3.0x10\^9 / L, ANC ≥ 1.5x10\^9 /L, PLT ≥ 100x10\^9 /L, hGB ≥ 90g / L; (2) liver function: AST ≤ 2.5 ULN, ALT ≤ 2.5 ULN; ALT and AST \< 5 ULN for liver metastases; TBIL ≤ 1.5 ULN; ALB ≥ 30 g L; (3) Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance rate (Ccr) ≥ 40 mL/min (Cockcroft/Gault formula); (4) Coagulation function: INR ≤ 1.5, APTT ≤ 1.5 ULN; (5) ALP ≤ 2.5 ULN, ALP ≤ 5 ULN. for bone metastasis subjects,
• tumor tissue samples that can meet the detection of PD-L1 expression can be provided during the screening period and within 4 weeks after selection.
• voluntarily sign informed consent form (ICF)

You may not qualify if:

• before entering the group, the patients received any T cell co-stimulatory or immune checkpoint inhibitors, including, but not limited to, cytotoxic T lymphocyte associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors or other drugs targeting T cells; previously received anti-vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR) therapy.
• active brain metastasis or meningeal metastasis.
• Patients with brain metastasis after treatment need to meet the following conditions: asymptomatic; no imaging evidence of progress ≥ 4 weeks after treatment; completion of treatment within 14 days before the first dose of the study drug; and no need to receive systemic corticosteroids (\> 10mg/ prednisone or equivalent) less than 14 days before the first dose of the study drug.
• radiotherapy for the chest and whole brain was completed less than 4 weeks before the first dose of the study drug (palliative radiotherapy for bone lesions is allowed ).
• the third space effusion with clinical symptoms, such as pericardial effusion, pleural effusion and peritoneal effusion which cannot be controlled by pumping or other treatment.
• active, known or suspected autoimmune diseases. Patients with vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis that only require hormone replacement therapy, or are not expected to recur in the absence of external stimulation can be included in the group.
• corticosteroids (\> 10 mg/ prednisone or equivalent dose) or other immunosuppressants were used within 14 days before the first study.
• Inhalation or topical use of steroids and adrenal replacement steroids are allowed in the absence of active autoimmune disease; for patients receiving short-term, systemic immunosuppressive therapy, for example, glucocorticoids for nausea, vomiting, or allergic reaction management or preventive use can be admitted after consultation with the sponsor. Allow the use of salt corticosteroids in the treatment of postural hypotension and the use of low-dose glucocorticoid supplements in the treatment of adrenocortical insufficiency;
• subjects who had been vaccinated or planned to receive live vaccines within 4 weeks before the first study.
• Interstitial pneumonia (ILD) disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms.
• active pulmonary tuberculosis or screening subjects with a history of active pulmonary tuberculosis infection within 1 year before treatment, whether treated or not.
• except for alopecia and fatigue, other toxicities caused by previous antineoplastic therapy need to be restored to CTCAE 5.0 ≤ 1 before the first dose. Some other toxicities caused by previous antineoplastic therapy are not expected to be resolved and have long-term persistent sequelae, such as neurotoxicity caused by platinum-based therapy, which are allowed to be included in the group.
• uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90 mmHg), history of hypertensive crisis or hypertensive encephalopathy.
• there are uncontrolled clinical symptoms or diseases of the heart, such as: (1)heart failure defined by New York Heart Association (NYHA)in grade 2 or above (2) unstable angina pectoris (3) myocardial infarction within 6 months (4) clinically significant supraventricular or ventricular arrhythmias need to be treated.
• uncontrolled active infections (e.g. need intravenous antibiotics, antifungal or antiviral therapy).

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 021, China

RECRUITING

Related Publications (1)

• Lu S, Chen Z, Cui J, Guo R, Li Z, Li BX, Dai X. Efficacy and Safety of Anti-Programmed Death-Ligand 1 Monoclonal Antibody Socazolimab With Carboplatin and Etoposide for Extensive-Stage SCLC: Results From the Phase 1b Clinical Trial. JTO Clin Res Rep. 2023 Feb 28;4(4):100478. doi: 10.1016/j.jtocrr.2023.100478. eCollection 2023 Apr.

  PMID: 37020926 DERIVED

MeSH Terms

Interventions

Carboplatin; Etoposide

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: March 8, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)