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Extensive-stage Small-cell Lung CancerPhase 3NCT04878016

A Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With ES-SCLC

A Phase 3 study testing ZKAB001, Carboplatin and Etoposide in people with Extensive-stage Small-cell Lung Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, Phase III, multicenter, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of ZKAB001 in combination with carboplatin + etoposide compared with treatment with placebo + carboplatin + etoposide in patients who have ES-SCLC and are untreated for their… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive-stage Small-cell Lung Cancer
What is being tested?
ZKAB001, Carboplatin and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
498 participants
Where
1 siteChina
Study dates
15 Jul 2021to 13 Oct 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both men and women, age ≥ 18 years.
  • Small Cell Lung Cancer confirmed by histology or cytology.
  • Extensive-stage SCLC (defined as AJCC 8th Edition IV (Tany,Nany,M1a/b/c), or T3-4 cannot be included in a tolerable radiotherapy plan due to multiple pulmonary nodules or tumor/nodule size).
  • Have not received first-line systemic treatment 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.
  • ECOG PS 0,1.
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  • The estimated survival ≥ 8 weeks.
  • CT or MRI scan with at least one measurable lesion (according to RECIST v1.1) ≤ 28 days before administration of the first study drug.
  • Male partners of childbearing age and female subjects of childbearing age must have contraception within 6 months after signing the informed consent form to the last study of the drug, and the (HCG) test of human chorionic gonadotropin in blood / urine of female subjects of childbearing age must be negative 7 days before the first use of the drug.
  • Before the first dose , the laboratory test values meets the following conditions: (1) Blood routine test (corrected without blood transfusion and hematopoietic factor drugs within 14 days before screening): White blood cell count ((WBC) ≥ 3.0x10^9); absolute neutrophil count ((ANC)) ≥ 1.5x10^9; platelet (PLT) ≥ 100x10^9; hemoglobin content ((hGB) ≥ 90g). (2) Liver function: aspartate aminotransferase (AST) ≤ 2.5 ULN, alanine liver aminotransferase (ALT) ≤ 2.5 ULN; ALT and AST < 5 ULN; serum total bilirubin (TBIL) ≤ 1.5 ULN; albumin (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: international standardized ratio (INR) ≤ 1.5 ULN, activated partial thromboplastin time (APTT) ≤ 1.5 ULN; (5) alkaline phosphatase (ALP) ≤ 2.5 ULN, bone metastasis subjects, ALP ≤ 5 ULN.
  • Tumor tissue samples that can meet the the requirements of PD-L1 expression detection can be provided within 4 weeks from the screening period to 4 weeks after enrollment.
  • Sign informed consent form voluntarily，have good compliance and cooperation with follow-up.

Who cannot join

  • Received any T cell costimulatory or immune checkpoint inhibitors before entering the group, 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 7 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. If a new asymptomatic brain metastasis is found during the screening period, radiotherapy and/or surgery are required.
  • If all other criteria are met after treatment, additional brain scans are not required before randomization.
  • The completion time of radiotherapy for the brain and palliative radiotherapy for the focus of bone disease is less than 7 days before the first dose of the study drug.
  • Active, known or suspected autoimmune diseases, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granuloma, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis. Only cases of residual hypothyroidism due to autoimmune thyroiditis, controlled type I diabetes, or no recurrence expected in the absence of external stimulation that require hormone replacement therapy can be included. Only patients with eczema, psoriasis, neurodermatitis or vitiligo (psoriatic arthritis patients will need to be excluded) can be enrolled in the group if they meet the following conditions: the area covered by the rash must be less than 10% of the body surface area; the disease is well controlled at the baseline level, requiring only inefficient topical steroids, and those with no acute exacerbation in the past 12 months can be enrolled.
  • Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage (once a month or more frequently). Patients who use indwelling catheters are allowed to be selected.
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  • 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.
  • Patients who had been vaccinated or planned to receive live vaccines within 4 weeks before drug administration were studied for the first time.
  • Major surgery was performed within 4 weeks before drug administration, or major surgery was planned during the study period.
  • Interstitial pneumonia (ILD) disease, drug-induced pneumonia, radiation pneumonia requiring steroid treatment or active pneumonia with clinical symptoms.
  • Active pulmonary tuberculosis or screening patients with a history of active pulmonary tuberculosis infection within 1 year before treatment, whether treated or not.
  • Uncontrolled cardiovascular diseases, such as: (1) New York Heart Association (NYHA) grade 2 or above heart failure (2) unstable angina pectoris (3) myocardial infarction or cerebrovascular accident 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).
  • Active hepatitis B or C (unless HBV-DNA titer < 500IU/mL or copy number < 1000copies/ml, HCV-RNA negative after antiviral treatment can be included in), HIV positive or known history of acquired immunodeficiency syndrome.
  • Known allergies to research drugs or excipients, and known severe allergic reactions to any monoclonal antibody; allergic history of carboplatin or etoposide.
  • Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation.
  • Other malignant tumors occurred less than 5 years before the first dose, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical mastectomy.
  • Have been treated with any other experimental drugs or participated in another interventional clinical study within 4 weeks before signing ICF.
  • Pregnant or lactating women.
  • Known cases of mental illness, alcohol abuse, inability to quit smoking, drug use or substance abuse.
  • Other situations judged by the investigators to be unsuitable for inclusion in the group

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 021

Other trials in China

About this study

Official title: A Phase III, Randomized，Double-blind Placebo-controlled Study of Carboplatin Plus Etoposide With or Without ZKAB001 (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-stage Small Cell Lung Cancer

This is a randomized, Phase III, multicenter, double-blinded, placebo-controlled study designed to evaluate the safety and efficacy of ZKAB001 in combination with carboplatin + etoposide compared with treatment with placebo + carboplatin + etoposide in patients who have ES-SCLC and are untreated for their extensive-stage disease.

Read the detailed description

This study is a randomized, double-blind, placebo-controlled multicenter III study.

Eligible patients will randomly enter the trial group or control group at 1:1, that is, ZKAB001+ carboplatin + etoposide or placebo + carboplatin + etoposide, with a treatment cycle every 3 weeks. There are 4 cycles of chemotherapy.

Stratification factors included gender (male / female), PS score (0/1) and brain metastasis (yes / no).

The study included screening period, treatment period (subjects received study treatment until confirmed disease progression, or intolerable toxic reaction, or reached the maximum medication cycle of 2 years, or the subject voluntarily requested the end of the study treatment) and follow-up period (including safety follow-up and survival follow-up).

Being tested
ZKAB001, Placebo, Carboplatin, Etoposide
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZKAB001Biological

    Patients will receive ZKAB001 5mg/kg administered by IV infusion every 21days，

  • PlaceboDrug

    Patients will receive placebo administered by IV infusion every 21days.

  • CarboplatinDrug

    Carboplatin should be administered after completion of placebo/ZKAB001 by IV infusion over 30-60 minutes to achieve an initial target AUC of 5 mg/mL/min. Carboplatin and etoposide will be used for a total of 4 cycles， followed by placebo/ZKAB001 maintenance therapy.

  • EtoposideDrug

    Etoposide (100 mg/m^2) should be administered intravenously over 60 minutes following carboplatin administration. On Days 2 and 3 of each cycle, etoposide 100 mg/m2) should be administered intravenously over 60 minutes.

    Carboplatin and etoposide will be used for a total of 4 cycles， followed by placebo/ZKAB001 maintenance therapy.

Study groups in NCT04878016
Study groupRoleWhat they receive
ZKAB001＋carboplatin+etoposideExperimentalThe induction phase will consist of four cycles of ZKAB001 plus chemotherapy, with each cycle being 21 days in duration. On Day 1 of each cycle, patients will receive drug infusions in the following order: ZKAB001 → carboplatin → etoposide
Receives: Biological: ZKAB001; Drug: Carboplatin; Drug: Etoposide
placebo + carboplatin + etoposidePlacebo comparatorThe induction phase will consist of four cycles of placebo plus chemotherapy, with each cycle being 21 days in duration. On Day 1 of each cycle, all eligible patients will receive drug infusions in the following order: placebo → carboplatin → etoposide
Receives: Drug: Placebo; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    The time from the date of randomization to the date of death from any cause.

    Measured: 2 years

Secondary outcomes (7)

  1. progression free survival

    The time between the date of randomization and the date of first documented disease progression or death, whichever occurs first.

    Measured: 2 years

  2. objective response rate

    ORR is defined as either an unconfirmed CR or a PR, as determined by the investigator using RECIST v1.1.

    Measured: 2 years

  3. disease control rate

    It refers to the percentage of patients with the best overall efficacy of CR, PR and SD and maintained for more than 4 weeks in patients who can evaluate the efficacy.

    Measured: 2 years

  4. duration of response

    DOR is defined as the time interval from the date of the first occurrence of a CR or PR (whichever status is recorded first) until the first date that progressive disease or death is documented, whichever occurs first.

    Measured: 2 years

  5. Time to Deterioration

    Time to deterioration will be measured using the EORTC QLQ-C30.

    Measured: 2 years

  6. Time to Deterioration

    Time to deterioration will be measured using the EORTC QLQ-LC13.

    Measured: 2 years

  7. Safety Outcome Measures

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start15 Jul 2021
  3. Primary completion13 Oct 2023
  4. Study completion13 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878016
Sponsor's protocol ID
ZKAB001-LEES-2020-07
Status last verified
Feb 2024
First submitted
29 Apr 2021
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen Z, Chen J, Huang D, Zhang W, Wu L, Yi T, Wang Q, Han L, Tan L, Li Y, Zhang Z, Li N, Li J, Zhang T, Hu Y, Sun H, Wu Y, He Z, Yang R, Cheng P, Li X, Shi J, Yu G, Ma D, Li BX, Dai X, Wong M, Li Y, Yu X, Lu S; Socazolimab Study Group. A multicenter, randomized, double-blind, placebo-controlled phase 3 study of Socazolimab or placebo combined with carboplatin and etoposide in the first-line treatment of extensive-stage small cell lung cancer. Signal Transduct Target Ther. 2025 Jan 13;10(1):28. doi: 10.1038/s41392-024-02115-5.

    PubMed 39800716

  • 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.

    PubMed 37020926

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ZKAB001, Carboplatin and Etoposide in people with Extensive-stage Small-cell Lung Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878016, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.

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