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Extensive Stage Small Cell Lung CancerPhase 1NCT04346914

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

A Phase 1 study testing recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide in people with Extensive Stage Small Cell Lung Cancer, run by Lee's Pharmaceutical Limited at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Extensive Stage Small Cell Lung Cancer
What is being tested?
recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
8 Mar 2020to 30 Oct 2022
Phase
Phase 1
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)

Who cannot join

  • 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.
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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;
  • 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).
  • HIV infection, HBsAg positive and peripheral blood HBV-DNA titer ≥ 0.5 × 10^3 copies / mL or HCV positive (HCV RNA or HCV Ab test indicated acute or chronic infection).
  • pregnant or lactating women.
  • known allergies to study drugs or excipients, and known severe allergic reactions to any monoclonal antibody; allergic history of carboplatin or etoposide.
  • other malignant tumors occurred less than 5 years before the first dose, except for fully treatable cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, ductal carcinoma in situ after radical resection, and breast cancer without recurrence and metastasis after radical resection.
  • known cases of mental illness, alcohol abuse, inability to quit smoking, drug use or substance abuse.
  • have been treated with any other experimental drugs or participated in another interventional clinical study within 4 weeks before signing ICF

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 021

    Shun Lu, doctor, +8621-62821990, shun_lu@hotmail.com

    ＋8618017321552, drchenzhiwei@163.com

    Recruiting

Other trials in China

About this study

Official title: Phase Ib Study of Recombinant Anti-PD-L1 Monoclonal Antibody Injection (ZKAB001) Combined With Carboplatin and Etoposide in the Treatment of Extensive Small Cell Lung Cancer

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.

Read the detailed description

To evaluate the safety and preliminary efficacy of recombinant anti-PD-L1（Programmed cell death ligand 1）monoclonal antibody injection (ZKAB001) combined with carboplatin and etoposide in the treatment of extensive-stage small cell lung cancer. The study will last until the number of patients who permanently stop taking drugs due to toxicity in the first two cycles is less than 1/3 of the total number of patients.

Being tested
recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide
Keywords
ES-SCLC

What participants receive

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

  • recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposideBiological

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

Study groups in NCT04346914
Study groupRoleWhat they receive
Combined treatment groupExperimentalrecombinant 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
Receives: Biological: recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide

What is being measured

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

  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.

    Measured: 28 days after first dose

Secondary outcomes (5)

  1. objective response rate

    Percentage of patients in partial and complete response

    Measured: 12 months

  2. progression free survival

    time between first dose of study drug to disease progression

    Measured: 12 months

  3. The positive rate of PD-L1 expression in tumor tissue

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

    Measured: 12 months

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

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

    Measured: 12 months

  5. overall survival

    time between first dose of study drug to death caused by any reason

    Measured: 12 months

Timeline

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

  1. First posted15 Apr 2020
  2. Study start8 Mar 2020
  3. Primary completion30 Oct 2022 (estimated)
  4. Study completion30 Oct 2022 (estimated)

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04346914
Sponsor's protocol ID
NTL-LEES-2019-03
Status last verified
May 2022
First submitted
13 Apr 2020
Last updated
11 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 1 study testing recombinant anti-PD-L1 monoclonal antibody injection combined with 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: status not confirmed, as of the sponsor's last update on 11 May 2022. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: 28 days after first dose). 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 NCT04346914, which also lists 1 linked publication.

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 11 May 2022.

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