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AzTrials

Extensive Stage Small Cell Lung Cancer (ES-SCLC)NCT06853678

Second-line Immunotherapy for ES-SCLC

A study testing Adebrelimab, Selinexor and Nab-paclitaxel in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Adebrelimab, Selinexor and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
28 Feb 2025to 1 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Age ≥ 18 years old, male or female;
  • ECOG PS score 0-1 points;
  • Expected survival period is not less than 12 weeks;
  • Patients with pathologically (histologically or cytologically) confirmed small cell lung cancer (according to the 2015 classification of the World Health Organization);
  • Patients with extensive stage small cell lung cancer confirmed by imaging (staging according to the eighth edition of TNM staging);
  • With measurable lesions (according to RECIST 1.1 standards, the long diameter of the tumor lesion on CT scan is ≥ 10mm);
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  • Need to have failed standard first-line treatment before enrollment;
  • Agree to collect tumor histological specimens required for this study and use them in related research;
  • Main organ function is normal, without severe abnormal blood, heart, lung, liver, kidney function and immunodeficiency diseases.
  • Female subjects of childbearing potential must undergo a serum or urine pregnancy test within 72 hours before starting the trial drug, and the result must be negative, and they must be willing to use a medically approved high-efficiency contraceptive method (such as intrauterine contraceptive device, contraceptive pills or condoms) during the study and within 90 days after the last administration of the trial drug; male subjects whose partners are female subjects of childbearing potential should be surgically sterilized or agree to use effective contraceptive methods during the study and within 90 days after the last administration of the trial drug.
  • Subjects voluntarily join this study and sign the Informed Consent Form (ICF), have good compliance, and can follow up the efficacy and adverse reactions as required by the protocol

Who cannot join

  • Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects who can be controlled only by hormone replacement therapy can be included]; subjects with skin diseases that do not require systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes or asthma that has been completely relieved in childhood and does not require any intervention in adulthood can be included; asthma patients who require bronchodilators for medical intervention are not included);
  • Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, untreated active hepatitis B (HBsAg positive or HBV DNA ≥ 500 IU/ml and abnormal liver function), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method and liver function is abnormal) or co-infection with hepatitis B and hepatitis C;
  • Subjects who need systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent dose of similar hormones) or other immunosuppressants within 14 days before the first use of the trial drug;
  • Subjects who received live attenuated vaccines within 4 weeks before the first dose or planned to receive them during the study;
  • Subjects who have previously or are currently using any other anti-tumor treatment for SCLC;
  • Subjects who have suffered from malignant tumors other than SCLC in the past 5 years, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
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  • Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment;
  • Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms for men and ≥470ms for women). According to NYHA standards, patients with grade III-IV heart failure, or left ventricular ejection fraction (LVEF) <50% indicated by cardiac ultrasound examination, had the following conditions within 6 months before entering the study: myocardial infarction, severe/unstable angina, NYHA grade 2 or above heart failure, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
  • Urinalysis indicated urine protein ≥ (++), or 24-hour urine protein ≥ 1.0 g;
  • Patients with thrombotic diseases requiring long-term anticoagulation therapy with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day);
  • Systemic antibiotics used for ≥7 days within 4 weeks before the first dose, or unexplained fever >38.5℃ during the screening period/before the first dose (fever caused by tumors can be included in the study as determined by the investigator);
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Pregnant or lactating women; patients of fertile potential who are unwilling or unable to take effective contraceptive measures;
  • Known allergic reactions, hypersensitivity reactions, or intolerance to carrelizumab and other monoclonal antibodies, pemetrexed, albumin-paclitaxel, prophylactic medications, or their excipients;
  • Any condition that the investigator believes may harm the subject or cause the subject to be unable to meet or perform the study requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yanwei Li, Professor contact

13920292059

liyanwei127@hotmail.com

China1 site, 1 recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality

    Yanwei Li, Professor, 13920292059, liyanwei127@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Selinexor Combined With Nab-paclitaxel and Adebrelimab as Second-line Treatment for ES-SCLC：A Prospective, Single-center, Single-arm Clinical Study

At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine, paclitaxel or vinorelbine, etc., but due to limited benefits to patients, patients are also recommended to participate in relevant clinical studies. New treatment methods are constantly being explored in second-line treatment, including fluzoparib combined with adebelimumab. The current status of second-line treatment is still worrying.

Selinexor is a class of nuclear export selective inhibitors (SINEs) for the export protein receptor XPO1. PO1 promotes the transport of mRNA and cargo proteins, including tumor suppressor proteins (TSPs), hormone receptors (GRs), and immune response regulators. Selinexor covalently binds to the XPO1 protein, blocking the export of TSPs and GRs and accumulating them in the nucleus, preventing the translation of oncoprotein mRNA, stopping the cell cycle process, and initiating apoptosis. Multiple in vitro and in vivo studies have verified that selinexor combined with chemotherapy/radiotherapy/targeted therapy exhibits significant anti-tumor activity.

This study plans to use selinexor combined with adebrelimab and albumin-paclitaxel as a second-line treatment for ES-SCLC to explore the efficacy and safety of this regimen.

Being tested
Adebrelimab, Selinexor, Nab-paclitaxel

What participants receive

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

  • AdebrelimabDrug

    1200mg,d1,iv,q3w

  • SelinexorDrug

    40mg,twice weekly,d1, d3,oral,q3w

  • Nab-paclitaxelDrug

    100mg/m2,d1,d8,d15,iv,q3w

Study groups in NCT06853678
Study groupRoleWhat they receive
Arm 1ExperimentalImmunotherapy combined with chemotherapy
Receives: Drug: Adebrelimab; Drug: Selinexor; Drug: Nab-paclitaxel

What is being measured

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

  1. Progression-free survival，PFS

    From randomization to tumor progression (of any kind) or death (from any cause).

    Measured: 24months

Secondary outcomes (3)

  1. Objective response rate，ORR

    The proportion of patients whose tumor volume has decreased to a predetermined value and was defined as the percentage of patients with CR and PR.

    Measured: 24months

  2. Disease control rate, DCR

    DCR was defined based on the cumulative objective response and stabilization rates (CR+PR+SD).

    Measured: 24months

  3. Overall survival，OS

    Time from randomization to death from any cause.

    Measured: 24months

Timeline

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

  1. First posted3 Mar 2025
  2. Study start28 Feb 2025 (estimated)
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Mar 2027 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06853678
Sponsor's protocol ID
ES-SCLC-001
Status last verified
Feb 2025
First submitted
25 Feb 2025
Last updated
3 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Adebrelimab, Selinexor and Nab-paclitaxel in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Tianjin Medical University Cancer Institute and Hospital 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 11 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 3 Mar 2025. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Yanwei Li, Professor (13920292059, liyanwei127@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival，PFS (time frame: 24months). 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 NCT06853678.

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 3 Mar 2025.

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