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Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung CancerPhase 2NeoadjuvantNCT06562920

Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer

A Phase 2 study testing adebrelimab and chemotherapy in people with Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung Cancer, run by Zhejiang Cancer 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
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Trial summary

To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
adebrelimab and chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
24 Jul 2024to 31 Jul 2028
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old; Histologically or cytologically confirmed as limited-stage small cell lung cancer (T1-3N0-1M0); All lesions of the patient (including primary lesions, lymph nodes/metastatic lesions assessed as metastases) must be jointly evaluated by surgeons, radiotherapists, and radiologists to be surgically resectable; Subjects must have measurable target lesions (according to RECIST 1.1 standards); ECOG performance status score 0-1; No history of other malignant tumors; No previous anti-tumor treatment such as surgery, radiotherapy, chemotherapy, immunotherapy, etc. related to small cell lung cancer; Patients must have sufficient cardiopulmonary function: FEV1 and DLCO of patients are ≥50% of the predicted value, echocardiography indicates LVEF ≥55%, and no clear signs of heart failure, severe coronary artery stenosis, etc. are found in various tests. Cardiopulmonary function is assessed by surgeons to be able to tolerate surgical treatment;
  • The functional level of each important organ must meet the following requirements:
  • Bone marrow: absolute neutrophil count (ANC) ≥1.5× 109/L, platelets ≥100 × 109/L, hemoglobin ≥9 g/dl;
  • Good coagulation function: defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
  • Liver: total bilirubin ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal;
  • Kidney: serum creatinine ≤1.25 times the upper limit of normal or creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min; Men of childbearing potential and women of childbearing age must agree to take effective contraceptive measures from the signing of the main informed consent until 180 days after the last dose of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test result within ≤ 7 days before the first administration of the study drug; Voluntarily participate in the clinical study; fully understand and be informed of this study and sign the ICF (Informed Consent Form).

Who cannot join

  • All lesions cannot be completely removed by surgery. Received anti-tumor treatment for SCLC (including but not limited to chemotherapy, radiotherapy of the lesion site); Previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors; Any active autoimmune disease or history of autoimmune disease (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis); Patients with complete remission of childhood asthma and no need for any intervention as an adult or vitiligo can be included, but patients who require bronchodilators for medical intervention are not included; Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method) or co-infection with hepatitis B and hepatitis C; Presence of difficult-to-control third-cavity effusion, such as large pleural effusion or ascites or pericardial effusion; Presence of huge mediastinal masses, multiple lesions, extracapsular invasion or fusion of complex small cell lung cancer; Subjects who need systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days before the first medication. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and adrenal hormone replacement therapy with a dose of >10 mg/day of prednisone at an effective dose are allowed; Subjects who have been treated with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before the first medication; Subjects who are participating in other clinical studies or whose first medication time is less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose); Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment, etc.; Combined with severe heart disease Patients with congestive heart failure of grade III or above (NYHA standard), or angina of grade III or above (CCS standard), or a history of myocardial infarction within 6 months before the start of treatment, or arrhythmia requiring drug treatment; Major surgery, open biopsy or significant trauma within 28 days before enrollment; A known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures; Known to have allergic reactions, hypersensitivity reactions or intolerance to study drugs Other conditions that the investigator believes are not suitable for participation in the study.

Trial locations and contacts

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

China1 site, 1 recruiting
  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Jinshi Liu, MD, 86+13958067757, Liujs@zjcc.org.cn

    Jinshi Liu, MD

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Prospective, Exploratory Study of Adebrelimab Combined With Chemotherapy and Concurrent SBRT for Neoadjuvant Treatment of Limited-stage Small Cell Lung Cancer and Analysis of Biological Markers(ASSESS)

To explore the effectiveness and safety of adebrelimab combined with chemotherapy and concurrent SBRT for 3 cycles of neoadjuvant treatment followed by surgery in T1-3N0-1M0 limited-stage SCLC

Read the detailed description

This study plans to enroll 20 patients with resectable limited-stage small cell lung cancer in stage T1-3N0-1M0 who have not been treated before. They will receive 3 cycles of adebelimumab combined with chemotherapy and concurrent SBRT. Surgery will be performed within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion. All patients with tumor recurrence and metastasis will enter survival follow-up. Pathological complete response rate (pCR) and safety indexes were used as the main observation indicators.

Being tested
adebrelimab and chemotherapy
Keywords
small cell lung cancer, Neoadjuvant immunotherapy, SBRT
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.

  • adebrelimab and chemotherapyDrug

    Also called SBRT

    3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment.

Study groups in NCT06562920
Study groupRoleWhat they receive
neoadjuvant anti-PDL-1 Immunotherapy combined chemotherapy and SBRTExperimentalThree cycles of neoadjuvant PDL-1 combined chemotherapy and SBRT followed by surgery for limited-stage small cell lung cancer
Receives: Drug: adebrelimab and chemotherapy

What is being measured

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

  1. pCR

    Pathological Complete Response

    Measured: Assessed average of 1 month after surgery

  2. Safety and Tolerability

    Adverse reactions (according to CTCAE v5 classification)

    Measured: Assessed average of 1 month after surgery

Secondary outcomes (5)
  1. MPR

    Major Pathological response

    Measured: Assessed average of 1 month after surgery

  2. Event-Free Survival(EFS)

    Refers to the time from randomization to the first occurrence of any of the following events: disease progression that is inoperable, local or distant recurrence, death due to any cause, etc.

    Measured: From the time of enrollment, until the disease relapses or metastasizes,assessed up to 5 years follow-up.

  3. Objective Response Rate(ORR)

    The proportion of patients whose tumors shrink to a certain amount and remain shrinking for a certain period of time includes complete remission (CR) and partial remission (PR).

    Measured: From the time of enrollment, assessed before surgery

  4. Overall survival(OS)

    The time from the start of treatment to the death of the subject due to various causes was calculated based on the intention-to-treat population (ITT).

    Measured: From the time of enrollment, assessed up to 5 years follow-up.

  5. Exploration of tumor efficacy markers

    Correlation between MRD biomarkers in tumor tissue and peripheral blood and patients' clinical outcomes, progression, and efficacy.

    Measured: From the time of enrollment, assessed up to 5 years follow-up.

Timeline

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

  1. First posted20 Aug 2024
  2. Study start24 Jul 2024
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2028 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study plans to enroll 20 patients with previously untreated T1-3N0-1M0 resectable limited-stage small cell lung cancer. They will receive 3 cycles of adebrelimab combined with chemotherapy and concurrent SBRT, and undergo surgery within 4-6 weeks after treatment. After surgery, adjuvant therapy will be considered based on the results of MDT discussion.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06562920
Sponsor's protocol ID
IRB-2024-738 (IIT)
Acronym
Neoadjuvant
Status last verified
Aug 2024
First submitted
6 Aug 2024
Last updated
20 Aug 2024
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 Phase 2 study testing adebrelimab and chemotherapy in people with Efficacy and Safety of Neoadjuvant Immunotherapy for Small Cell Lung Cancer, run by Zhejiang Cancer 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 6 inclusion and 1 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 20 Aug 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

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 jinshi liu (057188122233, liujs@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR (time frame: Assessed average of 1 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Aug 2024.

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