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Respiratory Tract NeoplasmsPhase 2NCT06177925

A Phase Ⅱ Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy for Extensive-Stage Oligometastatic SCLC

A Phase 2 study testing Adebrelimab, Carboplatin/Cisplatin and Etoposide in people with Respiratory Tract Neoplasms and Thoracic Neoplasms, run by Nanfang Hospital, Southern Medical University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Adebrelimab, Carboplatin/Cisplatin and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteChina
Study dates
10 Dec 2023to 30 Sep 2026
Phase
Phase 2
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

  • Signed inform consent form
  • Age >= 18 years and <= 75 years
  • Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)，the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Expected survival time ≥ 3 months
  • Patients must submit a pre-treatment tumor tissue sample during the study.
  • Adequate hematologic and end organ function

Who cannot join

  • Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 1 week prior to randomization
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled or symptomatic hypercalcemia
  • Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
  • History of autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease
Show all 13Show fewer
  • Prior treatment with immune checkpoint blockade therapies
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease.
  • Significant cardiovascular disease
  • Prior allogeneic bone marrow transplantation or solid organ transplant
  • Treatment with systemic immunosuppressive medications within 1 weeks prior to randomization
  • History of hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins, carboplatin or etoposide
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou

    ZhongYi Dong, +86 15626217674, 331576705@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.

Read the detailed description

Participants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent chemoradiotherapy(thoracic radiation therapy and SBRT for metastases,combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles).Then participants will receive Adebrelimab combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles,followed by Adebrelimab maintenance until persistent radiographic PD, intolerable toxicity or withdrawal of consent during the maintenance phase.

Being tested
Adebrelimab, Carboplatin/Cisplatin, Etoposide, Radiation therapy
Keywords
Extensive stage small cell lung cancer, Oligometastasis, Adebrelimab, Chemotherapy, Radiotherapy
Medical subject headings
Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms

What participants receive

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

  • AdebrelimabDrug

    Adebrelimab intravenous infusion will be administered during the induction phase (Cycles 1-2 ) and maintenance phase.

  • Carboplatin/CisplatinDrug

    Carboplatin/Cisplatin intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

  • EtoposideDrug

    Etoposide intravenous infusion will be administered during the induction phase, concurrent chemoradiotherapy phase and maintenance phase(Cycles 1-4 or 6).

  • Radiation therapyRadiation

    IMRT for thoracic of 45--55Gy in 15-22 fractions，SBRT for metastases during the concurrent chemoradiotherapy phase

Study groups in NCT06177925
Study groupRoleWhat they receive
Treatment (Adebrelimab, chemotherapy, radiation therapy)ExperimentalParticipants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent chemoradiotherapy(thoracic radiation therapy and SBRT for metastases,combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles).Then participants will receive Adebrelimab combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles,followed by Adebrelimab maintenance until persistent radiographic PD, intolerable toxicity or withdrawal of consent during the maintenance phase.
Receives: Drug: Adebrelimab; Drug: Carboplatin/Cisplatin; Drug: Etoposide; Radiation: Radiation therapy

What is being measured

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

  1. Progression-Free Survival (PFS)

    Measured: up to approximately 30 months

Secondary outcomes (7)

  1. Overall Survival (OS)

    Measured: up to approximately 30 months

  2. Objective Response Rate (ORR)

    Measured: up to approximately 30 months

  3. Disease control rate (DCR)

    Measured: up to approximately 30 months

  4. Duration of Response (DOR)

    Measured: up to approximately 30 months

  5. Percentage of Participants Alive at 1 Year and 2 Years

    Measured: 1 year, 2 years

  6. Percentage of Participants Alive and Without PD at 6 Months and 1 Year

    Measured: 6 months, 1 year

  7. Percentage of Participants with Adverse Events Or Serious Adverse Events

    Measured: up to approximately 30 months

Timeline

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

  1. First posted20 Dec 2023
  2. Study start10 Dec 2023 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Sep 2026 (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
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06177925
Sponsor's protocol ID
NFEC-2023-465
Status last verified
Dec 2023
First submitted
11 Dec 2023
Last updated
20 Dec 2023
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, Carboplatin/Cisplatin and Etoposide in people with Respiratory Tract Neoplasms and Thoracic Neoplasms, run by Nanfang Hospital, Southern Medical University 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 7 inclusion and 13 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 20 Dec 2023. 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?

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?

Progression-Free Survival (PFS) (time frame: up to approximately 30 months). 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 NCT06177925.

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 Dec 2023.

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