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Limited Stage Small Cell Lung CancerPhase 2NCT05443646

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

A Phase 2 study testing HLX10, hypofractionated radiotherapy and Prophylactic Cranial Irradiation (PCI) in people with Limited Stage Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a multi-center, Single-arm Phase II study to evaluate the clinical efficacy and safety of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Limited Stage Small Cell Lung Cancer
What is being tested?
HLX10, hypofractionated radiotherapy and Prophylactic Cranial Irradiation (PCI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesChina
Study dates
23 Sep 2022to 30 Jun 2025
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

  • Age 18-75 years; ECOG score 0-1.
  • Histologically or cytologically confirmed small cell lung cancer.
  • Limited stage, defined as the tumor confined to one side of the thoracic cavity including ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increased metabolism on PET-CT considering metastatic lymph nodes); unless cytologically confirmed malignant pleural effusion, the thickness of pleural effusion on chest CT is less than 1 cm; (stage I-IIIB without intrapulmonary metastasis in the 7th edition of AJCC staging in 2009) .
  • No other previous anti-tumor history, at least 3 months of expected survival.
  • No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

Who cannot join

  • Histologically or cytologically confirmed mixed SCLC.
  • Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
  • Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
  • Patients with other active malignancies within 5 years or at the same time.
  • Subjects with known history of severe allergy to any monoclonal antibody.
  • Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
  • In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.

Trial locations and contacts

2 sites in 1 country.

Nan Bi, Doctor contact

86010-87788799

binan_email@163.com

China2 sites, 2 recruiting

  • Jiamusi Cancer Hospital

    Jiamusi, Heilongjiang, 154007

    Xiaohong Zhou

    Recruiting

  • Shanxi Province Cancer Hospital

    Taiyuan, Shanxi, 030013

    Jianzhong Cao

    Recruiting

Other trials in China

About this study

Official title: A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

This study is a multi-center, Single-arm Phase II study to evaluate the clinical efficacy and safety of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

Read the detailed description

All eligible patients after screening will receive up to four cycles chemotherapy. Recommended regimens are etoposide 100 mg/m2 intravenously on day 1-3 in combination with cisplatin 75 mg/m2 intravenously on day 1 or carboplatin AUC=5 every 3 weeks.

A total of 45Gy in 15 fractions over 3 weeks will be delivered. PCI is routinely scheduled for patients without progression after chemoradiotherapy, and hippocampal avoidance is highly recommended. 25Gy in 10 fractions over 2 weeks to the brain will be prescribed. Intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) technique are required. Patients without disease progression will receive an intravenous infusion of serplulimab 300mg every 3 weeks. Treatment of serplulimab should be continued until disease progression, intolerable toxicity, withdrawal of consent, or to a maximum of 1 year. Continuation of immunotherapy after disease progression is acceptable per investigators' discretion.

The investigator and IRRC respectively assess the tumor images according to RECIST 1.1.

Being tested
HLX10, hypofractionated radiotherapy, Prophylactic Cranial Irradiation (PCI)

What participants receive

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

  • HLX10Drug

    Also called Serplulimab

    HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

    300mg Q3W

  • hypofractionated radiotherapyRadiation

    45Gy/3Gy/3week

  • Prophylactic Cranial Irradiation (PCI)Radiation

    25Gy/2.5Gy/2week

Study groups in NCT05443646
Study groupRoleWhat they receive
HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated RadiotherapyExperimentalParticipants will receive at least 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) concurrently with Hypofractionated Radiotherapy, followed by HLX10 300 mg every 3 weeks (Q3W) with maximum 1 years or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
Receives: Drug: HLX10; Radiation: hypofractionated radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)

What is being measured

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

  1. Progression-free survival

    To evaluate the progression-free survival (PFS) of HLX10 (Serplulimab) consolidation therapy after concurrent hypofractionated radiotherapy with chemotherapy in limited-stage small cell lung cancer according to RECIST 1.1 criteria

    Measured: up to 12 months

Secondary outcomes (3)

  1. Overall survival(OS）

    Overall survival time is defined as the time from the date of the patient's first dose of HLX10 to the date of any documented death due to any cause.

    Measured: up to 24 months

  2. Objective response rate (ORR)

    Proportion of subjects achieving a best response of complete response (CR) and partial response (PR) as assessed by RECIST 1.1.

    Measured: up to 24 months

  3. Time to treatment failure (TTF)

    Time to disease progression, death, withdrawal due to adverse events, patient refusal to continue the study, or use of a new treatment from the first HLX10 administration.

    Measured: up to 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 posted5 Jul 2022
  2. Study start23 Sep 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2025 (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
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443646
Sponsor's protocol ID
ASTRUM-LC01
Status last verified
May 2024
First submitted
29 Jun 2022
Last updated
7 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu Y, Deng L, Wang J, Zhang T, Cao J, Zhou X, Duan J, Bi N. Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol. BMJ Open. 2025 May 21;15(5):e085552. doi: 10.1136/bmjopen-2024-085552.

    PubMed 40398957

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HLX10, hypofractionated radiotherapy and Prophylactic Cranial Irradiation (PCI) in people with Limited Stage Small Cell Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites 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 5 inclusion and 7 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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Contact Nan Bi, Doctor (86010-87788799, binan_email@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: up to 12 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 NCT05443646, 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 7 May 2024.

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