Extensive Stage Lung Small Cell CancerPhase 2NCT06350162
Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC
A Phase 2 study testing Serplulimab and Chest Radiation in people with Extensive Stage Lung Small Cell Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for 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 Lung Small Cell Cancer
- What is being tested?
- Serplulimab and Chest Radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2023to 31 Dec 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
- Voluntary participation in clinical studies; fully understand, be informed about the study and have signed the informed consent form (ICF).
- Male or female aged ≥ 18 and ≤ 75 years, at the time of signing the ICF.
- Willingness to follow and ability to complete all trial procedures.
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- No prior systemic therapy for ES-SCLC；at the end of the combination chemotherapy with serplulimab, the efficacy evaluation is CR, PR, or SD.
- At least one measurable lesion as assessed according to RECIST 1.1 , lesions that have received radiation therapy in the past are only considered measurable if they show clear progression.
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- An ECOG PS score of 0 or 1.
- An expected survival ≥ 3 months.
- Normal major organ functions
- For participants receiving therapeutic anticoagulation: stable anticoagulant regimen
- Negative human immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb) test at screening, and positive hepatitis B virus core antibody (HBcAb), no HBV-DNA test is required; or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test.
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Who cannot join
- Complete response or tumor progression occurred during the combination of serplulimab and chemotherapy treatment.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.Patients with CNS lesions treated and Asymptomatic are eligible to participate in this study if they meet all of the following criteria: Measurable lesions exist outside of CNS that meet the definition of RECISTv1.1; The patient has no history of Intracranial hemorrhage or intracerebral hemorrhage; The patient did not receive stereotactic radiotherapy within 7 days before the start of the study treatment, whole brain radiotherapy within 14 days before the start of the study treatment, or Neurosurgery resection within 28 days before the start of the study treatment; Patients do not need to continue to receive Corticosteroid treatment for CNS diseases. Allowing stable doses of anticonvulsant drugs for treatment; Transfer is limited to the cerebellum or supratentorial area (i.e. not transferred to the midbrain, pons, medulla oblongata, or spinal cord); There is no evidence to suggest progress between the completion of CNS local treatment and the initiation of study treatment; New Asymptomatic patients with central nervous system metastasis found during screening are eligible to participate in this study after receiving radiotherapy and/or surgery
- History of leptomeningeal disease.
- The total number of liver metastases was ≥3 or a single liver metastases was greater than 3cm
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
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- Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN).
- Known active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll.
- Have a history of Idiopathic pulmonary fibrosis, organized pneumonia (such as Bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or chest computed tomography (CT) at screening shows evidence of active pneumonia.
- Active or latent pulmonary tuberculosis.
- Serious cardiovascular disease (such as heart disease, myocardial infarction or cerebrovascular accident of New York Heart Association Grade II or above), unstable arrhythmia or unstable angina pectoris occurred within 3 months before the start of the study treatment.
- Major surgical procedures other than diagnosis have been performed within 4 weeks prior to the start of the study treatment, or significant surgical procedures are expected to be required during the study period.
- Malignant tumors other than small cell lung cancer (SCLC) occurred within 5 years before the start of the study treatment, but the cancer under study and malignant tumors with negligible risk of metastasis or death (such as the 5-year overall survival rate>90%) were excluded, such as fully treated cervical Carcinoma in situ, non Melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ or stage I Uterine cancer.
- Severe infection occurred within 4 weeks before the start of study treatment, including but not limited to hospitalization due to infection, Bloodstream infections, severe pneumonia or any active infection that may affect the safety of patients.
- Previously received allogeneic stem cell or solid organ transplantation.
- Any other diseases, metabolic disorders, physical examination abnormalities, or clinical laboratory abnormalities that may affect the interpretation of results or treatment complications that may pose a high risk to patients, may result in contraindications to the use of research drugs.
- Received attenuated live vaccines within 4 weeks prior to the start of research treatment, or expected to receive such vaccines during the treatment period of sulumab or within 5 months after the last administration of serplulimab.
- Currently undergoing anti HBV treatment.
- Received any other investigational drug treatment within 28 days prior to the start of the study treatment.
- Previous treatment with CD137 agonists or immune checkpoint blockade therapy, including anti CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies.
- Received systemic immunostimulatory therapy (including but not limited to interferon and interleukin-2 [IL-2]) within 4 weeks prior to the start of study treatment or within 5 drug elimination half-lives (whichever is longer).
- Systemic immunosuppressive drugs (including but not limited to Corticosteroid, Cyclophosphamide, Azathioprine, methotrexate, Thalidomide and anti TNF - α preparations) were used within 2 weeks before the start of the study treatment, or systemic immunosuppressive drugs were expected to be used during the study treatment, with the following exceptions: 1)Patients receiving short-term, low-dose systemic immunosuppressive drugs or patients receiving one-time pulse therapy of systemic immunosuppressive drugs (for example, receiving Corticosteroid for 48 hours to treat contrast allergy) may be qualified to participate in this study after being confirmed by the medical supervisor; 2) Patients who receive Mineralocorticoid (such as fluhydrocortisone), inhaled or low-dose Corticosteroid to treat Chronic obstructive pulmonary disease (COPD) or asthma, or low-dose Corticosteroid to treat orthostatic Hypotension or adrenal insufficiency are eligible to participate in this study.
- Has a history of severe allergies to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity to serplulimab.
- Known hypersensitivity to carboplatin or etoposide.
- Pregnant or lactating women, or women who plan to become pregnant during the study treatment or at least 5 months after the last administration of Slulimab or 6 months after the last administration of cisplatin/carboplatin or Etoposide.
- Researchers determine that patients cannot benefit from TRT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Combination Therapy With Serplulimab and RT in Patients With ES-SCLC Who Have Not Progressed After Treat With Serplulimab Combined Chemotherapy
This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer .
Read the detailed description
This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer . Immunotherapy with monoclonal antibodies, such as Serplulimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to Serplulimab may extend the time without extensive small cell lung cancer growing or spreading compared to Serplulimab alone.
- Conditions
- Extensive Stage Lung Small Cell Cancer
- Being tested
- Serplulimab, Chest Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerplulimabDrug
Also called HLX10
4.5mg/kg,IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days.
Chest RadiationRadiation
30Gy-45Gy/QD/3Gy
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab+Radiation Therapy | Experimental | Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-3 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial. Receives: Drug: Serplulimab; Radiation: Chest Radiation |
| Serplulimab | Active comparator | Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial. Receives: Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Progression-free survival rate
PFS rate after 1 year after randomization
Measured: up to 1year
Secondary outcomes (4)
Progression-free survival (PFS)
defined as time from randomization to the date of first observed disease progression (investigator assessment according to RECIST 1.1) or death from any cause
Measured: up to 12 months after last patient randomized
Overall survival (OS)
defined as the time from initiation of study treatment to death from any cause
Measured: up to 22 months after last patient randomized
Duration of response (DOR)
defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Measured: up to approximately 24 months
Disease control rate (DCR)
defined as the proportion of participants who have a best overall response of CR or PR or stable disease (SD), as determined by the investigator according to RECIST v1.1.
Measured: up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start18 Oct 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive Stage Lung Small Cell CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Yun, MD, Zhejiang Cancer Hospital
- Investigators
- Yun Fan, PHD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350162
- Sponsor's protocol ID
- ASTRUM-LC12
- Status last verified
- Apr 2024
- First submitted
- 25 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Combination Therapy With Serplulimab and RT in Patients With ES-SCLC Who Have Not Progressed After Treat With Serplulimab Combined Chemotherapy
- ClinicalTrials.gov ID
- NCT06350162
- Acronym / sponsor ID
- ASTRUM-LC12
- Conditions
- Extensive Stage Lung Small Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer .
Detailed description
This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer . Immunotherapy with monoclonal antibodies, such as Serplulimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to Serplulimab may extend the time without extensive small cell lung cancer growing or spreading compared to Serplulimab alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serplulimab+Radiation Therapy | Experimental | Drug: Serplulimab, Radiation: Chest RadiationPatients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-3 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial. |
| Serplulimab | Active comparator | Drug: SerplulimabPatients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Voluntary participation in clinical studies; fully understand, be informed about the study and have signed the informed consent form (ICF).
- Male or female aged ≥ 18 and ≤ 75 years, at the time of signing the ICF.
- Willingness to follow and ability to complete all trial procedures.
- Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- No prior systemic therapy for ES-SCLC；at the end of the combination chemotherapy with serplulimab, the efficacy evaluation is CR, PR, or SD.
Key exclusion criteria (27 listed)
- Complete response or tumor progression occurred during the combination of serplulimab and chemotherapy treatment.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.Patients with CNS lesions treated and Asymptomatic are eligible to participate in this study if they meet all of the following criteria: Measurable lesions exist outside of CNS that meet the definition of RECISTv1.1; The patient has no history of Intracranial hemorrhage or intracerebral hemorrhage; The patient did not receive stereotactic radiotherapy within 7 days before the start of the study treatment, whole brain radiotherapy within 14 days before the start of the study treatment, or Neurosurgery resection within 28 days before the start of the study treatment; Patients do not need to continue to receive Corticosteroid treatment for CNS diseases. Allowing stable doses of anticonvulsant drugs for treatment; Transfer is limited to the cerebellum or supratentorial area (i.e. not transferred to the midbrain, pons, medulla oblongata, or spinal cord); There is no evidence to suggest progress between the completion of CNS local treatment and the initiation of study treatment; New Asymptomatic patients with central nervous system metastasis found during screening are eligible to participate in this study after receiving radiotherapy and/or surgery
- History of leptomeningeal disease.
- The total number of liver metastases was ≥3 or a single liver metastases was greater than 3cm
- Uncontrolled tumor-related pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SerplulimabAlso: HLX104.5mg/kg,IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days. | Drug | Serplulimab, Serplulimab+Radiation Therapy |
| Chest Radiation30Gy-45Gy/QD/3Gy | Radiation | Serplulimab+Radiation Therapy |
Primary outcome
1-year Progression-free survival rate
Time frame: up to 1year
PFS rate after 1 year after randomization
4 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 12 months after last patient randomized
Overall survival (OS)
Time frame: up to 22 months after last patient randomized
Duration of response (DOR)
Time frame: up to approximately 24 months
Disease control rate (DCR)
Time frame: up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Fan, PHD principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab and Chest Radiation in people with Extensive Stage Lung Small Cell 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 16 inclusion and 27 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 5 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Fan, PHD (0571-88122092, fanyun@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Progression-free survival rate (time frame: up to 1year). 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 5 Apr 2024.