Small Cell Lung CancerPhase 2NCT06295926
Serplulimab Combined With CCRT for LS-SCLC.
A Phase 2 study testing Serplulimab in people with Small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Serplulimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2024to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer Staging)
- Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment
- Measurable lesions based on RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of the study intervention
- Baseline hematologic, blood biochemistry, and urine biochemistry tests confirming sufficient bone marrow and organ function
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- Life expectancy of at least 6 months
- Male participants: Male participants must agree to use effective contraception during the study treatment and for at least 180 days after the last dose, and must not donate sperm during this period
- Female participants must not be pregnant or lactating, and must meet at least one of the following conditions:
- Women who are not capable of reproduction or
- Agree to use effective contraception during the treatment and for at least 180 days after the last dose
- Women capable of reproduction must undergo a serum or urine pregnancy test within 72 hours before starting the medication, and the result must be negative (minimum sensitivity 25 IU/L or equivalent units of HCG)
- Signed informed consent form
Who cannot join
- Patients with extensive-stage small cell lung cancer
- Cancer patients who have undergone surgery, radiotherapy, chemotherapy, or immunotherapy for small cell lung cancer
- LS-SCLC patients with stage I disease amenable to surgical resection
- Patients with active autoimmune diseases requiring systemic treatment (with disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed
- History of (non-infectious) pneumonia/interstitial lung disease requiring steroids or current active pneumonia/interstitial lung disease requiring steroids
- Previously diagnosed with immunodeficiency diseases such as immunoglobulin deficiency, aplastic anemia, etc.
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- Known history of human immunodeficiency virus (HIV) infection
- Concurrent active hepatitis B (defined as HBV DNA > 500 copies) and hepatitis C virus (defined as HCV RNA (+)) infection
- Known active tuberculosis history (tuberculin bacillus)
- Receipt of live vaccine or attenuated live vaccine within 30 days prior to the first study intervention. Use of inactivated vaccines is allowed. Live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chickenpox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines. Injectable seasonal influenza vaccine is generally an inactivated virus vaccine and is allowed; however, intranasal influenza vaccine (e.g., FluMist®) is an attenuated live vaccine and is not allowed
- Known other malignancy within the past 1 year that is progressing or requires active treatment. Note: Excludes adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma (excluding in situ bladder carcinoma)
- Symptomatic central nervous system metastases and/or carcinomatous meningitis
- Severe hypersensitivity reaction (≥3 grade) to nivolumab/platinum/etoposide and/or any of their excipients
- Active infection requiring systemic therapy
- Any medical condition the investigator believes would pose excessive risk to the patient. For example, poorly controlled diabetes, active infection requiring parenteral anti-infective therapy, hepatic failure, any psychiatric condition that would interfere with understanding the informed consent form (ICF). Any past or present disease, treatment, laboratory abnormality, or other condition that, in the opinion of the investigator, would confound the study results or interfere with participation throughout the study
- Known psychiatric illness or substance abuse that would interfere with compliance with trial requirements
- Pregnancy, lactation, planned pregnancy, or intent to become pregnant or father children during the expected duration of the study (from screening visit through 180 days after the last dose of investigational drug)
- Prior allogeneic tissue/organ transplantation
- Patients unable to comply with study visits
- Currently participating in or has used other investigational drugs or devices
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
- Recruiting
Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Yan Xu, Dr., 8601069155154, maraxu@163.com
Mengzhao Wang
About this study
Official title: A Single-arm Phase II Clinical Trial of Serplulimab Combined With Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer(LS-SCLC).
Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis.
Read the detailed description
The study plans to include a total of 96 patients who will receive first-line treatment consisting of 4 cycles of etoposide plus cisplatin/carboplatin and concurrent thoracic radiotherapy combined with Surlidumab immunotherapy. Following CCRT+Surlidumab treatment, patients will undergo Surlidumab consolidation therapy until disease progression or for a duration of at least 1 year. The study aims to evaluate the progression-free survival (PFS) and overall survival (OS) of patients compared to those receiving concurrent chemoradiotherapy alone, and to explore the efficacy of immunotherapy in limited-stage small cell lung cancer. Additionally, peripheral blood samples will be collected before treatment and 1 month after CCRT to explore tumor efficacy-related biomarkers.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Serplulimab
- 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.
SerplulimabDrug
Also called Concurrent radiotherapy Maintenance therapy, Etoposide, Cisplatin, Carboplatin
Undergo 4 cycles of synchronous radiotherapy and chemotherapy combined with Sintilimab immunotherapy, followed by Sintilimab monotherapy for maintenance treatment until disease progression or up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Concurrent radiotherapy with chemotherapy (Etoposide+Cisplatin/Carboplatin) with Serplulimab, and followed by consolidation Serplulimab Receives: Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
the time length from enrollment to any of the following events: disease progression with first line therapy or death from any cause. Disease progression will be assessed according to RECIST 1.1
Measured: up to 8 weeks
Secondary outcomes (3)
Overall survival
the time length from enrollment to death from any cause.
Measured: up to 8 weeks
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Evaluate adverse events of any cause, treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0
Measured: up to 8 weeks
objective response rate (ORR)
Proportion of patients with Complete and Partial Responses to first-line therapy.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start4 Apr 2024
- Primary completion25 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mengzhao Wang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295926
- Sponsor's protocol ID
- K5236
- Status last verified
- Jul 2024
- First submitted
- 27 Jan 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase II Clinical Trial of Serplulimab Combined With Concurrent Chemoradiotherapy for Limited-stage Small Cell Lung Cancer(LS-SCLC).
- ClinicalTrials.gov ID
- NCT06295926
- Acronym / sponsor ID
- K5236
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Mar 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.
Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis.
Detailed description
The study plans to include a total of 96 patients who will receive first-line treatment consisting of 4 cycles of etoposide plus cisplatin/carboplatin and concurrent thoracic radiotherapy combined with Surlidumab immunotherapy. Following CCRT+Surlidumab treatment, patients will undergo Surlidumab consolidation therapy until disease progression or for a duration of at least 1 year. The study aims to evaluate the progression-free survival (PFS) and overall survival (OS) of patients compared to those receiving concurrent chemoradiotherapy alone, and to explore the efficacy of immunotherapy in limited-stage small cell lung cancer. Additionally, peripheral blood samples will be collected before treatment and 1 month after CCRT to explore tumor efficacy-related biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: SerplulimabConcurrent radiotherapy with chemotherapy (Etoposide+Cisplatin/Carboplatin) with Serplulimab, and followed by consolidation Serplulimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18 years or older
- Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer Staging)
- Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment
- Measurable lesions based on RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of the study intervention
Key exclusion criteria (20 listed)
- Patients with extensive-stage small cell lung cancer
- Cancer patients who have undergone surgery, radiotherapy, chemotherapy, or immunotherapy for small cell lung cancer
- LS-SCLC patients with stage I disease amenable to surgical resection
- Patients with active autoimmune diseases requiring systemic treatment (with disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed
- History of (non-infectious) pneumonia/interstitial lung disease requiring steroids or current active pneumonia/interstitial lung disease requiring steroids
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: Concurrent radiotherapy Maintenance therapy, Etoposide, Cisplatin, CarboplatinUndergo 4 cycles of synchronous radiotherapy and chemotherapy combined with Sintilimab immunotherapy, followed by Sintilimab monotherapy for maintenance treatment until disease progression or up to 1 year. | Drug | Study arm |
Primary outcome
Progression free survival
Time frame: up to 8 weeks
the time length from enrollment to any of the following events: disease progression with first line therapy or death from any cause. Disease progression will be assessed according to RECIST 1.1
3 secondary outcomes
Overall survival
Time frame: up to 8 weeks
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: up to 8 weeks
objective response rate (ORR)
Time frame: up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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.
Mengzhao Wang, MD principal investigator
Peking Union Medical College 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 in people with Small Cell Lung Cancer, run by Peking Union Medical College 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 13 inclusion and 20 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 22 Jul 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 mengzhao Wang, MD (01069155154, mengzhaowang@sina.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 8 weeks). 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 22 Jul 2024.