Extensive-Stage Small Cell Lung CancerPhase 2NCT06554535
Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing Serplulimab，Platinum-based Chemotherapy，Aspirin in people with Extensive-Stage Small Cell Lung Cancer and Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Trial summary
Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer, Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer, ECOG Performance Status Score of 0 or 1
- What is being tested?
- Serplulimab，Platinum-based Chemotherapy，Aspirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Oct 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
- Males or females aged ≥ 18 years.
- Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Cancer Group [VALG] staging system).
- Treatment-naïve for systemic therapy targeting ES-SCLC.
- Patients must have at least one tumor lesion that meets the following criteria: previously untreated, accurately measurable, with a longest diameter ≥ 10 mm at baseline (for lymph nodes, short axis ≥ 15 mm), measurable by chest CT or PET-CT, as long as accurate repeat measurements can be performed.
- ECOG performance status score of 0 or 1.
- Expected survival ≥ 3 months.
- Planned treatment with Serplulimab combined with platinum-based chemotherapy.
- Patients who have previously taken or are currently taking Bayer Aspirin are allowed.
Who cannot join
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Currently receiving other anticoagulant therapy.
- Previous systemic anti-tumor therapy.
- Contraindications to the use of Serplulimab, Aspirin, or chemotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-center, Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Platinum-based Chemotherapy and Bayer Aspirin in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.
Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.
Read the detailed description
In 2020, global cancer burden data showed 2.2 million new cases of lung cancer, ranking second, with 1.8 million deaths, far surpassing other cancer types and ranking first in cancer-related mortality. In 2020, China reported 820,000 new cases of lung cancer, with 710,000 deaths, accounting for 23.8% of all cancer deaths, making lung cancer the leading cause of cancer incidence and mortality in the country. Small cell lung cancer (SCLC), originating from neuroendocrine-differentiated epithelial cells, accounts for 15-20% of all lung cancers. Using the Veterans Administration (VA) staging system, SCLC is classified into limited-stage and extensive-stage disease. The majority of patients present with symptoms related to metastatic lesions at diagnosis, and only 30-40% are diagnosed at the limited stage. Extensive-stage patients, due to widespread metastasis and poor physical condition, often can only receive supportive care, resulting in shorter survival times.
Based on theoretical foundations, cytotoxic chemotherapy kills tumor cells (TC), exposing the immune system to high levels of tumor antigens. Therefore, compared to standard chemotherapy alone, activating tumor-specific T-cell immunity by inhibiting the PD-L1/PD-1 signaling pathway may provide deeper and more durable responses. Recent studies have explored the potential of combining immunotherapy with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
Serplulimab is an innovative PD-1 inhibitor developed by Henlius, a recombinant humanized IgG4 monoclonal antibody. It has characteristics such as structural stability, weak antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), moderate antibody-dependent cellular phagocytosis (ADCP) effects, large epitope binding area, high affinity, slow dissociation, strong anti-tumor activity, and low immunogenicity. Clinical studies involving serplulimab combined with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer have been conducted to evaluate its safety and efficacy.
Aspirin (ASP), originally extracted from willow bark, is a small molecule compound with various effects such as antipyretic, anti-inflammatory, analgesic, and antiplatelet aggregation. In recent years, research has discovered new anti-cancer effects of aspirin, and it has been confirmed to promote tumor cell apoptosis. Additionally, preclinical evidence suggests that antiplatelet drugs and immune checkpoint inhibitors (ICIs) may have potential synergistic effects, which warrant further investigation in the context of lung cancer treatment.
PD-1 inhibitors, as the standard first-line treatment for extensive-stage small cell lung cancer, have been proven in numerous studies to have good efficacy and safety. Aspirin, as a classic anticoagulant, has advantages such as safety, affordability, and easy availability. Lung cancer patients are inherently in a hypercoagulable state, and if aspirin's synergistic anti-tumor effects and its potential to reduce adverse events such as fever and thrombosis can be further confirmed, it will have a significant impact on the treatment of ES-SCLC patients, potentially achieving enhanced therapeutic effects. Therefore, we plan to conduct this observational Phase II study to evaluate the efficacy and safety of combining the PD-1 inhibitor serplulimab, platinum-based chemotherapy, and Bayer aspirin as first-line treatment for extensive-stage small cell lung cancer.
- Conditions
- Extensive-Stage Small Cell Lung Cancer, Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer, ECOG Performance Status Score of 0 or 1, Expected Survival ≥3 Months
- Being tested
- Serplulimab，Platinum-based Chemotherapy，Aspirin
- Keywords
- ES-SCLC, Chemo-immunotherapy combination, Aspirin
- 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.
Serplulimab，Platinum-based Chemotherapy，AspirinDrug
Participants will receive an induction therapy consisting of Serplulimab (4.5 mg/kg IV on Day 1), Carboplatin (AUC 5 IV on Day 1) or Cisplatin (75 mg/m² IV on Day 1), Etoposide (100 mg/m² IV on Days 1-3), and Bayer Aspirin (100 mg PO daily). This induction phase will be administered every 3 weeks for 4 cycles. Following the induction phase, participants will transition to a maintenance therapy phase where they will continue to receive Serplulimab (4.5 mg/kg IV on Day 1, every 3 weeks) and Bayer Aspirin (100 mg PO daily) until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Serplulimab + Chemotherapy + Aspirin | Experimental | Not described Receives: Drug: Serplulimab，Platinum-based Chemotherapy，Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
The time from the start of treatment until the first documented disease progression or death from any cause, whichever occurs first, as assessed by RECIST criteria (Response Evaluation Criteria in Solid Tumors).
Measured: Up to 2 years
Secondary outcomes (4)
Two-Year Overall Survival
The proportion of patients still alive two years after the start of treatment.
Measured: 2 years
Objective Response Rate
The proportion of patients with a measurable reduction in tumor size as per RECIST criteria, including complete and partial responses.
Measured: Up to 2 years
Disease Control Rate
The proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) as per RECIST criteria.
Measured: Up to 2 years
Incidence of Adverse Events
The number and severity of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extensive-Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554535
- Sponsor's protocol ID
- AB20240810
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.
PubMed 36166026
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Platinum-based Chemotherapy and Bayer Aspirin in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT06554535
- Acronym / sponsor ID
- AB20240810
- Conditions
- Extensive-Stage Small Cell Lung Cancer, Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer, ECOG Performance Status Score of 0 or 1, Expected Survival ≥3 Months
- Keywords
- ES-SCLC, Chemo-immunotherapy combination, Aspirin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 15 Aug 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.
Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.
Detailed description
In 2020, global cancer burden data showed 2.2 million new cases of lung cancer, ranking second, with 1.8 million deaths, far surpassing other cancer types and ranking first in cancer-related mortality. In 2020, China reported 820,000 new cases of lung cancer, with 710,000 deaths, accounting for 23.8% of all cancer deaths, making lung cancer the leading cause of cancer incidence and mortality in the country. Small cell lung cancer (SCLC), originating from neuroendocrine-differentiated epithelial cells, accounts for 15-20% of all lung cancers. Using the Veterans Administration (VA) staging system, SCLC is classified into limited-stage and extensive-stage disease. The majority of patients present with symptoms related to metastatic lesions at diagnosis, and only 30-40% are diagnosed at the limited stage. Extensive-stage patients, due to widespread metastasis and poor physical condition, often can only receive supportive care, resulting in shorter survival times.
Based on theoretical foundations, cytotoxic chemotherapy kills tumor cells (TC), exposing the immune system to high levels of tumor antigens. Therefore, compared to standard chemotherapy alone, activating tumor-specific T-cell immunity by inhibiting the PD-L1/PD-1 signaling pathway may provide deeper and more durable responses. Recent studies have explored the potential of combining immunotherapy with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
Serplulimab is an innovative PD-1 inhibitor developed by Henlius, a recombinant humanized IgG4 monoclonal antibody. It has characteristics such as structural stability, weak antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), moderate antibody-dependent cellular phagocytosis (ADCP) effects, large epitope binding area, high affinity, slow dissociation, strong anti-tumor activity, and low immunogenicity. Clinical studies involving serplulimab combined with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer have been conducted to evaluate its safety and efficacy.
Aspirin (ASP), originally extracted from willow bark, is a small molecule compound with various effects such as antipyretic, anti-inflammatory, analgesic, and antiplatelet aggregation. In recent years, research has discovered new anti-cancer effects of aspirin, and it has been confirmed to promote tumor cell apoptosis. Additionally, preclinical evidence suggests that antiplatelet drugs and immune checkpoint inhibitors (ICIs) may have potential synergistic effects, which warrant further investigation in the context of lung cancer treatment.
PD-1 inhibitors, as the standard first-line treatment for extensive-stage small cell lung cancer, have been proven in numerous studies to have good efficacy and safety. Aspirin, as a classic anticoagulant, has advantages such as safety, affordability, and easy availability. Lung cancer patients are inherently in a hypercoagulable state, and if aspirin's synergistic anti-tumor effects and its potential to reduce adverse events such as fever and thrombosis can be further confirmed, it will have a significant impact on the treatment of ES-SCLC patients, potentially achieving enhanced therapeutic effects. Therefore, we plan to conduct this observational Phase II study to evaluate the efficacy and safety of combining the PD-1 inhibitor serplulimab, platinum-based chemotherapy, and Bayer aspirin as first-line treatment for extensive-stage small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serplulimab + Chemotherapy + Aspirin | Experimental | Drug: Serplulimab，Platinum-based Chemotherapy，Aspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females aged ≥ 18 years.
- Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Cancer Group [VALG] staging system).
- Treatment-naïve for systemic therapy targeting ES-SCLC.
- Patients must have at least one tumor lesion that meets the following criteria: previously untreated, accurately measurable, with a longest diameter ≥ 10 mm at baseline (for lymph nodes, short axis ≥ 15 mm), measurable by chest CT or PET-CT, as long as accurate repeat measurements can be performed.
- ECOG performance status score of 0 or 1.
Key exclusion criteria (4 listed)
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
- Currently receiving other anticoagulant therapy.
- Previous systemic anti-tumor therapy.
- Contraindications to the use of Serplulimab, Aspirin, or chemotherapy.
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 |
|---|---|---|
| Serplulimab，Platinum-based Chemotherapy，AspirinParticipants will receive an induction therapy consisting of Serplulimab (4.5 mg/kg IV on Day 1), Carboplatin (AUC 5 IV on Day 1) or Cisplatin (75 mg/m² IV on Day 1), Etoposide (100 mg/m² IV on Days 1-3), and Bayer Aspirin (100 mg PO daily). This induction phase will be administered every 3 weeks for 4 cycles. Following the induction phase, participants will transition to a maintenance therapy phase where they will continue to receive Serplulimab (4.5 mg/kg IV on Day 1, every 3 weeks) and Bayer Aspirin (100 mg PO daily) until disease progression or intolerable toxicity. | Drug | Serplulimab + Chemotherapy + Aspirin |
Primary outcome
Progression-Free Survival
Time frame: Up to 2 years
The time from the start of treatment until the first documented disease progression or death from any cause, whichever occurs first, as assessed by RECIST criteria (Response Evaluation Criteria in Solid Tumors).
4 secondary outcomes
Two-Year Overall Survival
Time frame: 2 years
Objective Response Rate
Time frame: Up to 2 years
Disease Control Rate
Time frame: Up to 2 years
Incidence of Adverse Events
Time frame: Up to 2 years
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 15 Aug 2024.
- Background: PubMed 36166026Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab，Platinum-based Chemotherapy，Aspirin in people with Extensive-Stage Small Cell Lung Cancer and Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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 He Yong, MD (6-23-68757791, eyong8998@126.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 2 years). 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 NCT06554535, 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 15 Aug 2024.