Clinical trial · Interventional

Efficacy and Safety of Serplulimab With Chemotherapy and Aspirin in Untreated Extensive-Stage Small Cell Lung Cancer

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.

NCT06554535CI-TRIAL-00079847not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
ECOG Performance Status Score of 0 or 1	—	UNRESOLVED	—
Expected Survival ≥3 Months	—	UNRESOLVED	—
Extensive-Stage Small Cell Lung Cancer	Lung Small Cell Carcinoma	CURATED_BROADER	0.78
Treatment-naïve for Systemic Therapy Targeting Extensive-Stage Small Cell Lung Cancer	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Serplulimab，Platinum-based Chemotherapy，Aspirin	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Serplulimab + Chemotherapy + Aspirin
interventionNames
1. Drug: Serplulimab，Platinum-based Chemotherapy，Aspirin

Primary outcomes (1)

measure
Progression-Free Survival
timeFrame
Up to 2 years
description
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).

Secondary outcomes (4)

measure
Two-Year Overall Survival
timeFrame
2 years
description
The proportion of patients still alive two years after the start of treatment.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Males or females aged ≥ 18 years.
2. Histologically or cytologically confirmed ES-SCLC (according to the Veterans Administration Lung Cancer Group \[VALG\] staging system).
3. Treatment-naïve for systemic therapy targeting ES-SCLC.
4. 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.
5. ECOG performance status score of 0 or 1.
6. Expected survival ≥ 3 months.
7. Planned treatment with Serplulimab combined with platinum-based chemotherapy.
8. Patients who have previously taken or are currently taking Bayer Aspirin are allowed.

Exclusion Criteria:

1. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
2. Currently receiving other anticoagulant therapy.
3. Previous systemic anti-tumor therapy.
4. Contraindications to the use of Serplulimab, Aspirin, or chemotherapy.

References

Publications (1)

BACKGROUNDCheng 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. PMID 36166026