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NCT05873790
Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer: An Observational Study
trial testing Serplulimab plus chemotherapy in Lung Cancer in 30 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | The First Hospital of Jilin University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 1 June 2023 |
| Primary completion | 30 June 2024 |
| Estimated completion | 31 December 2024 |
Drugs / interventions tested
- Serplulimab plus chemotherapy — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
Sponsor
The First Hospital of Jilin University
Who can join
Adults 18 to 75, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Small cell lung cancer (SCLC) is one of the most aggressive lung cancer subtypes, accounting for approximately 15-20% of total lung cancer cases. Although SCLC is relatively sensitive to chemotherapy, it is highly susceptible to recurrence. The advent of immunotherapy has revolutionized the clinical practice of oncology, and the newly released results of the ASTRUM-005 study have led to the incorporation of Serplulimab into the first-line treatment of extensive-stage SCLC. Although immunotherapy in combination with chemotherapy is currently the most promising regimen, due to the limited understanding of genetic alterations and the marked genetic heterogeneity of SCLC, treatment responsiveness varies greatly. Thus, there is an urgent need to find molecular biomarkers that can effectively predict prognosis and further suggest the effectiveness of this new treatment mode. Minimal residual disease (MRD) refers to the presence of tumor cells disseminated from the primary lesion to distant organs in patients who lack any clinical or radiological signs of metastasis or residual tumor cells left behind after local therapy that eventually lead to local recurrence. These years, the development of real-time, high-sensitivity liquid biopsy assays have enabled the identification of MRD in individual patients with cancer. Multiple studies have demonstrated that detection of MRD dynamics following definitive therapy for solid cancers is strongly prognostic and has extremely high positive predictive value for risk of recurrence and treatment efficacy. The aim of this study was to explore the predictive value of MRD dynamics on disease prognosis before and after the first-line treatment of Serplulimab in combination with chemotherapy for extensive-stage SCLC.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05873790
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05873790 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Hospital of Jilin University
- Last refreshed: 24 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05873790.
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